Dissertations / Theses: 'Adverse side effects'

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Lau, Phyllis Min-yu. "Adverse drug reactions in oncology." Monash University, Dept. of Pharmacy Practice, 2003. http://arrow.monash.edu.au/hdl/1959.1/5549.

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Ödmark, Inga-Stina. "Hormone replacement therapy : benefits and adverse effects." Doctoral thesis, Umeå universitet, Obstetrik och gynekologi, 2004. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-243.

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Background: Numerous studies have shown that estrogen replacement therapy (ERT) is an effective treatment for vasomotor symptoms, insomnia and vaginal dryness. Beneficial effects have also been shown on lipid patterns and on the incidence of osteoporotic fractures. As ERT increases the risk of endometrial adenocarcinoma, combinations with various progestogens have been developed in order to protect the endometrium. However, the addition of progestogens tends to reduce the beneficial effects of estrogens on mood, cognition and lipid metabolism. The added progestogen often causes side effects such as irritability and depression. There is evidence that the effect on wellbeing varies between women and with the type of progestogen used. Women who prefer to avoid withdrawal bleedings can be given continuous combined hormone replacement therapy (HRT). Unfortunately, irregular bleedings are common at the beginning of treatment and reduces compliance. Recently, several studies have reported an increased risk of breast cancer and venous thrombosis, and therefore long-term treatment with HRT for women without climacteric symptoms is no longer recommended. The ongoing debate has, for the time being, resulted in a recommendation that improving quality of life (QoL) by treatment of climacteric symptoms should be the only indication for prescribing HRT. Aims and methods: The aims of the study were to investigate bleeding patterns, changes in wellbeing at onset and during long-term treatment, and lipid and lipoprotein profiles with two different types of continuous combined HRT. In addition, women starting, and women switching from mainly sequential HRT were compared. The design was a randomised, double-blind, one year, prospective, multicentre study including 249 healthy postmenopausal women who were given continuous daily oral treatment with either combined 0.625mg conjugated estrogen (CE) and 5mg medroxyprogesterone acetate (MPA) or combined 2mg 17β - estradiol (E2) and 1mg norethisterone acetate (NETA). Bleedings, if any, were recorded daily throughout the study. The main outcome measures (changes in wellbeing and climacteric symptoms) consisted of daily ratings of 12 items on a validated symptom scale. Serum concentrations of lipids and lipoproteins were measured at baseline and after one year of treatment. Results and conclusions: The majority of drop-outs were confined to the first three months, and the main reasons were bleedings and/or decreased wellbeing. Drop-outs were three times more common in the E2/NETA group. During the first month, 67% of the women reported irregular bleedings. The number of bleeding days decreased on both treatments during the first four months. Treatment with CE/MPA resulted in less irregular bleedings and a shorter time to amenorrhoea compared to E2/NETA. As expected, "starters" experienced more sweats than "switchers" at the onset of treatment, but both groups improved significantly. Side effects such as breast tenderness, swelling, depression and irritability appeared during the first treatment week in both groups. The side effects of HRT appeared much more quickly than the benefits and were more frequent in women with a history of premenstrual syndrome (PMS). Breast tenderness was more common in the E2/NETA group throughout the whole study period. Apart from that, there were no differences between the two treatment regimens as regards effects on well-being at the end of the study. Lipoprotein(a) levels, an important risk factor for cardiovascular disease, decreased in both treatment groups. Triglyceride levels increased in women treated with CE/MPA, and levels of total cholesterol, high density lipoprotein and low density lipoprotein fell in the E2/NETA group. In conclusion, treatment with E2/NETA caused more bleeding problems than treatment with CE/MPA. CE/MPA was better tolerated than E2/NETA at the beginning of the study, but among the women remaining in the study there was no difference in QoL between the two treatment groups. HRT counselling should take into account that a history of PMS increases the likelihood of side effects and that these may precede any beneficial effects. Both treatments produced beneficial effects on lipid and lipoprotein levels, and neither of the regimens was superior in this respect.

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Kunac, Desirée L., and n/a. "Adverse drug events and medication errors in a paediatric inpatient population." University of Otago. Dunedin School of Medicine, 2005. http://adt.otago.ac.nz./public/adt-NZDU20060707.161220.

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Background. Medication-related patient injuries (adverse drug events, ADEs) are an important problem in all hospitalised populations; however, the potential for injury is reported to be greater in children than adults. Many ADEs are due to error and therefore could be prevented. Data regarding the risk factors (or predictors) for these events in paediatric inpatients is limited. It was hypothesised that "identification of risk factors for ADEs and medication errors in the paediatric inpatient setting will inform likely prevention strategies". Aims. To determine the frequency, nature and risk factors for ADEs and potential ADEs occurring in a paediatric inpatient population; to assess the vulnerable processes in the neonatal intensive care unit (NICU) medication use process; and to provide recommendations for the targeting of likely prevention strategies. Setting. A general paediatric ward (PW), postnatal ward (PNW) and NICU of a University- affiliated urban general hospital. Design. There were two study components: the medEVENT study which involved identification of actual ADEs and potential ADEs over a twelve week period, through prospective review of medical records, medication charts and administration records along with voluntary and solicited staff report and parent interview; and the FMEA study which used a proactive risk assessment technique, Failure Mode and Effect Analysis (FMEA), to rank all potential failures in the NICU medication use process according to risk. Results. In the MedEVENT study 3160 prescription episodes were reviewed (which represented 520 admissions, 3037 patient-days) and revealed a total of 67 ADEs and 77 potential ADEs. The greatest number of events occurred in NICU with very few events in the PNW. However, paediatric surgical admissions experienced the highest rate of ADEs per 1000 patient-days (80) as compared to medical (65) then NICU admissions (19). Over half of the ADEs were deemed preventable, 38 (57%), with the �more serious� ADEs more likely to be preventable than �not serious� ADEs. The impact on hospital resources was considerable with the cost attributed to extra bed days due to ADEs to be $NZD 50,000. Dosing errors were the most common type of error, particularly when prescribing and administering medications. Antibacterial and narcotic analgesics were commonly implicated, as was the intravenous route of administration. Few events were related to unlicensed use of medications. For ADEs, the major risk factors when analysed by admission, were greater medication exposure and increasing age; by prescription, were increasing age, oral route and narcotics and antibacterial agents; for paediatric ward admission, were increasing age and increased length of stay; and for NICU admission, no major risk factors emerged. For potential ADEs, the major risk factors when analysed by admission were greater medication exposure; by prescription, were junior prescriber, intravenous route, narcotics and antibacterials; for paediatric ward admission, were junior prescriber and narcotics; and for NICU admission were antibacterials, electrolytes and umbilical venous catheter administration. Neither ADEs nor potential ADEs were associated with unlicensed use of medicines or high alert status drugs. The FMEA study identified 72 potential failures in the NICU medication use process with 193 associated causes and effects. Multiple failures were possible in the process of �prescribing medication� and in the process of �preparation of medication for administration�. The highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Conclusions. Analysis of the risk factors of ADEs and potential ADEs found that the most vulnerable processes were when prescribing and when preparing a medicine for administration; especially when involving narcotic and antibacterial agents and for children with greater medication exposure Strategies that selectively target these high risk areas are therefore likely to have the greatest impact on preventing drug-related injuries in hospitalised children.

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Jarernsiripornkul, Narumol. "Pharmacist input into patients' self-reporting of adverse drug reactions." Thesis, Robert Gordon University, 1999. http://hdl.handle.net/10059/2717.

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Adverse drug reactions (ADRs) are common and should be reported to the CSM, particularly for newly marketed drugs. There is under-reporting of ADRs by doctors. Involving the patient in self-reporting, particularly when initiated by pharmacists is feasible and could help to improve reporting rates. This study investigated a comprehensive checklist questionnaire listed symptoms in all body systems to facilitate patient self-reporting using both established and new 'black triangle' centrally-acting drugs. Symptoms reported were compared to their documentation in medical notes and for new drugs to reports from other sources. A novel classification system for ADRs was developed to take account of the minimal data available and used to evaluate the potential accuracy of symptom attribution by patients. An external comparison of a sample of symptom classifications by an ADR expert was also obtained. The questionnaire was sent to 464 patients prescribed carbamazepine, sodium valproate, trazodone, doxepin and co-proxamol from three participating medical practices in a pilot study. Subsequently, it was sent to all patients (n=2307) prescribed tramadol, fentanyl patch, venlafaxine, nefazodone, citalopram, moclobemide, gabapentin, lamotrigine and topiramate from 79 participating medical practices in Grampian during January-March 1997. The overall response rates were 44.6% (n=207) for the pilot study and 36.3% (n=837) for the main study. The most frequently reported symptoms were: drowsiness for carbamazepine, unusual tiredness for sodium valproate, constipation for co-proxamol, dry mouth for trazodone, doxepin, tramadol, venlafaxine, nefazodone, moclobemide and citalopram, weight gain for gabapentin, loss of memory for lamotrigine, weight loss for topiramate and constipation for fentanyl patch. Overall only 22.4% (522/2330) of symptoms reported by patients were recorded by GPs in the 310 medical notes accessed. In general, common symptoms were reported more frequently by patients than in CSM reports and PEM data. Patients tended to report minor and known ADRs which bothered them, while CSM and PEM reports received were of more severe ADRs. Respondents were more likely to report symptoms (6040/8630,70%) potentially caused by the study drugs than those not to be caused by the study drugs. Moderate agreement (Kappa = 0.4-0.5) was found between expert and researcher classifications of symptom causality. It is suggested that interpretation by pharmacists of patient self-reporting using the checklist questionnaire could result in much higher ADR reporting rates, in particular for new drugs.

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Ng, Fook-hong, and 吳福康. "Management of adverse gastrointestinal events in patients with anti-platelet therapy." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2008. http://hub.hku.hk/bib/B41290963.

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Gyenes, Gábor. "Cardiac side-effects of adjuvant radiotherapy for early breast cancer /." [Budapest] ; Stockholm, 1997. http://diss.kib.ki.se/1997/963-9106-04-6.

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Björn, Inger. "Hormone replacement therapy and effects on mood." Doctoral thesis, Umeå universitet, Obstetrik och gynekologi, 2003. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-94115.

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Background: During the past 5 decades, hormone replacement therapy (HRT) has been used, and appreciated for its beneficial effects, by millions of women in their menopause. As treatment for climacteric symptoms, estrogen is outstanding, and effects on hot flushes, vaginal dryness, and insomnia have been widely documented. The increased risks of venous thrombosis and breast cancer, however, restrict the use of estrogen. Estrogen treatment in women with a remaining uterus includes a progestin, added to protect the endometrium from hyperplasia and malignancies. The long-standing clinical impression, that progestin addition negatively influences mood, has been discussed in previous studies. Mood deterioration is, however, not mortal, although mood is important to the wellbeing and daily functioning of women treated with hormones. Studies of the mental side effects of HRT add to our understanding of steroid effects in the brain. Aims and methods: In our studies, we aimed to establish to what extent negative side effects cause women to discontinue HRT, and find out which drug compounds lead to mood deterioration. The questions asked were whether the type and dose of progestin and the estrogen dose during the progestin addition influence the mood and physical symptoms during sequential HRT. Compliance with HRT and reasons for discontinuing the therapy were evaluated in a retrospective longitudinal follow-up study. Treatment effects were studied in three randomized, double-blind, cross-over trials. During continuous estrogen treatment, effects of sequential addition of a progestin were studied by comparing two different progestins, medroxyprogesterone acetate (MPA) andnorethisterone acetate (NETA), comparing different doses of the same progestin, MPA, and comparing two doses of estrogen during addition of the same dose of MPA. The main outcome measure was the daily rating on mood and physical symptoms kept by the participants throughout the studies. The clinical trials were carried out at three gynecological centers in northern Sweden. Results and conclusions: Besides fear of cancer and a wish to determine whether climacteric symptoms had meanwhile disappeared, negative side effects was the most common reason or discontinuing HRT. Tension in the breasts, weight gain, a depressed mood, abdominal bloating, and irritability were the most important side effects seen both in women who continued HRT and in women who had discontinued the therapy. In our clinical trials, we showed that addition of a progestin to estrogen treatment induces cyclic mood swings characterized by tension, irritability, and depression, as well as increased breast tension, bloatedness, and hot flushes. Women with a history of premenstrual syndrome (PMS) appeared to be more sensitive to the progestin addition and responded with lower mood scores compared with women without previous PMS. In our studies, MPA provoked depressed mood to a lesser extent than did NETA. Surprisingly, the higher dose of MPA (20 mg) enhanced the mood, compared with 10 mg, when added to estrogen treatment. In women continuously treated with 3 mg estradiol, mood and physical symptoms worsened during the progestin addition, as compared with treatment with 2 mg estradiol. The negative side effects seen during sequential HRT have much in common with symptoms seen in the premenstrual dysphoric disorder (PMDD), which is a psychoneuroendocrine disorder with psychiatric expression. Explanations for treatment effects on mood are likely to be found in drug interactions with neurotransmitter systems of the brain.

Diss. (sammanfattning) Umeå : Umeå universitet, 2003

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O'Brien, Michelle University of Ballarat. "A study of multiple perspectives and knowledge in adverse drug reaction decision-making : Volume 1." University of Ballarat, 2004. http://archimedes.ballarat.edu.au:8080/vital/access/HandleResolver/1959.17/12769.

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Injury and illness associated with drugs are major problems in Australia and around the world, despite significant developments in the area of adverse drug reaction (ADR) decision support technology. The aims of this thesis are: to investigate the ADR decision domain; to determine factors that may assist in the prevention, detection and management of ADRs; and, to inform the pre-requirements analysis phase of the development of decision support systems. An approach has been taken that permits open and grounded study of the decision environment. This approach can then be used to frame and inform the design of an ADR decision support system. Fifteen case studies that comprise self selected consumers, the treating medical practitioner/s and expert perspectives of a single instance of an ADR (fifteen in-depth consumer interviews, eight in-depth medical practitioner interviews and 30 expert written questionnaires), have been collected and analysed using a grounded theory approach, a symbolic interactionist theoretical framework and a social constructionist epistemology. The analysis was performed from three perspectives: individual case study analysis (all interviews for an instance of an ADR); group analysis (consumer, medical practitioner and expert views) and analysis combining the individual case studies and groups of data. Concepts, themes and theory have emerged from these data in the following areas: • the contribution of the differences in understanding of the core concepts within this domain, to misunderstandings between decision-makers; • the consumer as a diagnostic decision-maker in the ADR decision domain; • differential diagnostic strategies used by the consumers and medical practitioners; • complexities in the ADR decision domain that make diagnosis difficult; • the role of ADR information in consumer and medical practitioner decision-making; • decision types used by consumers and medical practitioners in the ADR decision domain; • resources used by consumers, medical practitioners and experts to inform their ADR decisions; • decision-making with partial knowledge of the consumer case history, drug behaviour and diseases; • the impact of suspected ADRs on consumers and on future decision-making; • medical practitioner/consumer decision-making models; and, • reasons for low ADR reporting and the impact on the development of new ADR knowledge. The results above suggest the following: • The ADR decision domain is more complex than the current ADR decision support focus and that broadening this focus may assist in providing a more complete and useful decision support solution. • Improving the prevention, detection and management of ADRs requires more than providing prescribers with up to date ADR information. Other important factors are sharing of information, awareness of the role of the consumer, a collaborative approach between the consumers and medical practitioners, and generation of new ADR knowledge. • A grounded theory analysis of case study data using the theoretical perspectives of social constructionism and symbolic interactionism provided insight into this domain from the perspectives of multiple decision-makers. This may be an approach that can be used by systems analysts to inform the requirements analysis phases of decision support within other domains. The results of this qualitative work are preliminary. Future work is required to confirm and expand these results.
Doctor of Philosophy

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O'Brien, Michelle. "A study of multiple perspectives and knowledge in adverse drug reaction decision-making : Volume 1." Thesis, University of Ballarat, 2004. http://researchonline.federation.edu.au/vital/access/HandleResolver/1959.17/36308.

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Injury and illness associated with drugs are major problems in Australia and around the world, despite significant developments in the area of adverse drug reaction (ADR) decision support technology. The aims of this thesis are: to investigate the ADR decision domain; to determine factors that may assist in the prevention, detection and management of ADRs; and, to inform the pre-requirements analysis phase of the development of decision support systems. An approach has been taken that permits open and grounded study of the decision environment. This approach can then be used to frame and inform the design of an ADR decision support system. Fifteen case studies that comprise self selected consumers, the treating medical practitioner/s and expert perspectives of a single instance of an ADR (fifteen in-depth consumer interviews, eight in-depth medical practitioner interviews and 30 expert written questionnaires), have been collected and analysed using a grounded theory approach, a symbolic interactionist theoretical framework and a social constructionist epistemology. The analysis was performed from three perspectives: individual case study analysis (all interviews for an instance of an ADR); group analysis (consumer, medical practitioner and expert views) and analysis combining the individual case studies and groups of data. Concepts, themes and theory have emerged from these data in the following areas: • the contribution of the differences in understanding of the core concepts within this domain, to misunderstandings between decision-makers; • the consumer as a diagnostic decision-maker in the ADR decision domain; • differential diagnostic strategies used by the consumers and medical practitioners; • complexities in the ADR decision domain that make diagnosis difficult; • the role of ADR information in consumer and medical practitioner decision-making; • decision types used by consumers and medical practitioners in the ADR decision domain; • resources used by consumers, medical practitioners and experts to inform their ADR decisions; • decision-making with partial knowledge of the consumer case history, drug behaviour and diseases; • the impact of suspected ADRs on consumers and on future decision-making; • medical practitioner/consumer decision-making models; and, • reasons for low ADR reporting and the impact on the development of new ADR knowledge. The results above suggest the following: • The ADR decision domain is more complex than the current ADR decision support focus and that broadening this focus may assist in providing a more complete and useful decision support solution. • Improving the prevention, detection and management of ADRs requires more than providing prescribers with up to date ADR information. Other important factors are sharing of information, awareness of the role of the consumer, a collaborative approach between the consumers and medical practitioners, and generation of new ADR knowledge. • A grounded theory analysis of case study data using the theoretical perspectives of social constructionism and symbolic interactionism provided insight into this domain from the perspectives of multiple decision-makers. This may be an approach that can be used by systems analysts to inform the requirements analysis phases of decision support within other domains. The results of this qualitative work are preliminary. Future work is required to confirm and expand these results.
Doctor of Philosophy

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O'Brien, Michelle. "A study of multiple perspectives and knowledge in adverse drug reaction decision-making : Volume 1." University of Ballarat, 2004. http://archimedes.ballarat.edu.au:8080/vital/access/HandleResolver/1959.17/14606.

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Injury and illness associated with drugs are major problems in Australia and around the world, despite significant developments in the area of adverse drug reaction (ADR) decision support technology. The aims of this thesis are: to investigate the ADR decision domain; to determine factors that may assist in the prevention, detection and management of ADRs; and, to inform the pre-requirements analysis phase of the development of decision support systems. An approach has been taken that permits open and grounded study of the decision environment. This approach can then be used to frame and inform the design of an ADR decision support system. Fifteen case studies that comprise self selected consumers, the treating medical practitioner/s and expert perspectives of a single instance of an ADR (fifteen in-depth consumer interviews, eight in-depth medical practitioner interviews and 30 expert written questionnaires), have been collected and analysed using a grounded theory approach, a symbolic interactionist theoretical framework and a social constructionist epistemology. The analysis was performed from three perspectives: individual case study analysis (all interviews for an instance of an ADR); group analysis (consumer, medical practitioner and expert views) and analysis combining the individual case studies and groups of data. Concepts, themes and theory have emerged from these data in the following areas: • the contribution of the differences in understanding of the core concepts within this domain, to misunderstandings between decision-makers; • the consumer as a diagnostic decision-maker in the ADR decision domain; • differential diagnostic strategies used by the consumers and medical practitioners; • complexities in the ADR decision domain that make diagnosis difficult; • the role of ADR information in consumer and medical practitioner decision-making; • decision types used by consumers and medical practitioners in the ADR decision domain; • resources used by consumers, medical practitioners and experts to inform their ADR decisions; • decision-making with partial knowledge of the consumer case history, drug behaviour and diseases; • the impact of suspected ADRs on consumers and on future decision-making; • medical practitioner/consumer decision-making models; and, • reasons for low ADR reporting and the impact on the development of new ADR knowledge. The results above suggest the following: • The ADR decision domain is more complex than the current ADR decision support focus and that broadening this focus may assist in providing a more complete and useful decision support solution. • Improving the prevention, detection and management of ADRs requires more than providing prescribers with up to date ADR information. Other important factors are sharing of information, awareness of the role of the consumer, a collaborative approach between the consumers and medical practitioners, and generation of new ADR knowledge. • A grounded theory analysis of case study data using the theoretical perspectives of social constructionism and symbolic interactionism provided insight into this domain from the perspectives of multiple decision-makers. This may be an approach that can be used by systems analysts to inform the requirements analysis phases of decision support within other domains. The results of this qualitative work are preliminary. Future work is required to confirm and expand these results.
Doctor of Philosophy

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Werner, Lucas. "Sex-differences in reported adverse side-effects caused by Deep Brain Stimulation therapy in the subthalamic nucleus." Thesis, Uppsala universitet, Institutionen för biologisk grundutbildning, 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-445646.

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Parkinson’s disease is a common neurological disease which will progressively damagedopaminergic neurons in the brain. Later stages of the disease will result in death of theneurons. The diagnosis is often made with respect to the motor symptoms, which includetremors, bradykinesia, and rigidity. In addition to motor symptoms, non-motor symptomsappear in many patients, such as cognitive changes and mood disorders. One method used totreat Parkinson’s disease is deep brain stimulation, where electric pulses are emitted to aspecific brain area. A common target is the subthalamic nucleus, which is part of the basalganglia. By using deep brain stimulation, the dose of other medications for Parkinson’sdisease can be lowered. However, the mechanisms of deep brain stimulation are not yetentirely known, and there have been many reports of adverse side-effects caused by thismethod, including depression and other types of mood changes. Even so, information of apossible sex distribution of these side-effects is still limited. Here, a qualitative essay wasmade where 16 articles describing reported side-effects in men and women were compared. Inaddition, unpublished data from optogenetic studies on male and female mice were analysedin order to examine putative sex-differences upon experimental brain stimulation strategies.The results from the optogenetics results did not show any statistically significant sexdifferences.In contrast, by comparing the selected articles in which results of deep brainstimulation treatment in patients were reported, some differences were found. First, it seemsthat women report more depressive-like symptoms than men. Second, while men also reportdepressions, they also report more aggressive behaviour upon the treatment. A preliminaryconclusion of this essay is therefore that certain sex-differences can be observed among theadverse side-effects reported upon deep brain stimulation in Parkinson´s disease. However,since the studied material was limited, more research is required to make firmer conclusions.

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Gouws, Stephanus Andries. "The impact of hospital surveillance programmes on the incidence of adverse drug reaction reporting in a South African teaching hospital." Master's thesis, University of Cape Town, 1989. http://hdl.handle.net/11427/27186.

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Post-marketing surveillance refers to any non-experimental or observational study, method, or monitoring strategy that is applied to obtain information on drug experience (primarily adverse) after a drug has been approved for clinical use. One of the major problems in post-marketing surveillance studies is the lack or under-reporting of drug experiences by health care professionals. This study was developed to describe the impact of three different prescription event monitoring programmes on the reporting of adverse drug reactions (ADR's) in the hospital situation. The intensive ADR monitoring programme and two voluntary ADR monitoring programmes which followed were conducted in the medical wards of an urban teaching and referral hospital. All patients admitted to the designated wards were monitored by a dedicated pharmacist in the intensive programme, ward pharmacists in the first voluntary programme and by medical and nursing staff in the second voluntary programme. The pharmacist monitored a cohort of patients prospectively in two medical wards for a period of three months. The patient's record was linked with any suspected ADR. All details, i.e. patient drug orders, characteristics and ADR description, were recorded and then reported. From 228 patients monitored, 25 cases have been reported. The impact of the intensive ADR monitoring programme was a reporting rate of 11 percent. Reports were received on ADR's of a particularly mild, common and pharmacologically predictable (type A) nature. The first voluntary ADR monitoring programme comprised the reporting of suspected AD R's and the recording of drug orders for the patients and the patient characteristics. The ward pharmacists monitored for suspected AD R's in all patients during their regular ward rounds. Six cases were reported in a population of 1506 patients monitored during the three months. The reports were mainly on moderate to severe suspected AD R's of pharmacologically unpredictable (type B) nature. The rate of reports received by the surveillance unit in this study was 4 reports per ward pharmacist per annum. The second voluntary ADR monitoring programme comprised the prospective monitoring of 1555 patients by medical and nursing staff during their stay at the designated medical wards during the three month period. Patients were monitored for any ADR and when an ADR was suspected, the patient characteristics and drug orders were recorded and reported to the surveillance unit. Ten cases were reported represented by six reports from doctors and four by sisters. The reporting rate was 2 reports per doctor in four years and 3 reports for each member of the nursing team in 5 years. Reports were mainly received on moderate to severe suspected ADR's of a pharmacologically unpredictable (type B) nature.

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Lutkajtis, Anna. "The dark side of Dharma: Why have adverse effects of meditation been ignored in contemporary Western secular contexts?" Thesis, The University of Sydney, 2018. http://hdl.handle.net/2123/20303.

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In contemporary Western society, meditation techniques that were previously taught within the context of Eastern religious traditions are now increasingly being practiced in secular settings. So-called ‘secular forms’ of meditation first came to mainstream public awareness in the early 1960s, when Hindu-inspired Transcendental Meditation (TM) gained popularity in the United States. In the 1970s, vipassana, a standardized residential 10-day meditation retreat undertaken in a secular format, also became popular among Westerners. More recently, ‘mindfulness’ meditation, a form of secular meditation derived from Theravada Buddhism, has found widespread use as both a therapeutic intervention and a mainstream self-help tool. ‘Meditation as self-help’ has become a booming commercial industry, and alongside these practices there now exists a variety of secular meditation courses, apps, podcasts and meditation-related wearable technologies. While the boundary between the secular and the religious is blurred, popular mainstream meditation techniques such as TM, vipassana and mindfulness are generally promoted as being derived from Eastern religions, but inherently non-religious, and suitable for a general audience. The popularity of secular meditation has been due in large part to its acceptance within the scientific community. Over the past forty years, thousands of research studies have been conducted suggesting that there are many psychological and physiological benefits associated with meditation. As a result, various meditation techniques have been incorporated into a number of therapeutic interventions and used as tools for the treatment of a variety of clinical issues. Interest in meditation has also grown as a result of mainstream media attention, particularly coverage of TM and mindfulness. The media has played a crucial role in driving public acceptance of meditation by positioning the practice as an inherently secular, side-effect free, therapeutic technique that is ‘good for everyone.’ Although the scientific studies and popular media coverage of secular meditation have been overwhelmingly positive, meditation has not gone without some criticism. In particular, a small but growing literature indicates there could be adverse effects associated with meditation practice, in both clinical and non-clinical settings. Close examination of the scientific literature reveals that even in early meditation research, adverse effects, including profound but de-stabilising insights, problematic spiritual emergencies, and the exacerbation of pre-existing mental health issues, were identified. In religious traditions, these types of difficulties associated with meditation are acknowledged, and are usually understood to be milestones on the path to enlightenment, the result of improper practice or due to individual differences. Additionally, in traditional contexts, meditation teachers are equipped to deal with complications that may arise. However, in a Western secular context, negative effects associated with meditation have largely been overlooked or ignored in both the academic literature and in the popular media. Why have meditation adverse effects been ignored in secular settings? This question is particularly relevant given the current popularity of secular meditation practices in a large variety of non-traditional settings including therapy, education and the workplace. If meditation has adverse effects, and these adverse effects are underreported, this has significant implications for the safe delivery of meditation practices in these settings, including the consideration of factors such as teacher competency, participant screening, ongoing monitoring and informed consent. This thesis argues that meditation adverse effects have been ignored in secular settings as a result of three factors related to the secularisation process: first, in contemporary Western society the goal of meditation has shifted from enlightenment to symptom relief and personal transformation, leading to the assumption that meditation is harmless and ‘good for everyone;’ second, secular meditation has been decontextualized and divorced from the religious literature and contemplative practitioners who could shed light on possible difficulties associated with meditation; and third, the image of meditation in popular media has been manipulated to fit contemporary market demands for a secular Westernised therapeutic technique that can be commodified. This thesis comprises an analysis of pop cultural sources and a close reading of clinical research sources regarding meditation in the modern West. This project incorporates data from a variety of meditation studies obtained from the scientific literature, including experimental studies, qualitative studies, unpublished PhD dissertations and case studies. It also considers ‘traditional’ religious sources on meditation, including stages of the path literature, Buddhist meditation manuals and spiritual autobiographies.

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Lutkajtis, Anna. "The dark side of Dharma: Why have adverse effects of meditation been ignored in contemporary Western secular contexts?" Thesis, The University of Sydney, 2018. http://hdl.handle.net/2123/20496.

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In contemporary Western society, meditation techniques that were previously taught within the context of Eastern religious traditions are now increasingly being practiced in secular settings. So-called ‘secular forms’ of meditation first came to mainstream public awareness in the early 1960s, when Hindu-inspired Transcendental Meditation (TM) gained popularity in the United States. In the 1970s, vipassana, a standardized residential 10-day meditation retreat undertaken in a secular format, also became popular among Westerners. More recently, ‘mindfulness’ meditation, a form of secular meditation derived from Theravada Buddhism, has found widespread use as both a therapeutic intervention and a mainstream self-help tool. ‘Meditation as self-help’ has become a booming commercial industry, and alongside these practices there now exists a variety of secular meditation courses, apps, podcasts and meditation-related wearable technologies. While the boundary between the secular and the religious is blurred, popular mainstream meditation techniques such as TM, vipassana and mindfulness are generally promoted as being derived from Eastern religions, but inherently non-religious, and suitable for a general audience. The popularity of secular meditation has been due in large part to its acceptance within the scientific community. Over the past forty years, thousands of research studies have been conducted suggesting that there are many psychological and physiological benefits associated with meditation. As a result, various meditation techniques have been incorporated into a number of therapeutic interventions and used as tools for the treatment of a variety of clinical issues. Interest in meditation has also grown as a result of mainstream media attention, particularly coverage of TM and mindfulness. The media has played a crucial role in driving public acceptance of meditation by positioning the practice as an inherently secular, side-effect free, therapeutic technique that is ‘good for everyone.’ Although the scientific studies and popular media coverage of secular meditation have been overwhelmingly positive, meditation has not gone without some criticism. In particular, a small but growing literature indicates there could be adverse effects associated with meditation practice, in both clinical and non-clinical settings. Close examination of the scientific literature reveals that even in early meditation research, adverse effects, including profound but de-stabilising insights, problematic spiritual emergencies, and the exacerbation of pre-existing mental health issues, were identified. In religious traditions, these types of difficulties associated with meditation are acknowledged, and are usually understood to be milestones on the path to enlightenment, the result of improper practice or due to individual differences. Additionally, in traditional contexts, meditation teachers are equipped to deal with complications that may arise. However, in a Western secular context, negative effects associated with meditation have largely been overlooked or ignored in both the academic literature and in the popular media. Why have meditation adverse effects been ignored in secular settings? This question is particularly relevant given the current popularity of secular meditation practices in a large variety of non-traditional settings including therapy, education and the workplace. If meditation has adverse effects, and these adverse effects are underreported, this has significant implications for the safe delivery of meditation practices in these settings, including the consideration of factors such as teacher competency, participant screening, ongoing monitoring and informed consent. This thesis argues that meditation adverse effects have been ignored in secular settings as a result of three factors related to the secularisation process: first, in contemporary Western society the goal of meditation has shifted from enlightenment to symptom relief and personal transformation, leading to the assumption that meditation is harmless and ‘good for everyone;’ second, secular meditation has been decontextualized and divorced from the religious literature and contemplative practitioners who could shed light on possible difficulties associated with meditation; and third, the image of meditation in popular media has been manipulated to fit contemporary market demands for a secular Westernised therapeutic technique that can be commodified. This thesis comprises an analysis of pop cultural sources and a close reading of clinical research sources regarding meditation in the modern West. This project incorporates data from a variety of meditation studies obtained from the scientific literature, including experimental studies, qualitative studies, unpublished PhD dissertations and case studies. It also considers ‘traditional’ religious sources on meditation, including stages of the path literature, Buddhist meditation manuals and spiritual autobiographies.

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Werner, Christoph. "The Development and Evaluation of a new Experimental Model of an Active Placebo to Investigate how the Experience of Side Effects Influences the Placebo Effects." Thesis, The University of Sydney, 2022. https://hdl.handle.net/2123/27394.

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Most conventional placebos have no perceptible features and therefore are not likely to mimic a real medication in a RCT or clinical practice. This means that using conventional placebos to understand the placebo effect might not accurately reflect the conditions under which placebo effects occur. This project sought to extend the research on active placebos by developing and evaluating a new experimental model of an active placebo to investigate how perceptible features of a placebo influences its effect. A systematic review and meta-analysis showed that adverse event rates differed statistically significantly between placebo groups of RCTs and that the adverse events experienced in the placebo groups statistically significantly correlated with the adverse events reported by the corresponding medications group. Study 1 demonstrated that the new active placebo model successfully elicited the target side, while being mostly well tolerated. Study 2 showed that most participants receiving a conventional placebo correctly guessed that they had been allocated to the placebo group, while active placebo participants were split evenly between indicating having received a placebo and active medication, suggesting differential blinding as a result of the active placebo. Results from Study 3 indicated no statistically significant effect of message framing on sleep following active placebo administration, nor an overall placebo effect. The findings from this thesis indicated no statistically significant placebo effect on sleep for either conventional or active placebo. Interestingly, however, the results indicate that active placebos can facilitate the maintenance of participant blinding in RCTs and that in such contexts, a lack of side effects might have diminished the placebo response. As such, the active placebo model developed here shed light on how side effects may influence outcomes in RCTs and could help inform the development of techniques to improve blinding in practice.

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16

Pierfederici, Andrea. "Eventi avversi nelle manipolazioni cervicali: revisione della letteratura." Bachelor's thesis, Alma Mater Studiorum - Università di Bologna, 2020.

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Introduzione: La manipolazione spinale cervicale è una tecnica di terapia manuale utilizzata per trattare problematiche muscoloscheletriche. Se da un lato ci sono evidenze che supportano l’efficacia terapeutica della tecnica, dall’altro ci sono dubbi per quanto riguarda la sicurezza del trattamento. Obiettivo: Valutare attraverso le evidenze scientifiche presenti in letteratura tutti gli eventi avversi, e la loro incidenza, correlati alla manipolazione del tratto cervicale nella popolazione adulta. Metodi: La ricerca per l'individuazione dei contributi scientifici è stata avviata, da febbraio a settembre del 2020, su tre database scientifici: PubMed, PEDro e Cochrane Library. Sono stati selezionati inizialmente solamente studi clinici randomizzati, e successivamente a causa dell’assenza di eventi avversi moderati/gravi, si è deciso di includere anche studi osservazionali. La qualità metodologica degli studi è stata stabilita attraverso la scala PEDro, per studi clinici randomizzati, e la Newcastle-Ottawa Scale, per studi osservazionali. Risultati: Sono risultati eleggibili quattro studi clinici randomizzati e due studi osservazionali. Dall’analisi degli articoli presi in considerazione emerge che se gli eventi avversi minori in seguito alla manipolazione cervicale sono relativamente comuni, invece il rischio di un evento moderato/grave è estremamente basso. Dagli studi osservazionali inclusi non emerge una correlazione significativa tra manipolazione cervicale e l’ictus vertebro-basilare, a differenza di altri presenti in letteratura. Conclusioni: Considerando la natura transitoria degli effetti collaterali minori e l’estrema rarità degli eventi avversi moderati/gravi, possiamo considerare la manipolazione spinale cervicale come un’opzione terapeutica con un rapporto beneficio-rischio “bilanciato”. Ulteriori studi sono necessari per potere raggiungere una maggiore consapevolezza sull’argomento degli eventi avversi più gravi.

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Humble, Mats B. "Obsessive-compulsive disorder, serotonin and oxytocin : treatment response and side effects." Doctoral thesis, Örebro universitet, Institutionen för medicinska vetenskaper, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-51438.

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Obsessive-compulsive disorder (OCD), with a prevalence of 1-2 %, frequently leads a chronic course. Persons with OCD are often reluctant to seek help and, if they do, their OCD is often missed. This is unfortunate, since active treatment may substantially improve social function and quality of life. Serotonin reuptake inhibitors (SRIs) have welldocumented efficacy in OCD, but delayed response may be problematic. Methods to predict response have been lacking. Because SRIs are effective, pathophysiological research on OCD has focussed on serotonin. However, no clear aberrations of serotonin have been found, thus other mechanisms ought to be involved. Our aims were to facilitate clinical detection and assessment of OCD, to search for biochemical correlates of response and side-effects in SRI treatment of OCD and to identify any possible involvement of oxytocin in the pathophysiology of OCD. In study I, we tested in 402 psychiatric out-patients the psychometric properties of a concise rating scale, “Brief Obsessive Compulsive Scale” (BOCS). BOCS was shown to be easy to use and have excellent discriminant validity in relation to other common psychiatric diagnoses. Studies II-V were based on 36 OCD patients from a randomised controlled trial of paroxetine, clomipramine or placebo. In study II, contrary to expectation, we found that the change (decrease) of serotonin in whole blood was most pronounced in non-responders to SRI. This is likely to reflect inflammatory influence on platelet turnover rather than serotonergic processes within the central nervous system. In studies IV-V, we found relations between changes of oxytocin in plasma and the anti-obsessive response, and between oxytocin and the SRI related delay of orgasm, respectively. In both cases, the relation to central oxytocinergic mechanisms is unclear. In males, delayed orgasm predicted anti-obsessive response.

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Riediger, Carina, Tibor Schuster, Kristian Barlinn, Sarah Maier, Jürgen Weitz, and Timo Siepmann. "Adverse Effects of Antidepressants for Chronic Pain: A Systematic Review and Meta-analysis." Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2017. http://nbn-resolving.de/urn:nbn:de:bsz:14-qucosa-230668.

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Background: Antidepressants are widely used in the treatment of chronic pain. Applied doses are lower than those needed to unfold an antidepressive effect. While efficacy of antidepressants for chronic pain has been reported in large randomized-controlled trials (RCT), there is inconsistent data on adverse effects and tolerability. We aimed at synthesizing data from RCT to explore adverse effect profiles and tolerability of antidepressants for treatment of chronic pain. Methods: Systematic literature research and meta-analyses were performed regarding side effects and safety of different antidepressants in the treatment of chronic pain according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The National Center for Biotechnology Information library and MEDLINE were searched. Randomized placebo-controlled trials were included in quantitative data synthesis. results: Out of 1,975 screened articles, 33 papers published between 1995 and 2015 were included in our review and 23 studies were included in the meta-analyses. A higher risk for adverse effects compared to placebo was observed in all antidepressants included in our analyses, except nortriptyline. The most prevalent adverse effects were dry mouth, dizziness, nausea, headache, and constipation. Amitriptyline, mirtazapine, desipramine, venlafaxine, fluoxetine, and nortriptyline showed the highest placebo effect-adjusted risk of adverse effects. Risk for withdrawal due to adverse effects was highest in desipramine (risk ratio: 4.09, 95%-confidence interval [1.31; 12.82]) followed by milnacipran, venlafaxine, and duloxetine. The most common adverse effects under treatment with antidepressants were dry mouth, dizziness, nausea, headache, and constipation followed by palpitations, sweating, and drowsiness. However, overall tolerability was high. Each antidepressant showed distinct risk profiles of adverse effects. conclusion: Our synthesized data analysis confirmed overall tolerability of low-dose antidepressants for the treatment of chronic pain and revealed drug specific risk profiles. This encompassing characterization of adverse effect profiles might be useful in defining multimodal treatment regimens for chronic pain which also consider patients’ comorbidities and co-medication.

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Jolivot, Pierre-Alain. "Latrogénie médicamenteuse et admissions en réanimation : investigation des principales causes." Thesis, Paris 6, 2016. http://www.theses.fr/2016PA066463/document.

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Les événements indésirables médicamenteux (EIM) regroupent à la fois les effets indésirables des médicaments (ADR : Adverse Drug Reactions), considérés comme non évitables et les erreurs médicamenteuses (EM), considérées comme évitables. L’objectif de cette thèse est d’étudier les EIM conduisant à une admission en réanimation.Dans un premier temps, nous avons effectué une revue systématique de la littérature portant sur l’incidence des hospitalisations en réanimation pour EIM. Au total, 11 études ont été intégrées. L’incidence des EIM nécessitant une admission en réanimation variait de 0,37 à 27,4 %. Au total, 17,5 à 85,7 % de ces EIM étaient jugés évitables. Nous avons mené dans un second temps une étude observationnelle d’une durée d’un an dans un service de réanimation médicale d’un hôpital universitaire. Cette étude avait pour objectif d’évaluer l’incidence, l’évitabilité, la sévérité, le coût des EIM responsables d’admissions en réanimation et d’identifier les causes amorces à l’origine des EM.Au total, 743 séjours ont été inclus dont 102 (13,7 %) étaient liés à une EM et 71 (9,6 %) à un ADR. Le taux d’événements évitables était ainsi de 0,59. La non-observance des patients à leur traitement médicamenteux était la principale cause amorce des EM (n = 31/102). Les 102 séjours évitables liés à une EM représentaient un total de 528 journées d’hospitalisation en réanimation, occupant ainsi en moyenne 1,4 lit par jour sur une période d’un an pour un coût total de 747 651 €.Ce travail conclue sur la nécessité d’effectuer des études complémentaires afin d’évaluer les moyens à mettre en œuvre pour réduire l’incidence des EIM responsables d’admissions en réanimation
Adverse drug events (ADE) include adverse drug reactions (ADR), considered as not preventable and medication errors (ME), considered as preventable. The aim of this thesis is to describe ADE responsible for ICU admissions. First, we conducted a systematic review dealing with the incidence of ADE requiring ICU admission in adult patients. A total of 11 studies were included in the meta-analysis. The reported incidences of ADE requiring ICU admission ranged from 0.37 to 27.4%. Preventable events accounted for 17.5 to 85.7% of the events.To get more insight into this topic and to complete the published data, we performed a one-year observational study in a medical ICU of a teaching parisian hospital. The objectives of the study were to estimate the incidence of ICU admissions due to ADE, to assess preventability, severity and costs of these ADE and to determine the leading causes of medication errors (preventable ADE). A total of 743 admissions were included with 102 stays (13.7%) related to ME and 71 (9.6%) related to ADR. Medication non-compliance was the main leading cause of ME (n = 31/102). The 102 medication error-related admissions accounted for a total of 528 days of hospitalization in the ICU, requiring a mean of 1.4 ICU beds per day over the one-year period, with an associated total cost amounting to 747,651 €.This work concludes that further studies should be performed to assess ways to reduce the incidence of ADE responsible for ICU admissions

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Fabretti, Sandra de Carvalho. "Busca ativa de eventos adversos a medicamentos em recém-nascidos hospitalizados." Universidade de São Paulo, 2016. http://www.teses.usp.br/teses/disponiveis/6/6135/tde-20122016-122613/.

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Introdução - Os recém-nascidos são considerados vulneráveis a eventos adversos a medicamentos pela imaturidade fisiológica, pela necessidade de se considerar as proporções corporais ao determinar dosagens de fármacos, pelas limitações práticas durante a administração medicamentosa e pela alta proporção de medicamentos utilizados para o seu tratamento quando em cuidados hospitalares. Além disso, a população de recém-nascidos geralmente não é incluída nos estudos clínicos de utilização de medicamentos. Neste contexto, a terapêutica farmacológica em recémnascidos termina na extrapolação das informações que levam à aprovação do registro de medicamentos para uso em adultos ou em crianças mais velhas. Apesar da relevância do tema, a identificação dos eventos adversos relacionados a medicamentos em hospitais ainda é realizada por meio da notificação voluntária. Estima-se que este método detecte apenas de 5 a 10 por cento dos eventos adversos por medicamentos ocorridos em uma instituição de cuidado à saúde. Uma ferramenta conhecida como trigger foi demonstrada como uma técnica mais efetiva em relação ao convencional sistema de notificação voluntária em pacientes hospitalizados. Um trigger é definido como um rastreador encontrado a partir da revisão de prontuários de pacientes, permitindo selecionar os registros nos prontuários os quais existe maior probabilidade de ter ocorrido um evento adverso a medicamento. Objetivo - Utilizar rastreadores para a identificação de eventos adversos a medicamentos (EAM) em recém-nascidos hospitalizados. Métodos Trata-se de um estudo de coorte prospectivo observacional. A pesquisa foi realizada no Hospital Universitário da Universidade de São Paulo, nas unidades de cuidados intermediários neonatal convencional e terapia intensiva neonatal, durante o período de março a setembro de 2015. Foram incluídos os recém-nascidos hospitalizados que utilizaram medicamentos durante a internação. Uma lista de rastreadores foi desenvolvida para ser utilizada na identificação de EAM nesta população. Os prontuários dos recémnascidos eram avaliados, a fim de detectar primeiramente a existência de um rastreador. Se o rastreador fosse encontrado, era registrado e seguia-se com uma revisão mais detalhada à procura de possíveis EAM relacionados. Os recém-nascidos foram acompanhados até a sua alta ou até completarem 29 dias de vida. O desempenho de cada um dos rastreadores para identificar EAM foi calculado. As frequências dos EAM foram determinadas. As características dos eventos adversos e dos medicamentos relacionados foram descritas. Resultados O estudo incluiu 125 recém-nascidos. Foram encontrados 925 rastreadores, que foram positivos 208 vezes para identificar suspeitas de eventos adversos a medicamentos e que corresponderam ao número final de 115 EAM. A taxa de rendimento geral dos rastreadores foi 22,5 por cento. A incidência geral de EAM foi 46,4 por cento (IC 37,6; 55,1). A taxa geral de EAM por 1000 pacientes-dia foi 81,6 (IC 67,4; 98,0). Os EAM mais frequentes foram: diarreia (29,6 por cento), vômito (23,5 por cento), hipersedação (7,0 por cento) e hiperglicemia (5,2 por cento). Os medicamentos mais frequentes associados aos EAM foram: antibióticos (39,4 por cento), analgésicos (13 por cento), vitaminas (12,5 por cento), cafeína (11,1 por cento) e psicolépticos (8,7 por cento). Entre os rastreadores de alto desempenho destacam-se: hipersedação, prescrição de metadona/lorazepam e prescrição de flumazenil. Estes rastreadores identificaram EAM relacionados aos analgésicos e psicolépticos, duas das classes terapêuticas mais implicadas em EAM neste estudo. Conclusões - Os EAM mais frequentes identificados pelos rastreadores foram: diarreia, vômito, hipersedação e hiperglicemia. Os medicamentos mais frequentes associados a EAM foram: antibióticos, analgésicos, vitaminas, cafeína e psicolépticos. A incidência geral de EAM de 46,4 por cento e a taxa de incidência foi 81,6 EAM por 1000 pacientes-dia. A busca ativa de EAM por rastreadores permite uma análise focada de elementos específicos nos prontuários de pacientes. Este tipo de pesquisa permite a identificação de um maior número de EAM que podem passar despercebidos em simples revisão de prontuários.
Introduction - Newborns are considered vulnerable to adverse drug events because of their physiological immaturity, to consider the body proportions to determine dosages of drugs, the practical limitations during drug administration and the high proportion of drugs used for their treatment while in hospital care. Furthermore, the population of newborns is usually not included in clinical trials for the approval of new drugs. In this context, drug therapy in children is based on extrapolation of information that lead to the approval of the drug for use in adults or in older children. Despite the relevance of the subject, the identification of adverse drug events in hospitals is still carried out through voluntary reporting. It is estimated that this method detects only 5 to 10 per cent of the adverse events occurred by medications in a health care institution. A tool known as \"trigger\" is shown as a superior method compared to the conventional voluntary reporting system in hospitalized patients. A \"trigger\" is defined as a \"flag\" found from the patient chart review, allowing to select the records in the charts that are most likely to have experienced an adverse drug event. Aim - Use triggers to identify adverse drug events (ADE) in hospitalized newborns. Methodology - This is an observational prospective cohort study. The study was conducted at the University Hospital of the University of São Paulo, in the neonatal conventional intermediate care unit and in the neonatal intensive care unit, from March to September 2015. Hospitalized newborns were included using medications during hospitalization. A trigger list was made to identify ADE in this population. The triggers on this list were actively sought in medical charts of newborns. If a trigger was found, it was registered and followed up with a more detailed search for potential ADEs that occurred. Newborns were followed until their discharge or until completing 29 days of life. The performance of each trigger to identify ADE was calculated. The frequencies of ADE were determined. The characteristics of adverse events and related drugs have been described. Results - The study included 125 newborns. 925 triggers were found, which were positive 208 times to identify suspected ADE. That corresponded to the final number of 115 ADE. The overall triggers rate was 22.5 per cent . The overall incidence of ADE was 46.4 per cent (CI 37.6; 55.1). The overall frequency of ADEs per 1,000 patient-days was 81.6 (CI 67.4; 98.0). The most common ADE were diarrhea (29.6 per cent), vomiting (23.5 per cent), oversedation (7.0 per cent) and hyperglycemia (5.2 per cent). The most common medications associated with ADEs were antibiotics (39.4 per cent), analgesics (13 per cent), vitamins (12.5 per cent), caffeine (11.1 per cent) and psycholeptics (8.7 per cent). Among the highperformance trigger, it stand out: \"oversedation,\" \"prescription of methadone / lorazepam\" and \"prescription of flumazenil.\" These triggers identified ADE related to analgesics and psycholeptics, two of the therapeutic classes more involved in ADE in this study. Conclusions Frequent EAM identified by triggers were diarrhea , vomiting, hyperglycemia and oversedation . The most common medications associated with ADE were antibiotics, analgesics, vitamins, caffeine and psycholeptics. The overall incidence of EAM 46.4 per cent and the incidence rate was 81.6 EAM per 1000 patient-days. The active search for ADE by triggers allows a focused review of specific elements in the patient records. This kind of search allows the identification of a greater number of ADE that could go unnoticed in simple review of medical records.

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Batra, Sonia. "The Impact of the Sentinel Initiative and FAERS Surveillance System on Consumer Safety." ScholarWorks, 2016. https://scholarworks.waldenu.edu/dissertations/2438.

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The U.S. Food and Drug Administration (FDA) uses the FDA Adverse Event Reporting System (FAERS) to monitor adverse events resulting from pharmaceutical drug use. However, this system has limitations such as not allowing real-time data collection. To address these limitations, the FDA launched the Sentinel Initiative in 2008. This comparative case study was conducted to describe perceptions of investigating the efficacy of the Sentinel Initiative compared with the FAERS. The study was based on the theory of preemption as it emphasized the need for efficient means for providing unquestionable proof that consumers suffered adverse drug effects. The sample included interivews of 20 individuals, who worked closely with the FAERS program and were familiar with the Sentinel Initiative. In-depth key-informant interviews had been conducted to determine the perceptions of the participants regarding the challenges and benefits of the Sentinel Initiative compared with FAERS. To analyze data, content analysis was used. The study concluded that the FAERS and Sentinel Initiative provided a systematic database, which included health data, that could be used to improve public health. Due to the FAERS and Sentinel Initiative, adverse effects of drugs will be recognized and the safety of the patients and the public will be prioritized. The findings of this study have potential social impact for positive change at the societal level, organizational level, and individual level in terms of overall safety of the drugs. Sentinel initiative at its present state complements the existing FAERS and leverage its benefits by connecting at a grass roots level patients to an organization level as well as stakeholders to make an impact in providing safer drugs on the market.

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Edvinsson, Dan. "Attention Deficit/Hyperactivity Disorder in Adults : Prevalence, Psychiatric Comorbidities and Long-term Outcome." Doctoral thesis, Uppsala universitet, Psykiatri, Akademiska sjukhuset, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-327892.

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Attention Deficit/Hyperactivity Disorder (ADHD) was originally thought to occur only in children, but is increasingly recognised as causing functional impairment also in adulthood. The overall aim of this thesis was to achieve a comprehensive understanding of ADHD in adulthood. A questionnaire based on the DSM-IV criteria of ADHD, reported childhood symptoms, reading and spelling problems, difficulties and suffering and general assessment of functioning (GAF) was distributed to three samples: the general population (GP), outpatient psychiatry (OPP) and female prison inmates. Symptoms consistent with ADHD were more than three times higher in the OPP sample than in the GP sample (6.6 versus 2.1%). ADHD symptoms and related problems occurred in 50% of the prison inmates. A cohort of 168 patients diagnosed with ADHD in adulthood was interviewed about current ADHD symptoms and psychiatric comorbidity on axis I and II. The lifetime prevalence of psychiatric comorbidity on axis I was 92% and current comorbidity, including autism spectrum disorders and Tourette’s syndrome, was 47%. The sex-specific pattern of the comorbid disor-ders was similar to that in the general population. Forty-six per cent of the patients endorsed the specific criteria for at least one personality disorder. After a mean follow-up of six years, there was remission of adult ADHD in about 30% of the patients, regardless of whether there was ongoing medication or not. There were no differences in function and quality of life, except for global general improvement, which was better in patients currently on medication. The most prevalent long-term side effects of pharmacological treatment with mainly stimulants were decreased appetite, dry mouth, anxiousness/restlessness and an increase in pulse frequency. The discontinuation rate was about 50%: 29% discontinued because of a perceived lack of effect, followed by elevated mood or hypomania (11%). No detectable evidence of tolerance and increased need for dosage over time was observed. To conclude, Symptoms of ADHD is highly overrepresented in OPP and in female inmates compared with the GP. Furthermore, adults diagnosed with ADHD have a high lifetime prevalence of psychiatric comorbidity. Long-term pharmacological treatment with stimulants is safe with relatively mild and tolerable adverse effects. Continued medication, however, is not related to remission.

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Mota, Daniel Marques. "Evolução e resultados do sistema de farmacovigilância do brasil." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2017. http://hdl.handle.net/10183/159285.

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Os sistemas de farmacovigilância fundamentam as decisões sobre segurança no uso de medicamentos regulamentados por autoridades de saúde. Estudá-los e propor estratégias de melhorias contribuem para fortalecer os sistemas de saúde, aperfeiçoando a qualidade da assistência à saúde e assegurando a segurança do paciente e coletividade. A Tese objetivou analisar a evolução e desempenho do sistema brasileiro de farmacovigilância, denominado de SINAF, e as notificações dos pacientes com suspeitas de reações adversas a medicamentos (RAMs) registradas no Notivisa-medicamento no período de 2008 a 2013 e propor uma lista-referência de códigos da CID-10 para vigilância de RAMs e intoxicações medicamentosas (IMs). A Tese compreende seis artigos científicos organizados para publicação. No primeiro, uma revisão de escopo apresentou uma perspectiva histórica para caracterizar a evolução do SINAF e lacunas identificadas no processo, como a ausência de comissão de farmacovigilância que atenda aos requisitos mínimos de um sistema de farmacovigilância propostos pela Organização Mundial da Saúde. Os artigos 2, 3 e 4 analisaram características relacionadas com o desempenho do SINAF. O artigo 2 revelou que não há preferência digital da idade na base de dados das notificações de eventos adversos a medicamentos (EAMs) do Notivisa-medicamento. Mediante uma análise comparativa, o artigo 3 mostrou diferenças entre o formulário para notificação de EAMs utilizado no SINAF e de outros doze países latinoamericanos (Argentina, Bolívia, Chile, Colômbia, Costa Rica, Cuba, Guatemala, México, Panamá, Peru, Uruguai e Venezuela), sobretudo na quantidade de variáveis para preenchimento, podendo contribuir com a subnotificação de casos. No artigo 4 – um estudo de avaliação de sistemas de vigilância de saúde pública –, revelou que o desempenho do Notivisa-medicamento foi considerado satisfatório para três atributos (flexibilidade, validade e erro preditivo positivo) e deficitário para a maioria deles (simplicidade, aceitabilidade, representatividade, completude, consistência, oportunidade e clareza metodológica). O artigo 5, mediante estudo descritivo e retrospectivo, encontrou uma taxa de notificação de RAMs de 22,8/ 1 milhão de habitantes/ano. Trata-se de taxa bastante inferior a países de alta renda como Nova Zelândia, Suécia, Austrália e Suíça que possuem mais de 300 notificações por milhão, como em relação a países de média renda, como a África do Sul, com taxa de 77 por milhão de habitantes. A população feminina (60,5%) prevaleceu no total de pacientes (26.554), assim como, a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de RAMs ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 pares de medicamento-reação adversa, onde prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). O estudo 6 propôs uma lista-referência com 691 códigos da CID-10, sendo 360 (52,1%) relacionados com RAMs e 331 (47,9%) com IMs. Um total de 511 (73,9%) códigos estão relacionados com casos de admissão hospitalar e/ou óbito. Os achados da Tese evidenciam a necessidade de mudanças em diferentes aspectos estudados do SINAF, como forma de contribuir na produção de informações completas, fidedignas e mais representativas sobre danos ocasionados por medicamentos comercializados no país.
The pharmacovigilance systems support the decisions on safety when using medications regulated by health authorities. Analyzing them and proposing improvement strategies are ways to make healthcare systems stronger, improving the quality of healthcare assistance, making sure the patient is safe and that the population is ensured. The dissertation was aimed at analyzing the evolution and performance of the Brazilian pharmacovigilance system, SINAF, and the notification of patients with suspected adverse drug reactions (ADRs) registered with the notification system NOTIVISA/medication from 2008 through 2013, as well as proposing a reference list of ICD-10 codes for surveillance of ADRs and intoxication due to medication (IDM). The dissertation is comprised of six scientific articles ready to be published. The first one, a scoping review, presents a historical perspective to demonstrate the development process of SINAF and the gaps identified during the process, such as the absence of a pharmacovigilance commission that complies with the minimum requirements of a pharmacovigilance system as proposed by World Health Organization. Articles 2, 3 and 4 presents an analysis of the performance-related characteristics of SINAF. Article 2 reveals that there is no digital age preference in the adverse drug events (ADEs) database belonging to NOTIVISA/medication. Using a comparative analysis, article 3 shows differences between the form for ADEs notification using SINAF and in other twelve Latin-American countries (Bolivia, Chile, Colombia, Costa Rica, Cuba, Guatemala, Mexico, Panama, Peru, Uruguay and Venezuela), highlighting the number of variables to complete, and it may collaborate with the sub-notification of cases. Article 4 – a study on the evaluation of public health surveillance systems over time – reveal that the performance of NOTIVISA/medication was considered satisfactory regarding three attributes (flexibility, validity and positive predictive error) and deficient regarding most of the others (simplicity, acceptability, representability, integrality, consistency, opportunity and methodological clarity). Article 5, by means of a descriptive and retrospective study, found an ADR notification rate of 22.8/million inhabitants/year. This is a much lower rate than in high income countries, such as New Zealand, Sweden, Australia and Switzerland, which have over 300 notifications per million, when compared against average income, such as South Africa, with a rate of 77/million inhabitants. Female population (60.5%) prevailed in the total number of patients (26,554), as well as white race/color (58.1%). Age was between 0 - 112 years old (median = 46 years). Almost 1/3 (32.5%) of the suspected ADRs occurred in vulnerable populations (elderly and children). 54,288 pairs of medication/adverse reactions were assessed. Severe adverse reactions prevailed (59.2%), and attention is drawn to those resulting in clinically important effect (83.1%). Study 6 proposes a reference list with 691 ICD-10 codes; 360 (52.1%) out of them are ADRs-related and 331 (47.9%) out of them are IDM. A total of 511 (73.9%) codes are related to cases of hospital admission and/or death. The dissertation findings prove the need of changes across different aspects in SINAF as a way to contribute to production of complete, reliable and representative information on damages caused by commercially available drugs in Brazil.

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Bertocchio, Jean-Philippe. "Activation du Récepteur Minéralocorticoïde vasculaire et néphrotoxicité de la ciclosporine." Thesis, Paris 6, 2015. http://www.theses.fr/2015PA066032/document.

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La ciclosporine est un traitement immunosuppresseur très utilisé : elle inhibe l'activation des lymphocytes T via la calcineurine. Sa néphrotoxicité limite son utilisation : la ciclosporine induit une augmentation de la vasoconstriction ainsi qu'une augmentation de la réponse des cellules musculaires lisses vasculaires (CMLV) aux agents vasoactifs. Le récepteur minéralocorticoïde (RM), au-delà de ses effets sur la réabsorption sodée, agit sur le tonus vasculaire en modulant la réponse des cellules (endothéliales et musculaires lisses) vasculaires aux agents vasoactifs. Notre hypothèse était que le RM pouvait participer à l'action vasoconstrictrice de la ciclosporine ; son inactivation pourrait limiter la néphrotoxicité de la ciclosporine. Deux modèles de souris ont été invalidés génétiquement pour le RM : dans les cellules endothéliales et les CMLV (KO-RM CMLV). Seules les souris KO-RM CMLV étaient protégées contre la néphrotoxicité de la ciclosporine. Ces effets impliquent une action sur le tonus vasculaire rénal. L'antagonisme pharmacologique du RM (par le canrénoate) administré per os confère la même protection. En revanche, la néphrotoxicité induite par le tacrolimus (une autre anticalcineurine) n'est pas prévenue par l'antagonisme du RM. Utiliser un antagoniste sélectif du RM (l'éplérénone) pourrait prévenir la néphrotoxicité de la ciclosporine. Nous avons prouvé sa bonne tolérance en association à la ciclosporine chez les patients transplantés et insuffisants rénaux chroniques. Une kaliémie supérieure à 4,35mmol/L à l'initiation indique un sur-risque de développer une hyperkaliémie. L'efficacité reste à démontrer au cours d'un essai prospectif et randomisé
Cyclosporine A (cyclo) is a widely used drug in kidney transplantation: its anticalcineurin actioninhibits T lymphocytes activation and prevents allograft rejection. Despite a huge benefit on graftsurvival, cyclo exerts a side effect that limits its use: nephrotoxicity. Vasculotoxicity appears to becentral: cyclo enhances renal vasoconstriction by altering vasoactive factors and vascular smoothmuscle cells (VSMC) response to vasoactive factors. Beyond its effects on sodium reabsorption,Mineralocorticoid Receptor (MR) acts on vascular tone by modulating both endothelial and VSMCresponses to vasoactive factors. Our working hypothesis was that MR could participate to cycloinducedvasoconstriction and that MR inactivating (pharmacologically or genetically) could alleviatecyclo-induced nephrotoxicity. Two genetically MR-knock out (MR-KO) were generated: inendothelial or VSMC. Only VSMC MR-KO mice were protected from cyclo-induced nephrotoxicity.We also show that such an effect was mediated by vascular tone modulation. This prevention was alsoconferred by the systemic pharmacological antagonism of MR (by canrenoate) in mice but not duringnephrotoxicity induced by tacrolimus (another anticalcineurine drug used in kidney transplantation).Then, we proposed to use MR pharmacological antagonism in humans (by eplerenone) during kidneytransplantation. We first had to prove its safety in such a population. Among 31 cyclo-treated patients,only 9 developed hyperkalemia (>5mmol/L) and none presented serious side effect. We propose akalemia higher than 4.35mmol/L at baseline to be the marker of a higher risk of developinghyperkalemia under treatment. The efficiency of eplerenone to prevent/alleviate cyclo-inducednephrotoxicity during kidney transplantation should be tested during a randomized controlled trial

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Nascimento, Lais Cardoso do. "Custos decorrentes de eventos adversos a medicamento em pacientes hospitalizados." Universidade Federal de Goiás, 2018. http://repositorio.bc.ufg.br/tede/handle/tede/8458.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES
Theoretical Background: The adverse drug event (ADE) may occur due to adverse reaction and medication error. Damage caused by adverse events (AD) can lead to increased hospitalization time, rehospitalization, greater morbidity, the need for diagnostic and therapeutic interventions, irreversible consequences such as death and great economic impact. Objective: This study aims to analyze the costs of adverse drug events in hospitalized patients. Methods: This is a retrospective study carried out in a public hospital in the state of Goiás, Brazil, with patients admitted to the adult hospitalization clinics in the year 2016 and who suffered ADE. The colection of data occurred between May and October 2017. The data were collected through a nursing record and patient records. Additional hospitalization time, hours worked by the health professional, therapeutic and diagnostic procedures, and resources used by these users related to ADE were analyzed. In case of death, the average annual salary was calculated by the years of lost work lives for the society. The costs of the materials were obtained through a bidding system and the cost accounting unit of the hospital itself, the Federal Government Price Panel, and procedures through the SIGTAP Table. The data was typed in the Excel worksheet and analyzed by simple statistics. The present study was submitted and approved in the ethics committee with protocol in GEP / HC / UFG nº 030/2017 and was followed what is recommended by Resolution 466/2012. Results: We identified 164 cases of medication errors and adverse reactions in the nursing records. However, only the cases of patients in which the medical record was reported and that additional intervention were included in the study, which totaled 80 cases, 25 of which could have been avoided. The total costs due to EAM identified in the study were R $ 96,877.90. There were direct costs totaling R $ 26,463.90, of which R $ 20,430.36 was obtained from the hospital's perspective and R $ 6,033.54 from the SUS perspective. And of this amount R $ 14,380.13 was due to non-preventable EAM and R $ 12,083.77 due to preventable EAM. In the perspective of society, there were indirect costs of R $ 70,414.00, due to the death due to medication failure. Conclusion: It is concluded that the financial impact requires attention of managers, in the sense that avoiding such costs, it opens up possibilities for new investments.
Referencial Teórico: O evento adverso a medicamento (EAM) pode ocorrer devido à reação adversa e ao erro de medicação. Os danos causados pelos eventos adversos (EA) podem acarretar ao paciente o aumento do tempo de internação hospitalar, reinternação, maior morbidade, necessidade de intervenções diagnósticas e terapêuticas, consequências irreversíveis como a morte e grande impacto econômico. Objetivo: Este estudo tem por objetivo analisar os custos decorrentes de eventos adversos a medicamentos em pacientes hospitalizados. Métodos: Trata-se de um estudo retrospectivo, realizado em um hospital público do estado de Goiás com pacientes admitidos nas clínicas de internação adulto no ano de 2016 e que sofreram EAM. A coleta de dados ocorreu entre os meses maio e outubro de 2017. Os dados foram coletados através de caderno de registro de enfermagem e de prontuários dos pacientes. Foram analisados tempo adicional de internação, horas trabalhadas pelo profissional de saúde, procedimentos terapêuticos e diagnósticos, e recursos utilizados por esses usuários relacionados ao EAM. Em caso de óbito, foi calculado o salário médio anual pelos anos de vidas de trabalho para a sociedade perdidos. Os custos dos materiais foram obtidos através de um sistema de licitação e da unidade de contabilidade de custos do próprio hospital, do Painel de Preços do Governo Federal, e dos procedimentos através da Tabela SIGTAP. Os dados foram digitados na planilha Excel e analisados por estatística simples. O presente estudo foi submetido e aprovado no comitê de ética com protocolo na GEP/HC/UFG nº 030/2017 e foi seguido o que é preconizado pela Resolução 466/2012. Resultados: Foram identificados 164 casos de erros de medicação e de reação adversa nos registros de enfermagem. Porém fizeram parte do estudo apenas os casos de pacientes em que havia relato no prontuário e que foi feita intervenção adicional, o que totalizou em 80 casos, sendo que 25 desses incidentes poderiam ter sido evitados. Os custos totais devido a EAM identificado no estudo foram de R$ 96.877,90. Houveram custos diretos que se totalizaram em R$ 26.463,90, tendo R$ 20.430,36 obtidos pela perspectiva do hospital e R$ 6.033,54 pela perspectiva do SUS. E desse montante R$ 14.380,13 foi devido a EAM não evitáveis e R$ 12.083,77 devido a EAM evitáveis. Na perspectiva da sociedade, houve custos indiretos de R$ 70.414,00, devido ao óbito por falhas de medicação. Conclusão: Conclui-se que o impacto financeiro requer atenção dos gestores, no sentido de que evitando tais custos, abre-se possibilidades a novos investimentos.

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Gois, Pedro Henrique França. "Administração de tenofovir em ratas Wistar durante a gestação: efeitos na prole." Universidade de São Paulo, 2014. http://www.teses.usp.br/teses/disponiveis/5/5148/tde-13012015-123617/.

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Introdução: Tenofovir disoproxil fumarate (TDF) é um inibidor da transcriptase reversa análogo nucleotídeo que tem sido usado por gestantes para o tratamento da infecção pelo vírus da imunodeficiência humana (HIV), bem como para a prevenção da transmissão vertical do vírus. Até o momento, não há estudos experimentais ou em humanos sobre a incidência de alterações renais nos fetos expostos a esquemas contendo TDF. Objetivo: Verificar a ocorrência de alterações renais e sistêmicas fetais causadas pelo uso do TDF durante a gestação. Metodologia: Ratos Wistar fêmeas receberam dieta padrão com ou sem adição de TDF (100mg/Kg de dieta) desde uma semana antes do cruzamento até o parto. A prole proveniente do grupo TDF foi colocada com uma mãe adotiva não tratada durante o período de amamentação e foi comparada com a prole de ratas que receberam dieta padrão durante a gestação (grupo controle). Controle e TDF foram acompanhados até três (n=9 para cada grupo) e seis (n=12 e n=10, respectivamente) meses de idade. Foram avaliados: peso corporal (PC) e pressão arterial sistólica (PAS) mensais, contagem de glomérulos, função renal (através do clearance de inulina), parâmetros bioquímicos (proteinúria, colesterol total, sódio e potássio séricos e urinários), e expressão proteica do tecido renal para componentes do sistema renina angiotensina aldosterona (SRAA) e para transportadores de sódio. Resultados: A prole TDF apresentou menor PC ao nascimento em comparação com o controle. Após o 3º mês, o grupo TDF demonstrou um crescimento compensatório, atingindo o sexto mês com maior PC. O peso renal foi menor no grupo TDF, porém, não houve diferença do número de néfrons entre os grupos. O grupo TDF apresentou alterações estruturais glomerulares. Observou-se também um aumento progressivo da PAS após o segundo mês de idade no grupo TDF. Não houve diferença estatística na função renal entre os grupos. Os níveis plasmáticos de aldosterona foram mais elevados no grupo TDF, em associação com um aumento da expressão renal do SRAA. Ratos do grupo TDF apresentaram menor excreção renal de sódio e maior expressão renal de transportadores de sódio. Conclusões: Esta é a primeira descrição, a partir de um modelo experimental, que a utilização do TDF durante a gestação resulta em hiperativação do SRAA, aumento da expressão dos transportadores renais de sódio e hipertensão arterial da prole
Introduction: Tenofovir disoproxil fumarato (TDF) is a nucleotide reverse transcriptase inhibitor that has been used in pregnants for treatment of maternal HIV infection and for prevention of vertical transmission. Currently, there are no published studies providing data regarding the occurrence of renal abnormalities in fetuses exposed to TDF-containing regimens. Objective: To evaluate the occurrence of systemic and renal abnormalities in offspring of Wistar rats exposed to TDF during pregnancy. Methods: Female Wistar rats received a standard diet, with or without addition of TDF (100 mg/Kg diet), one week before mating and during pregnancy. Offspring from the TDF group were placed with an untreated foster mother during breastfeeding and compared with offspring from rats maintained on a standard diet during mating and pregnancy (control). Control and TDF were followed up at three and six months of age. Analyzed data: monthly body weight and systolic blood pressure (SBP), glomerular counting, renal function, biochemical parameters, and renal tissue immunoblotting for renin angiotensin aldosterone system (RAAS) and renal sodium transporters. Results: TDF offspring showed lower birth weight compared with the control group. After the third month, growth among the TDF group experienced a rapid catch-up. SBP increased progressively after the second month of age in the TDF group. The nephron number did not differ between groups. The TDF group showed glomerular structural changes. There was no significant difference in renal function between the groups studied. Plasma aldosterone was higher in the TDF group, associated with a significant increase in renal expression of RAAS. The TDF rats showed upregulation of renal sodium transporters and consequently lower urinary sodium excretion. Conclusions: This is the first demonstration using an experimental model that maternal exposure to TDF during gestation results in over activation of RAAS, upregulation of renal sodium transporters and hypertension of the offspring

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Hiraki, Patricia Yuko. "Estudo comparativo do uso de betabloqueador e corticosteroide oral no tratamento do hemangioma infantil." Universidade de São Paulo, 2017. http://www.teses.usp.br/teses/disponiveis/5/5132/tde-20022018-132655/.

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INTRODUÇÃO: Hemangioma Infantil (HI) é o tumor vascular mais comum da infância. Em 1992 a International Society for the Study of Vascular Anomalies (ISSVA) definiu o hemangioma infantil como tumor benigno de células endoteliais, com características clínicas, radiológicas e imuno-histoquímicas específicas. A origem do HI ainda é desconhecida. É sabido que apresentam potencial involutivo espontâneo e que o tratamento é indicado em 10% a 20% dos casos, podendo ter caráter emergencial ou eletivo. As indicações emergenciais compreendem situações de ameaça à função ou vida. As indicações eletivas são reservadas aos casos de hemangiomas localizados em áreas que podem levar à deformidade e/ou cicatriz permanente, quando apresentam complicações locais ou pequenas lesões em áreas expostas, podendo o tratamento ser clínico ou cirúrgico. A terapêutica medicamentosa tem sido a rotina e historicamente a opção mais utilizada foi o corticosteroide, cuja a eficácia é variável e os eventos adversos são frequentes. Em 2008 uma descoberta fortuita introduziu os betabloqueadores como nova opção para o tratamento do HI, com resultados estáveis e posteriores evidências clínicas do benefício da droga no tratamento do HI. Neste contexto, propôs-se avaliar o uso do propranolol, quantificando sua eficácia, segurança e incidência de eventos adversos, comparando-se ao uso da prednisolona (PRED). MÉTODO: Estudo intervencionista prospectivo randomizado com 50 portadores de HI, atendidos no complexo do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Os pacientes selecionados tinham idade inferior a 2 anos e indicação eletiva de tratamento. Os indivíduos incluídos foram aleatoriamente alocados em 2 grupos, sendo o primeiro grupo de tratamento com prednisolona e o outro de tratamento com propranolol (PROP), ambos por via oral, por 2 meses. Os pacientes foram seguidos semanalmente para mensuração de parâmetros clínicos incluindo peso, pressão arterial (PA), frequência cardíaca (FC) e saturação de oxigênio, além de avaliação objetiva da ocorrência de eventos adversos. A resposta ao tratamento foi avaliada de forma quantitativa por meio de medidas diretas da lesão e por 3 avaliadores independentes segundo critérios de melhora do aspecto clínico geral, volume, cor e envolvimento funcional. Os eventos adversos foram avaliados quanto a sua incidência e gravidade, utilizando-se a classificação do Common Terminology Criteria for Adverse Events. RESULTADOS: Vinte e seis pacientes foram alocados no grupo PRED e 24 no grupo PROP. Da casuística 37 indivíduos completaram as 8 semanas de seguimento. Em 8 casos houve interrupção precoce do tratamento em função de eventos adversos, em 1 caso por falha terapêutica e em 4 casos houve perda de seguimento. A idade média no grupo PRED foi de 6,46 meses e no grupo PROP de 7,25 meses. O gênero feminino foi predominante em ambos os grupos. A face foi a localização anatômica mais acometida, seguido do tronco. A resposta ao tratamento foi efetiva e sem distinção entre os grupos, com redução significativa das medidas avaliadas. Quanto as avaliações clínicas de acordo com o coeficiente de correlação interclasses, houve concordância interna excelente entre os avaliadores. As notas atribuídas para os pacientes mostraram melhora com o tratamento e no quesito cor mostrou-se diferença significativa em favor do grupo PROP. Quanto aos parâmetros clínicos mensurados, o percentil de peso mostrou elevação progressiva no grupo PRED sendo a diferença significativa em relação ao grupo PROP. A diferença nas medidas de PA sistólica entre os grupos foi significativa e a análise multivariável evidenciou uma elevação significativa no grupo PRED ao passo que no grupo PROP não houve alteração dos níveis pressóricos. A avaliação da FC revelou um significativo declínio no grupo PROP na 6º semana, não se mantendo no restante do período. Não foram identificadas alterações nas medidas de saturação de oxigênio. Quanto a incidência os eventos adversos (EA) a diferença entre os grupos foi significativa. No grupo PRED 22 pacientes apresentaram 35 EA sendo os mais frequentes o aspecto cushingoide, elevação da PA e infecções. No grupo PROP 10 pacientes apresentaram 10 EA incluindo hipotensão e distúrbios respiratórios. Quando a gravidade dos EA foi avaliada não foram observadas diferenças. CONCLUSÃO: Prednisolona e propranolol foram igualmente efetivos em reduzir o tumor. Considerando-se os eventos adversos, o uso do propranolol se mostrou como tratamento mais tolerável em relação ao uso do corticosteroide
INTRODUCTION: Infantile hemangioma (HI) is the most common vascular tumor of childhood. In 1992 the International Society for the Study of Vascular Anomalies (ISSVA) defined infantile hemangioma as a benign endothelial cell tumor with specific clinical, radiological and immunohistochemical characteristics. The origin of HI is still unknown. It is known that they have spontaneous involutive potential and that the treatment is indicated in 10% to 20% of the cases, and it can be emergency or elective. Emergency indications include life threatening situations. Elective indications are reserved for cases of hemangiomas located in areas that may lead to permanent deformity and/or scarring, when they present local complications or small lesions in exposed areas, and this treatment may be clinical or surgical. Drug therapy has been the routine and historically the most widely used option was the corticosteroid, whose efficacy is variable and the adverses events are frequent. In 2008 a fortuity finding introduced beta-blockers as a new option for HI treatment, with stable results and subsequent clinical evidence of drug benefit in the treatment of HI. In this context, it was proposed to evaluate the use of propranolol, quantifying its efficacy, safety and incidence of adverse events, compared to the use of prednisolone. METHODS: Prospective randomized interventional study with 50 patients with HI from the \"Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo\". The patients selected were younger than 2 years and had an elective indication of treatment. Patients included were randomly allocated into 2 groups, the first group being treated with predinisolone (PRED) and the other with propranolol (PROP), both orally, for 2 months. Patients were followed weekly to measure clinical parameters including weight, blood pressure (BP), heart rate (HR) and oxygen saturation, as well as an objective evaluation of the occurrence of adverse events. The response to treatment was quantitatively assessed by means of direct measures of the lesion and by 3 independent evaluators according to criteria of improvement of general clinical appearance, volume, color and functional involvement. Adverse events were evaluated for their incidence and severity, using the classification of the Common Terminology Criteria for Adverse Events. RESULTS: Twenty-six patients were allocated to the PRED group and 24 to the PROP group. Overall, 37 patients completed the 8-week follow-up. In 8 cases there was an early interruption of treatment due to adverse events, in 1 case due to therapeutic failure and in 4 cases there was loss of follow-up. The mean age in the PRED group was 6.46 months and in the PROP group of 7.25 months. The female gender was predominant in both groups. The face was the most affected anatomic location, followed by the trunk. The treatment response was effective and without distinction between groups, with a significant reduction of the measures evaluated. Regarding the clinical evaluations according to the interclass correlation coefficient, there was excellent internal agreement among the evaluators. The scores attributed to the patients showed improvement with the treatment and in the item color there was a significant difference in favor of the PROP group. Regarding the clinical parameters measured, weight percentile showed progressive elevation in the PRED group, presenting significant difference in relation to the PROP group. The difference in systolic BP measurements between groups was significant and multivariate analysis showed a significant increase in the PRED group, whereas in the PROP group there was no change in pressure levels. The HR evaluation revealed a significant decline in the PROP group in the 6th week, not remaining in the remainder of the period. No changes in oxygen saturation measurements were identified. Regarding the incidence and adverse events (AE), the difference between the groups was significant. In the PRED group 22 patients presented 35 AEs, the most frequent being cushingoid appearance, elevated BP and infections. In the PROP group 10 patients presented 10 AEs including hypotension and respiratory disorders. When the severity of AE was assessed, no differences were observed. CONCLUSION: Prednisolone and propranolol were equally effective in reducing the tumor. Considering the adverse events, the use of propranolol was shown as a more tolerable treatment in relation to corticosteroid use

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Azevedo, Maria Fernanda Salomão de. "Estudo da incidência e dos fatores de risco da nefrotoxicidade por vancomicina em um hospital terciário." Universidade de São Paulo, 2015. http://www.teses.usp.br/teses/disponiveis/5/5148/tde-09112015-112540/.

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Introdução: Vancomicina, considerada o antibiótico de primeira escolha para o tratamento de infecções estafilocócicas, é eliminada por filtração glomerular, e a sua administração deve ser individualizada de acordo com a função renal. As diretrizes atuais recomendam doses e níveis séricos maiores, para aumentar as chances de bons resultados clínicos. Questiona-se se esta estratégia causaria maior nefrotoxicidade. Objetivos: Comparar a frequência de injúria renal aguda (IRA) em pacientes com suspeita de infecção estafilocócica tratados com vancomicina ou com outros antimicrobianos com o mesmo perfil terapêutico em um hospital terciário. Analisar a associação do uso de vancomicina com o desenvolvimento de IRA nestes pacientes. Avaliar os fatores de risco associados ao desenvolvimento de IRA nos pacientes tratados com vancomicina. Identificar os fatores de risco associados à letalidade precoce e tardia nos pacientes com suspeita de infecção estafilocócica tratados com vancomicina ou outros antimicrobianos com o mesmo perfil terapêutico. Métodos: Foram analisados os prontuários dos pacientes com suspeita de infecção estafilocócica que receberam os antimicrobianos vancomicina, teicoplanina, oxacilina, daptomicina ou linezolida por pelo menos três dias nos anos de 2010 e 2011 em um hospital terciário. Analisou-se a frequência de IRA associada ao uso de vancomicina (critério KDIGO) e. por regressão logística, se o uso de vancomicina foi associado ao desenvolvimento de IRA. Avaliou-se por regressão logística os fatores de risco associados ao desenvolvimento de IRA no grupo de pacientes tratados com vancomicina. Analisou-se por regressão de Cox os fatores de risco para letalidades intra-hospitalar, seis meses e até um ano após a internação. Resultados: Foram incluídos 591 pacientes, dos quais 508 foram expostos à vancomicina e 83 foram expostos a teicoplanina, oxacilina, linezolida, ou daptomicina. IRA ocorreu em 28,5% dos pacientes que utilizaram vancomicina e em 14,5% dos que utilizaram outros antimicrobianos (p < 0,001). O grupo de pacientes tratados com vancomicina apresentou parâmetros sugestivos de maior gravidade, como maior frequência de culturas positivas para estafilococos, hipotensão grave, contagem de leucócitos em sangue periférico mais elevada e níveis séricos maiores de lactato, procalcitonina e PCR. Quando pacientes que desenvolveram IRA foram comparados com pacientes que mantiveram a função renal estável, observou-se que o uso de vancomicina, a duração do tratamento e nível sérico de vancomicina foram significativamente maiores entre os primeiros. Vancomicina foi identificada como fator independente para o desenvolvimento de IRA na regressão logística. Os fatores de riscos independentes para o desenvolvimento de IRA no grupo exposto à vancomicina foram uso de medicamentos nefrotóxicos ou que alteram a função renal, uso de medicamento vasopressor e concentração sérica de vancomicina >= 20 mg/L. Vancomicina não se associou a letalidade em nenhum dos períodos estudados, enquanto IRA se associou de forma independente à letalidade precoce e tardia. Conclusões: Estes resultados indicam que a vancomicina apresenta nefrotoxicidade significativa e que os seus níveis séricos devem ser obrigatoriamente avaliados. O uso de medicamentos nefrotóxicos ou que alteram a função renal deve ser, quando possível, evitado ou suspenso em pacientes tratados com vancomicina. O desenvolvimento de IRA, mas não o uso de vancomicina, foi fator independente para letalidade, reforçando que este antimicrobiano pode ser utilizado quando indicado, desde que se previna o desenvolvimento de IRA
Introduction: Vancomycin is considered the first choice antibiotic for treatment of staphylococcus infection. Vancomycin is eliminated through glomerular filtration, and so it is administration must be individualized according the renal function. Current treatment guidelines recommend higher doses and blood levels in order to increase the odds for an adequate clinical outcome. On the other hand, this strategy might cause higher vancomycin-associated nephrotoxicity. Objectives: To analyze the frequency of acute kidney injury (AKI) development in patients with suspicion of staphylococcus infection treated with vancomycin, or other antibiotics with the same therapeutic profile in a tertiary hospital. To analyze the association of vancomycin with AKI development in those patients. To analyze the risk factors for AKI development in vancomycin-treated patients. To identify the risk factors associated to early and late mortality in patients with suspicion of staphylococcus infection treated with vancomycin, or other antibiotics with the same therapeutic profile in a tertiary hospital.Methodology:We analyzed the files of all the patients with suspicion of staphylococcus infection treated with vancomycin, teicoplanin, oxacillin, daptomycin, or linezolid antibiotics for at least three days during the years of 2010 and 2011 in a tertiary hospital.The frequency of AKI development (KDIGO criteria) was assessed. Using logistic regression we assessed if vancomycin use was an independent risk factor for AKI development and the risk factors for AKI development in the group of patients treated with vancomycin. We assessed, using Cox regression, the risk factors for in-hospital, six months and one year after hospitalization mortality. Results: We included 591 patients in the final analysis, 508 using vancomycin and 83 using other antibiotics (teicoplanin, oxacillin, daptomycin, or linezolid). AKI developed in 28.5% of the vancomycin group compared with 14.5% in the other antibiotics group (p < 0.001). Patients treated with vancomycin showed parameters suggesting higher clinical severity, such as higher percent of staphylococcus positive cultures, severe hypotension, higher leukocytes blood count, higher serum levels of lactate, procalcitonin and CRP. When patients developing AKI were compared with patients maintaining preserved renal function, the first group showed a statistically significant higher frequency of vancomycin use, longer vancomycin treatment and higher vancomycin through levels. Using logistic regression vancomycin was identified as an independent risk factor for AKI development. The independent risk factors for AKI development in the vancomycin group were simultaneous use of vancomycin and other nephrotoxic drugs or drugs that influence renal function, vasopressor drugs use and blood levels of vancomycin >= 20 mg/L. Vancomycin was not associated with mortality in any studied time, whereas AKI was an independent risk factor for early and late mortality. Conclusions: These results indicate that vancomycin is associated with significative nephrotoxicity and that its blood levels must be mandatorily assessed. The use of drugs that are nephrotoxic or influence renal function must be, when feasible, avoided or halted in vancomycin-treated patients. AKI development, but not vancomycin use, was an independent risk factor for mortality, reinforcing the perception that vancomycin can be used when necessary, since AKI development is prevented

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Canale, Daniele. "Mecanismos de lesão renal em ratos com deficiência de vitamina D submetidos ao tratamento com Tenofovir." Universidade de São Paulo, 2014. http://www.teses.usp.br/teses/disponiveis/5/5148/tde-06062014-100748/.

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A Síndrome da Imunodeficiência Adquirida (AIDS) é um problema de saúde pública. O Tenofovir Disoproxil Fumarato (TDF) foi o primeiro inibidor do nucleotídeo da transcriptase reversa e é a droga mais recomendada para o tratamento da AIDS. Entretanto, o uso prolongado de TDF está associado com a nefrotoxicidade. A deficiência de vitamina D tem alta prevalência em indivíduos infectados com o Vírus da Imunodeficiência Humana (HIV). A vitamina D participa da regulação de atividades fisiológicas de diversos órgãos, incluindo o rim, oferecendo proteção contra as lesões ocasionadas por diferentes causas. Portanto, pacientes com níveis baixos de vitamina D infectados com o HIV podem apresentar complicações renais e cardiovasculares durante a terapia antirretroviral. Sendo assim, a carência desta vitamina pode acelerar a progressão da doença renal. Tendo em vista o aumento da incidência de hipovitaminose D na população mundial, esse trabalho tem o objetivo de verificar os mecanismos que levam ao desenvolvimento da lesão renal em ratos depletados de vitamina D submetidos ao tratamento com TDF. Ratos Wistar foram divididos em quatro grupos: controle, animais que receberam dieta padrão por 60 dias; dVD, animais que receberam dieta depletada em vitamina D por 60 dias; TDF, animais que receberam dieta padrão por 60 dias com a adição de TDF (50 mg/kg de dieta) nos últimos 30 dias; e dVD+TDF, animais que receberam dieta depletada em vitamina D por 60 dias com a adição de TDF nos últimos 30 dias. Ao final dos 60 dias, os animais foram submetidos à eutanásia, amostras de sangue, urina e o tecido renal foram coletados para a análise dos mecanismos de lesão renal. O tratamento com TDF levou a insuficiência renal observada pela queda da filtração glomerular e lesão tubular proximal com aparecimento de fosfatúria ocasionada pela diminuição do cotransportador sódio/fosfato subtipo IIa. Essas alterações foram acompanhadas de hipertensão e modificações no perfil lipídico. A deficiência em vitamina D associada à administração de TDF agravou os efeitos renovasculares e a nefrotoxicidade induzida pelo TDF, pelo menos em parte, devido ao aumento nos marcadores de estresse oxidativo e a participação do sistema renina-angiotensina-aldosterona. Portanto, é essencial monitorar os níveis de vitamina D em pacientes infectados com o HIV tratados com TDF
Acquired Immunodeficiency Syndrome (AIDS) has become one of the world\'s most serious health problem. Tenofovir Disoproxil Fumarate (TDF) was the first available nucleotidic reverse transcription inhibitor and is a widely prescribed antiretroviral medication for treatment of Human Immunodeficiency Virus (HIV). However, the long-term use of TDF has been associated with a number of toxicities, including those affecting the kidney. Vitamin D deficiency is prevalent among HIVinfected individuals. Vitamin D not only regulates numerous physiological activities of multiple organ systems, but also protects the kidney from injury from different causes. Thus, HIV-infected subjects with low levels of vitamin D could experience increased complications during antiretroviral therapy, such as cardiovascular disease and renal impairment. In view of the high worldwide incidence of hypovitaminosis D, the aim of this study was to investigate the effects of vitamin D deficiency on TDF-induced nephrotoxicity. Wistar rats were divided into four groups: control, receiving a standard diet for 60 days; dVD, receiving a vitamin D-free diet for 60 days; TDF, receiving a standard diet for 60 days with the addition of TDF (50 mg/kg food) for the last 30 days; and dVD+TDF receiving a vitamin D-free diet for 60 days with the addition of TDF for the last 30 days. At the end of the protocol, animals were euthanized and blood, urine and tissue samples were collected in order to evaluate the mechanisms responsible for renal injury. TDF led to impaired renal function, hyperphosphaturia, hypophosphatemia, hypertension and increased renal vascular resistance due to downregulation of the sodium-phosphorus cotransporter and upregulation of reninangiotensin- aldosterone system (RAAS). TDF also increased oxidative stress, as evidenced by higher TBARS and lower GSH levels, and induced dyslipidemia. Association of TDF and vitamin D deficiency aggravated renovascular effects and TDFinduced nephrotoxicity at least in part by the increase of oxidative stress and the involvement of RAAS. Hence, it is important to monitor vitamin D levels in HIV-infected patients treated with TDF

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Motter, Fabiane Raquel. "Desenvolvimento de critérios explícitos adaptados à realidade brasileira para avaliação do uso de medicamentos potencialmente inapropriados para idosos." Universidade do Vale do Rio dos Sinos, 2018. http://www.repositorio.jesuita.org.br/handle/UNISINOS/7150.

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CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
UNISINOS - Universidade do Vale do Rio dos Sinos
O uso de Medicamentos Potencialmente Inapropriados (MPIs) em idosos pode comprometer a efetividade ou a segurança da farmacoterapia e têm se destacado como importante desafio para saúde pública, visto que está associado a elevados índices de morbidade e mortalidade. Pesquisas nacionais que investigaram esse tema revelam que as prevalências de uso de MPIs variam de 28,0% a 82,6%; contudo, esses estudos utilizaram listas de MPIs validadas na América do Norte e Europa, uma vez que o primeiro consenso brasileiro sobre MPIs foi publicado somente no final de 2016. Segundo os autores, a lista desenvolvida apresenta algumas lacunas no conhecimento, uma vez que foi baseada em critérios publicados até 2012 e, portanto, não inclui as versões mais atualizadas publicadas em 2015, bem como não incorpora possíveis alternativas terapêuticas para os medicamentos que compõem a lista. Dessa forma, este estudo teve como objetivo estabelecer critérios explícitos para avaliação de MPIs prescritos aos idosos no Brasil e suas respetivas alternativas terapêuticas. O projeto englobou duas etapas complementares: 1- Elaboração da lista de critérios explícitos para avaliação de medicamentos inapropriados para idosos a partir de revisão sistemática já realizada; 2- Validação da proposta por consenso de especialistas utilizando técnica Delphi; A primeira etapa, elaboração da lista preliminar de MPIs, foi baseada em um estudo de revisão sistemática das listas publicadas entre janeiro/1991 e abril/2017.Realizou-se também uma análise qualitativa das listas com o objetivo de verificar a aplicabilidade destas ao mercado brasileiro em termos de disponibilidade e frequência de prescrição. Dessa forma, selecionaram-se três listas de MPIs: Beers 2015, STOPP 2015, European Union (7) PIM list. Ao final desse processo, obteve-se 153 critérios distribuídos em sete instrumentos: Dor e Inflamação, Sistema Cardiovascular, Sistema Endócrino, Geniturinário, Sistema Respiratório, Sistema Nervoso Central, sendo os dois primeiros já validados por meio da técnica Delphi modificada. Considerou-se validados os itens para os quais o limite inferior do IC 95% foi superior ou igual a 4,0. O consenso sobre MPIs - Dor e inflamação foi constituído duas rodadas. Um grupo de nove especialistas atingiu consenso sobre 98 (63,2%) das 155 questões apresentadas: 31/34 preocupações independente do diagnóstico, 4/4 preocupações quanto à dose, 4/4 preocupações quanto a duração do tratamento, 19/20 preocupações quanto ao uso em condições específicas, 12/23 considerações especiais de uso e 28/68 alternativas terapêuticas. No consenso sobre MPIs -Sistema Cardiovascular, um grupo de sete especialista atingiu consenso sobre 84 das 257 questões apresentadas: 20/25 preocupações independente do diagnóstico, 4/4 preocupações quanto à dose, 37/57 preocupações quanto ao uso em condições específicas, 20/105 considerações especiais de uso e 3/66 alternativas terapêuticas. Embora a validação de listas de MPIs a partir da opinião de especialistas seja um processo complexo, a listas desenvolvidas poderão ampliar o conhecimento sobre MPIs no país, uma vez que são baseadas em consensos recentes. Desse modo, esta pesquisa possibilitará um melhor entendimento da magnitude do uso de MPIs no Brasil, e poderá contribuir para o desenvolvimento de estratégias e intervenções mais eficazes para a redução dos problemas relacionados ao uso de medicamentos em idosos no país.
The use of potentially inappropriate medications (PIMs) for older patients is a public health problem because it can compromise the effectiveness or safety of pharmacotherapy and is responsible for high rates of morbidity and mortality in this age group. Brazilian studies that investigated PIMs show that the prevalence of PIM use ranges from 28.0% to 82.6%. However, these studies used PIM lists developed in other countries in North America and Europe. The first Brazilian consensus on PIMs was published in 2016. Limitations reported by the authors included that the PIM list was based on previous versions of Beers (2012) and STOPP (2008), therefore, it did not include the most up-to-date versions published in 2015, and did not incorporate therapeutic alternatives. The aim of the present study is to develop and validate explicit criteria for the evaluation of PIMs prescribed to older patients in Brazil and their respective therapeutic alternatives. The development of this project comprises of two steps: 1- Elaboration of the preliminary PIM list for older patients based on a systematic literature review; 2 - Validation of the preliminary PIM list with the consensus of experts using modified Delphi technique; The elaboration of the preliminary list of MPIs was based on a systematic review of PIM lists published between January 1991 and April 2017. A qualitative analysis of the PIM lists was performed with the objective of verifying their applicability to the Brazilian market. This way, three lists of PIMs were selected: Beers’ 2015, STOPP 2015, and European Union (7) PIM. Thus, we obtained 153 explicit criteria distributed across seven instruments: PIMs–Pain and Inflammation, PIMs–Cardiovascular System, PIMs–Endocrine System, PIMs–Genitourinary, PIMs–Respiratory System, and PIMs–Central Nervous System. The first two were already validated using the modified Delphi technique. The items for which the lower limit of the 95% confidence interval (CI) was greater than or equal to 4.0 were considered to have been validated. The consensus on PIMs–Pain and Inflammation was formed by two rounds. A group of nine experts reached consensus on 98 (63.2%) of the 155 items. A consensus was reached for 31/34 concerns regardless of diagnosis, 4/4 dose concerns, 4/4 concerns about the duration of treatment, 19/20 concerns about use under specific conditions, 12/23 special considerations of use, and 28/68 therapeutic alternatives. In the consensus on PIMs–Cardiovascular System, a group of seven experts reached consensus on 84 of the 257 questions. A consensus was reached for 20/25 concerns independent of diagnosis, 4/4 concerns regarding dose, 37/57 concerns regarding use under specific conditions, 20/105 special considerations of use and 3/66 therapeutic alternatives. Although the development and validation of PIM lists based on expert opinion is a long and complex process, the development of PIM list based on recent consensuses will expand the knowledge about the PIMs in Brazil. Thus, this research will improve the understanding of the magnitude of PIM use in this country, and may contribute to the development of more effective strategies and interventions to reduce drug-related problems among older Brazilian patients.

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Neto, José Dias Andrade. "Perfil de segurança do uso de polivinilpirrolidona-iodo tópico como agente de pleurodese no tratamento do derrame pleural neoplásico." Universidade de São Paulo, 2015. http://www.teses.usp.br/teses/disponiveis/5/5156/tde-01042015-120435/.

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INTRODUÇÃO: O polivinilpirrolidona-iodo (PVP-I) tópico vem sendo descrito como um agente esclerosante para pleurodese de fácil obtenção, baixo custo e com boa eficácia. Apesar disso, sua segurança ainda não foi estudada de maneira sistemática e alguns autores apresentam restrições ao seu uso por relatos de determinados eventos adversos. OBJETIVOS: descrever a ocorrência de eventos adversos sérios e comuns à pleurodese com PVP-I tópico. Avaliar se existe relação de dose-dependência na ocorrência dos eventos adversos; a efetividade clínica e a qualidade de vida dos pacientes. MÉTODOS: ensaio clínico envolvendo pacientes submetidos a pleurodese com PVP-I tópico, randomizados em dois grupos: grupo 1 com PVP-I tópico a 1% e grupo 2 com PVP-I tópico a 2%. A análise de segurança foi baseada na ocorrência de eventos adversos, graduados de acordo com o Common Terminology Criteria for Adverse Events. Foram realizadas avaliações clínicas e exames complementares no pré-operatório e em vários momentos do seguimento pós-operatório. Os dados clínicos avaliados foram dor, dispnéia, temperatura, pressão arterial, freqüência cardíaca, saturação de oxigênio e acuidade visual. Exames complementares envolveram hemograma, função renal, hepática e tireoidiana, eletrocardiograma e radiografia de tórax. A efetividade clínica foi determinada pela necessidade de procedimentos adicionais após a pleurodese e a qualidade de vida através de questionário específico. RESULTADOS: foram avaliados 60 pacientes, 30 em cada grupo. Predominou o sexo feminino, em 55 pacientes. A média de idade foi de 55,9 ± 11,7 anos. A etiologia mais comum do derrame pleural foi neoplasia de mama em 43 pacientes, seguida por neoplasia pulmonar e de ovário. Foram encontrados 47 eventos adversos sérios relacionados ao procedimento distribuídos em 34 pacientes nos primeiros 30 dias de avaliação. Foram eles: dor, em onze pacientes, hipertensão em dez, empiema em um, hiponatremia em oito pacientes, elevação da fosfatase alcalina, transaminase oxalacética e transaminase pirúvica em dez, três e um pacientes respectivamente e hipocalemia em um paciente. A taxa de sucesso foi de 96% e não houve mudança na qualidade de vida após o procedimento. Na comparação dos grupos não se observou diferença estatística em relação aos dados avaliados. CONCLUSÕES: Os eventos adversos sérios mais esperados após a realização de pleurodese com PVP-I tópico são dor, hipertensão e alguns distúrbios metabólicos. A pleurodese com PVP-I tópico mostrou ser um procedimento eficaz, mas não ofereceu melhora na qualidade de vida dos pacientes. Não se observou relação de dose-dependência na ocorrência dos eventos adversos e na eficácia do procedimento
BACKGROUND: Iodopovidone has been described as a sclerosing agent easily obtained, inexpensive and with good results. Despite this, its safety has not been systematically evaluated and some authors have restrictions to its use because of reports of some adverse events related. OBJECTIVE: To describe the occurrence of common and serious adverse events after iodopovidone pleurodesis. Second endpoints were to describe dose-dependent relation to adverse events, procedure efficacy and patient\'s quality of life. METHODS: clinical trial including patients with recurrent malignant pleural effusion, undergone to pleurodesis, randomized into two groups: group 1 received 1% iodopovidone and group 2 received 2% Iodopovidone. We sought adverse events systematically with clinical and complementary evaluations since before pleurodesis and on several times postoperative. Clinical evaluation involved pain analog scale, dyspnea scale, oxygen saturation, heart frequency, arterial blood pressure, body temperature and visual acuity. Complementary evaluation was done by electrocardiogram, chest x-ray and laboratory tests (hemogram, renal function, liver function and thyroid function). All adverse events were graduated according to the Common Terminology Criteria for Adverse Events (CTCAEV). Efficacy was considered when the patients did not need further pleural procedure after pleurodesis and quality of life analysis was determined by questionnaire. RESULTS: Sixty patients were enrolled, thirty in each group, 55 females and 5 males. Mean age was 55,9 ± 11,7. The mainly etiology of malignant pleural effusion was breast cancer, in 43 patients, followed by lung cancer and ovarian tumor. We found 47 serious adverse events, possibly related to iodopovidone pleurodesis that occurred in 34 patients on 30 days follow-up. Most frequent clinical adverse events of these were pain, eleven patients, hypertension, ten and empyema in one patients. Serious metabolic events founded were hyponatremia in eight patients, alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase increased in ten, three and one patients respectively and hypokalemia in one patient. Success rate occurred in 96%. We didn\'t find change on quality of life after pleurodesis. We found no difference in patient\'s demographical data, occurrence of adverse events, efficacy and quality of life between groups. CONCLUSIONS: Observed common and serious adverse events related to iodopovidone pleurodesis were pain, hypertension, and some metabolic alterations. We found good efficacy for iodopovidone pleurodesis, but no significant change in patient\'s quality of life after procedure. This report does not suggest dose-dependent relation for the occurrence of adverse events

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Carone, Gabriela Ferri. "Estudo observacional do uso da hipodermóclise em cuidados paliativos oncológicos." Universidade de São Paulo, 2016. http://www.teses.usp.br/teses/disponiveis/5/5160/tde-30062016-144200/.

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Hipodermóclise (HDC) é uma importante técnica alternativa para a administração de medicamentos e fluidos pela via subcutânea. É usada com frequência para o controle dos sintomas em pacientes em cuidados paliativos com dificuldade de acesso venoso e que são incapazes de tolerar medicação oral. No entanto, raros estudos abordaram o uso da HDC de uma forma global, para reposição hidroeletrolítica e terapia medicamentosa, tanto na forma contínua quanto intermitente, observando detalhes e complicações do seu uso. Os objetivos deste estudo incluíram caracterizar o uso da HDC para administração de medicamentos, soluções e eletrólitos e avaliar as possíveis complicações locais, identificando também outros fatores que influenciam sua ocorrência. Estudo observacional prospectivo com coleta de dados em prontuário e acompanhamento diário de pacientes internados com câncer avançado, da equipe de Cuidados Paliativos do Instituto do Câncer do Estado de São Paulo (ICESP) em uso de HDC, verificando local de punção, medicamentos administrados e possíveis complicações, acompanhando os detalhes de seu uso. A análise estatística não-paramétrica e método de regressão logística foram realizados. Foram acompanhados 99 pacientes com 243 punções, das quais 166 (68,3%) em coxa e 46 (18,9%) em abdome. Os medicamentos mais utilizados foram morfina em 122 (50,2%) punções, seguido de dipirona em 118 (48,6%) e dexametasona em 86 (35,4%). A solução mais prescrita foi a glicofisiológica em 38 (15,6%) punções, pelo seu aporte calórico. 13,6% das punções (33 de 243) tiveram complicações, sendo apenas seis casos maiores (edema). Complicações ocorreram mais frequentemente até o segundo dia da punção e foram associadas com o número (p=0,007) e o volume (p=0,042) de medicamentos administrados e também com a solução glicofisiológica (p=0,003) e os eletrólitos cloreto de potássio (p=0,037) e cloreto de sódio (p=0,013). Este estudo permitiu o conhecimento de fatores associados a complicações e propõe algumas recomendações, como: individualização da terapia, especialmente relacionada com o volume de escolha, número de medicamentos administrados e evitar a adição de eletrólitos na solução glicofisiológica
Hypodermoclysis (HDC) is an important alternative technique for the administration of drugs and fluids into the subcutaneous tissue. It is frequently used for symptom control in palliative care patients, with difficult venous access and unable to tolerate oral medications. However, few studies address the use of HDC as a whole to fluid replacement and drug therapy, both continuous and intermittent mode, observing details and complications of its use. The objectives of this study included characterizing the use of HDC to administer drugs, solutions and electrolytes and to evaluate possible local complications also identifying other factors influencing their occurrence. Prospective observational study with data collection in medical records and daily monitoring of advanced cancer inpatients of the palliative care team of São Paulo State Cancer Institute (ICESP) in use of HDC, checking infusion site, administered drugs and possible complications, following the details of its use. Non-parametrical statistical analysis and logistic regression were performed. Were followed 99 patients with 243 infusion sites, which 166 (68.3%) in the thigh and 46 (18.9%) in the abdomen. The most commonly used drugs were morphine in 122 (50.2%) infusion sites, followed by dipyrone in 118 (48.6%) and dexamethasone in 86 (35.4%). The most prescribed solution was dextrose 5%/0,9% saline in 38 (15.6%) infusion sites because of its caloric intake. 13.6% of punctures (33 of 243) had complications, only six larger cases (edema). Complications occurred mainly up to the second day of the infusion sites and were associated with the number (p=0,007) and volume (p=0,042) of drugs used as also with 5% dextrose/0.9% saline solution (p=0,003) and NaCl (p=0,037) and KCl (p=0,013) electrolytes. This study has allowed the knowledge of factors associated with complications and proposes some recommendations as: individualization of therapy especially related to the volume of choice, number of drugs administered, and avoid adding electrolytes to the 5% dextrose/0.9% saline solution

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Sales, Manuela Vasconcelos de Castro. "Efeitos cognitivos da quimioterapia adjuvante em pacientes com câncer de cólon." Universidade de São Paulo, 2018. http://www.teses.usp.br/teses/disponiveis/5/5155/tde-06042018-124633/.

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OBJETIVOS: Evidências consistentes sugerem que a quimioterapia (QT) sistêmica para o tratamento do câncer pode apresentar efeitos deletérios na cognição levando a prejuízos de memória, atenção, velocidade de processamento e função executiva. A maioria dos estudos anteriores, entretanto, foi realizada em mulheres com câncer de mama, o que levanta a possibilidade de que o déficit possa ter sido causado por alterações hormonais e/ou menopausa precoce induzidas pela QT. Pouco se sabe sobre a toxicidade da QT na cognição de pacientes portadores de câncer coloretal (CCR). O objetivo do estudo foi avaliar os efeitos cognitivos da QT adjuvante baseada em fluorouracil (5FU) associado ou não a oxaliplatina (FLOX) em pacientes portadores de CCR estádios II e III , em comparação a indivíduos com câncer de cólon estádio II de baixo risco não submetidos à QT. METODOLOGIA: Estudo de coorte prospectivo, não intervencionista, unicêntrico, onde os pacientes com CCR foram submetidos a uma avaliação neuropsicológica detalhada, além da avaliação de queixas subjetivas de memória e de sintomas depressivos antes do início da quimioterapia (t1) e após 12 meses de seguimento (t2). Avaliamos ainda o papel da apoliproteína E como preditor de risco para disfunção cognitiva e a presença de lesão de substância branca por ressonância magnética (RM) de crânio. RESULTADOS: Num período de 2 anos, de dezembro de 2012 a dezembro de 2014, 85 pacientes foram recrutados e completaram a avaliação inicial (t1): 26 no grupo controle (sem quimioterapia= QT-) e 59 no grupo casos (quimioterapia= QT+). Dentre os 85 pacientes que participaram da avaliação inicial, 16 foram excluídos da análise do desfecho principal. A maioria dos pacientes era do sexo masculino (60,3%), idosos com idade média de 62,5 anos (DP 9,4) e escolaridade média de 7,6 anos (DP 3,7). Considerando o desfecho primário do escore composto global e também os domínios cognitivos de memória e atenção, não econtramos diferença significativa de desempenho no t1 e t2 entre os grupos. Com relação a função executiva, os pacientes que realizaram QT apresentaram melhor desempenho no t1, entretanto, evoluíram com maior declínio e pior desempenho que os controles no t2 após ajuste para idade, sexo, escolaridade e sintomas depressivos no baseline (beta -1,80; 95%CI -3,50; -0,11, p=0,04). Um subgrupo de 32 pacientes foram submetidos a RM de crânio que não mostrou alterações significativas de substância branca pela técnica de imagem de tensor de difusão (DTI) no seguimento. A presença do alelo ?4 da apolipoproteína E não foi diferente entre os grupos. CONCLUSÃO: Pacientes portadores de câncer colorretal que receberam quimioterapia adjuvante com esquema FLOX apresentaram declínio no desempenho cognitivo no domínio função executiva em comparação a pacientes com doença localizada que não receberam QT após 12 meses de seguimento
PURPOSE: Cognitive dysfunction may occur after chemotherapy in cancer survivors, especially in those that received chemotherapy for breast cancer. The frequency and to which extent such toxicity develops in colorectal cancer (CRC) survivors is unknown. This prospective study evaluated the effects of adjuvant chemotherapy on the cognitive performance of patients with localized CRC in comparison with a control group who did not receive chemotherapy. METHODS: Consecutive patients with localized stages II and III CRC completed neuropsychological assessments, self-reported cognitive complaints questionnaires, and depressive symptoms evaluation before starting fluoropyrimidine-based adjuvant chemotherapy (t1) and after 12 months (t2). Control group was assessed at matching intervals. Blood was collected for apolipoprotein E (APOE) genotyping. Clinical and demographic data were also collected. Diffusion tensor imaging (DTI) data was acquired from a subset of participants at both time-points. RESULTS: From December 2012 to December 2014, 137 patients were approached and 85 patients were recruited: 59 received chemotherapy (CTh+) and 26 did not (CTh-), based on standard recommendation for adjuvant therapy for CRC. The mean age was 62.5 years (SD 9.4), 60% were male, and the mean years of education was 7.6 (SD 3.7). No difference was found on global composite score (p=0.38), attention (p= 0.84) or memory (p= 0.97) between the two groups during the followup (mean 375 days, SD 29). However there was a significant difference on executive function domain, after adjustment for age, sex, education, and depressive symptoms at baseline (beta - 1.80; 95%CI -3.50; -0.11, p=0.04), suggesting worse performance for the CTh+ group. In 32 patients who underwent MRI, there was no significant differences for all DTI indices in any white matter regions between CTh+ and CTh- groups during follow-up. APOE polymorphisms were not predictive of cognitive dysfunction. CONCLUSION: After adjusting for confounding factors, patients with CRC who received adjuvant fluorouracil with or without oxaliplatin presented cognitive decline on executive function after 12 months in comparison with patients with localized disease that did not receive chemotherapy

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Aroke, Edwin N. "A Pilot Study of the Pharmacogenetics of Ketamine-Induced Emergence Phenomena: A Dissertation." eScholarship@UMMS, 2016. https://escholarship.umassmed.edu/gsn_diss/43.

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Background: Up to 55% of patients administered ketamine, experience an emergence phenomena (EP) that closely mimics schizophrenia and increases their risk of injury. While genetics accounts for about 50% of severe adverse drug reactions, no studies have investigated genetic association of ketamine-induced EP in healthy patients. Ketamine is metabolized by CYP 2B6 enzymes and CYP 2B^8^ allele significantly alter ketamine metabolism. In addition, ketamine exerts most of its effects by inhibiting the N-methyl-D-aspartate receptor (NMADR), and NMDAR genes (GRIN2B) are associated with learning and memory impairment and schizophrenia. Purpose: To investigate the relationship between CYP2B6*6 and GRIN2B single nucleotide polymorphisms (SNPs) and ketamine-induced emergence phenomena (EP). Methods: This cross-sectional pharmacogenetic study recruited 75 patients having minor orthopedic, hand, foot, anorectal surgeries from two outpatient surgical centers. EP was measured with the Clinician Administered Dissociative State Scale (CADSS). DNA was genotyped using standard Taqman assays and protocols. Genetic association of CYP2B6*6 and GRIN2B (rs1019385 & rs1806191) SNPs and ketamine induced EP occurrence and severity were tested using multivariate logistic and linear regression, adjusting for age, ketamine dose, duration of anesthesia, and time since ketamine administration. Results: Forty-seven patients (63%) received ketamine and were genotyped. Nineteen EP cases were identified (CADSS > 4), leaving 28 non-EP controls. For our population, CADSS has an internal consistency reliability Cronbach’s alpha of 0.82, and could reliably distinguish ketamine from non-ketamine cases. Occurrence and severity of EP were not associated with CYP2B6*6 or GRIN2B (p > 0.1). Models removing genotype and containing age, ketamine dose, duration of v anesthesia, and time since ketamine administration significantly predicted EP occurrence (p = 0.001) and severity (p = 0.007). Presence and severity of EP did not affect patient satisfaction with care. Discussion: Younger age, higher dose and longer duration of anesthesia significantly predicted EP occurrence and severity among our sample. This study provides effect size estimates useful for the design of adequately powered future genetic association studies. The feasibility of recruitment from patients undergoing elective, outpatient surgeries and ease of post-operative EP assessment with CADSS supports our approach. However, the small sample size may have limited about ability to determine significant differences. Conclusion: Fully powered studies are needed to investigate this important phenomena. Determining factors for anesthesia-related EP symptoms may reduce risks and costs associated with this adverse medication effect.

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Resende, Laíse Soares Oliveira. "Fatores de risco associados às reações adversas a medicamentos antituberculose : uma revisão sistemática." Mestrado em Saúde Coletiva, 2013. http://repositorio.ufes.br/handle/10/1827.

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Introdução: Os problemas relacionados à interrupção e ao abandono do tratamento da tuberculose culminam em aumento da morbimortalidade. A ocorrência de reações adversas a medicamentos (RAM) é apontada como um dos principais fatores relacionados. Objetivo: Identificar evidência científica disponível sobre os fatores de risco associados às reações adversas decorrentes do uso de medicamentos antituberculose. Métodos: Trata-se de uma revisão sistemática em que se buscou estudos sobre fatores de risco associados às reações adversas aos medicamentos antituberculose nas bases Medical Literature Analysis and Retrieval System Online (MEDLINE), no período entre 1965 e 2013 e Literatura Científica e Técnica da América Latina e Caribe (LILACS), no período entre 1982 e 2013. Localizou-se 1389 artigos que passaram por uma triagem a partir da leitura dos títulos e resumos. A partir dessa análise, selecionou-se 85 estudos para serem lidos na íntegra. Ao final, 16 estudos foram incluídos na análise a partir dos critérios de elegibilidade adotados em cada etapa, que tiveram seus dados extraídos para os cálculos de Qui-quadrado, Mantel-haenszel, Odds ratio simples (OR) e combinada (ORc). Resultados: Os fatores de risco significantes para o desenvolvimento de RAM foram: idade (maior que 60 anos), esquemas de tratamento, alcoolismo, anemia, coinfecção pelo vírus da imunodeficiência humana ou vírus da hepatite, polimorfismo da N-acetiltransferase 2 (acetilador lento), além da deficiência de sódio, ferro e albumina. Enquanto as meta-análises evidenciaram que os fatores de proteção das RAM hepáticas são: sexo masculino (ORc=0,38; IC95%=0,20-0,72), idade >35 anos (ORc=0,38; IC95%=0,20-0,72), fenótipo acetilador rápido/intermediário da N-acetiltransferase 2 (ORc=0,41; IC95%=0,18-0,90). Conclusões: Há evidências para subsidiar o manejo de RAM antituberculose nos serviços de saúde pública.
Setting: The problems related to the interruption and the dropout of tuberculosis treatments lead to increased morbi-mortality. Drugs adverse effects are some of the main related reasons. Objective: To identify scientific evidence available about risk factors associated to adverse effects due to antituberculosis drugs usage. Design: A systematic review of studies about risk factors related to adverse effects of antituberculosis drugs selected in MEDLINE database from 1965 to 2013 and in LILACS database from 1982 to 2013. After screening papers by reading all titles and abstracts there were 1.389 approved papers. Based on this analysis, 85 papers were selected to be fully read. At the end, 16 papers were selected to be analyzed due to the eligibility criteria on each step, had their data extracted for calculation of Chi-square, Mantel-Haenszel, Odds ratio (OR) and combined Odds ratio (ORc). Results: Significant risk factors to the development of drugs adverse effects were: age over 60 years, treatment regimen, alcoholism, anemia, coinfection by human immunodeficiency or hepatitis viruses, phenotype slow acetylators of N-acetyltransferase 2 and the deficiency of sodium, iron and albumin. While, meta- analysis showed that protective factors of liver AED are: male (ORc = 0.38, 95%CI= 0.20 to 0.72), age > 35 years (ORc=0.38, CI95%=0.20 to 0.72), acetylator phenotype fast / intermediate of N-acetyltransferase 2 (ORc=0.41, 95% I= 0.18 to 0.90). Conclusion: There is evidence to support the management of antituberculosis AED in public health services.

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Braga, Fábio do Prado Florence. "Avaliação da acupuntura como método de tratamento preventivo e curativo de xerostomia decorrente da radioterapia." Universidade de São Paulo, 2006. http://www.teses.usp.br/teses/disponiveis/23/23139/tde-05052006-164329/.

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A xerostomia é um efeito adverso comum e frequentemente irreversível decorrente da radioterapia de neoplasias malignas da região de cabeça e pescoço, afetando, sobremaneira, a qualidade de vida dos pacientes. Diferentes métodos para solucionar tal problema são propostos, de resultados, todavia questionáveis. Este estudo avaliou a eficácia clínica da acupuntura como método de tratamento preventivo e curativo de tais condições. Os pacientes foram distribuídos, aleatoriamente, em três grupos: grupo preventivo, constituído de 12 indivíduos, sem queixa de secura bucal, tratados com 12 a 16 sessões de acupuntura, antes e durante a radioterapia; grupo curativo, constituído de 12 indivíduos, diagnosticados, clinicamente, com xerostomia severa, tratados com 12 aplicações de acupuntura após concluído o tratamento oncológico, e grupo controle, formado pelos mesmos indivíduos do grupo curativo no momento da primeira consulta, precedente à terapêutica com acupuntura. O tratamento foi conduzido de acordo com os princípios da medicina tradicional chinesa e medicina ocidental ortodoxa, realizado de forma padronizada para todos os pacientes, duas vezes por semana, por um período de 20 minutos cada sessão. A avaliação da eficácia terapêutica fundamentou-se na mensuração da xerostomia, conduzida sob duas formas: objetiva, através da sialometria, com o registro quantitativo dos índices de fluxo salivar em repouso e estimulado (IFSR e IFSE), e subjetiva, por intermédio dos questionários Xerostomia Inventory (XI) modificado, Escala Visual Analógica (EVA) e Treatment Emergent Symptom Scale (TESS), mensurando o grau de severidade dos sintomas. Os resultados obtidos no grupo preventivo foram estatisticamente significativos quanto as avaliações objetivas e subjetivas, evidenciados por índices de fluxo salivar mais elevados tanto para o IFSR (P<0.001) como para o IFSE (P<0.001) e pela menor intensidade dos sintomas (P<0.001), quando comparadas ao controle. Para o grupo curativo, resultados também significativos foram constatados em ambas as avaliações, demonstrados pelo aumento dos IFSR (P<0.05) e IFSE (P<0.05) e redução da sintomatologia (P<0.05), comparados aos valores iniciais. Constatamos também que houve efeito de grupo e os pacientes que se beneficiaram do método preventivo, obtiveram médias estatisticamente mais significativas (P<0.001), para ambas as respostas clínicas, objetivas e subjetivas. É lícito concluir que a acupuntura mostrou-se um importante método de tratamento de xerostomia decorrente da radioterapia, visto ter alcançado uma confiabilidade significativa de eficácia, que nos faz indicá-la e sugerir a disponibilização do método preventivo nos centros de tratamento.
Xerostomia is a common and usually irreversible radiotherapy side effect in patients with head and neck cancer, affecting the patients quality of life. Many attempts have been suggested to manage this condition nevertheless of questionable results. This study evaluated the acupuncture treatment efficacy as a preventive and curative method for radiation-induced xerostomia. The patients were randomly assigned in three groups: preventive, composed of 12 individuals, without complaints of dry mouth, treated with 12-16 acupuncture sessions, before and concomitant radiotherapy; curative, composed by 12 individuals, diagnosed with severe xerostomia, treated with 12 acupuncture sessions after radiation therapy, and control, comprised of the curatives group patients at the moment of the first visit, preceding this therapy. Acupuncture treatment, according to traditional Chinese medicine and occidental orthodox medicine concepts was performed twice a week, lasting 20 minutes each session, following standardize techniques for all patients. Acupuncture efficacy was evaluated, based upon objective and subjective methods of xerostomia measurements, performed by sialometry, measuring the resting and stimulated salivary flow rates (RSFR and SSFR), and by means of questionnaires such as Xerostomia Inventory (XI) modified, Visual Analog Scale (VAS) and Treatment Emergent Symptom Scale (TESS), which evaluated referred symptoms. Results obtained in preventive group, evidenced RSFR (P<0.001) and SSFR (P<0.001) significantly increased, and improvement of symptoms (P<0.001), compared with control. Within curative group, after acupuncture treatment, the results showed statistically significant improved for both resting and stimulated salivary flow rates (P<0.05) and reduces of referred symptoms (P<0.05). There were statistically differences between groups, being the patients in preventive group those who evidenced the most significant improved of values (P<0.001) for objective and subjective evaluations. We concluded that acupuncture plays an important role in xerostomias treatment, as shown by the results, reaching a significant confiability of efficacy, indicating and suggesting the preventive method at oncology centers.

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Bellón, Molina Víctor. "Prédiction personalisée des effets secondaires indésirables de médicaments." Thesis, Paris Sciences et Lettres (ComUE), 2017. http://www.theses.fr/2017PSLEM023/document.

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Les effets indésirables médicamenteux (EIM) ont des répercussions considérables tant sur la santé que sur l'économie. De 1,9% à 2,3% des patients hospitalisés en sont victimes, et leur coût a récemment été estimé aux alentours de 400 millions d'euros pour la seule Allemagne. De plus, les EIM sont fréquemment la cause du retrait d'un médicament du marché, conduisant à des pertes pour l'industrie pharmaceutique se chiffrant parfois en millions d'euros.De multiples études suggèrent que des facteurs génétiques jouent un rôle non négligeable dans la réponse des patients à leur traitement. Cette réponse comprend non seulement les effets thérapeutiques attendus, mais aussi les effets secondaires potentiels. C'est un phénomène complexe, et nous nous tournons vers l'apprentissage statistique pour proposer de nouveaux outils permettant de mieux le comprendre.Nous étudions différents problèmes liés à la prédiction de la réponse d'un patient à son traitement à partir de son profil génétique. Pour ce faire, nous nous plaçons dans le cadre de l'apprentissage statistique multitâche, qui consiste à combiner les données disponibles pour plusieurs problèmes liés afin de les résoudre simultanément.Nous proposons un nouveau modèle linéaire de prédiction multitâche qui s'appuie sur des descripteurs des tâches pour sélectionner les variables pertinentes et améliorer les prédictions obtenues par les algorithmes de l'état de l'art. Enfin, nous étudions comment améliorer la stabilité des variables sélectionnées, afin d'obtenir des modèles interprétables
Adverse drug reaction (ADR) is a serious concern that has important health and economical repercussions. Between 1.9%-2.3% of the hospitalized patients suffer from ADR, and the annual cost of ADR have been estimated to be of 400 million euros in Germany alone. Furthermore, ADRs can cause the withdrawal of a drug from the market, which can cause up to millions of dollars of losses to the pharmaceutical industry.Multiple studies suggest that genetic factors may play a role in the response of the patients to their treatment. This covers not only the response in terms of the intended main effect, but also % according toin terms of potential side effects. The complexity of predicting drug response suggests that machine learning could bring new tools and techniques for understanding ADR.In this doctoral thesis, we study different problems related to drug response prediction, based on the genetic characteristics of patients.We frame them through multitask machine learning frameworks, which combine all data available for related problems in order to solve them at the same time.We propose a novel model for multitask linear prediction that uses task descriptors to select relevant features and make predictions with better performance as state-of-the-art algorithms. Finally, we study strategies for increasing the stability of the selected features, in order to improve interpretability for biological applications

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Maia, Marina Valente. "Avaliação dos efeitos adversos às drogas (minocilina, ofloxacina e clofazimina) do esquema alternativo para tratamento da hanseníase multibacilar." Universidade Federal do Amazonas - Fundação Alfredo da Matta, 2012. http://tede.ufam.edu.br/handle/tede/3658.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
After introduction of multi-drug therapy (MDT/OMS) there were decline in prevalence coefficients and new cases detections, however, the records of drug resistance and relapse cases are threatening factors against lepra control, therefore, the importance of new alternative schemes and monitoring adverse effects, avoiding abandonment or irregularity to treatment. Objectives: Describe side-effects of multi-drug regimen containing minocycline, ofloxacin and clofazimine in multibacillary (MB) leprosy patients and analyse the clinicalbacteriologic indices. Materials and Methods: A prospective, descriptive and observational study, in multibacillary patients, including intolerance cases of standard MDT and relapse cases, carried out in Alfredo da Matta Foundation, Manaus, Amazonas, Brazil, during april 2010 and january 2012. The side-effects were recorded of every individual patient, filled during the course of alternative treatment. The patients received alternative therapy with daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin and 50mg of clofazimine and a month supervised dose of 300mg of clofazimine for 06 months, thereafter 18 months of daily self-administered doses of ofloxacin 400mg, clofazimine 50mg and month supervised dose of clofazimine 300mg. Results and Discussions: During research 26 patients were treated, however, of these, only 21 cases were included in this study. The mild and not persistent side-effects occurred in 33,3% of patients. From the 37 side-effects, 45,9% episodes was attributed to ofloxacin, such as abdominal pain, nausea, vomiting, headache and insomnia; 21,6% due to clofazimine, 100% of patients with skin pigmentation; however, no side-effets due to minocycline. Mean duration for the development of adverse effects from the start of therapy was 15,2 days. The media interval of follow-up was 13,7 months and 23,8% of patients completed the 24 months trerapy. All the patients tolerated the drugs well and the adhesion was satisfactory, among 15 patients that completed the first treatment year, 14 took 12 doses at 12 months from alternative regimen. Conclusion: The alternative therapy had a similar feasibility and operational mode from MB/MDT, with safe, well tolerated and good adhesion with no serious events. The side-effects attributed to alternative regimen were comparable to previous studies, however this new three drugs combination indicates the importance of these research results. No drug was stopped unlike others standard MDT studies which had treatment interruption by side-effects. There was significant correlation (p<0,001) between clinical classification and histopatologic diagnosis. At the end of first year, there was clinical improvement and bacteriologic index reduction. Nevertheless, it s necessary a follow-up and new inclusions to guarantee the efficacy and safe for the alternative regimen.
Após introdução do esquema poliquimioterápico padrão (PQT/OMS), houve declínio nos coeficientes de prevalência e detecção de casos novos, entretanto, os registros de resistência medicamentosa e casos de recidiva representam ameaça para o controle da hanseníase, por isso a importância da proposição de novos esquemas alternativos e a necessidade de monitorar seus efeitos adversos, evitando-se casos de abandono ou irregularidade ao tratamento. Objetivos: Descrever os efeitos adversos do esquema terapêutico alternativo, contendo a associação clofazimina, ofloxacina e minociclina, em pacientes com hanseníase multibacilar e análise da evolução clínico-baciloscópica dos pacientes. Materiais e Métodos: Estudo prospectivo, descritivo e observacional, de casos multibacilares, incluindo casos de recidiva da doença ou intolerância à poliquimioterapia padrão, realizado na Fundação Alfredo da Matta, Manaus, Amazonas, Brasil, no período de abril de 2010 e janeiro de 2012. Os efeitos adversos foram registrados em formulários individuais para cada paciente, preenchidos ao longo do tratamento. Os indivíduos receberam o esquema alternativo, composto de doses diárias auto-administradas de 100mg de minociclina, 400mg de ofloxacina e 50mg de clofazimina e dose mensal supervisionada de 300mg de clofazimina por seis meses, seguida de 18 meses de doses diárias autoadministradas de ofloxacina 400mg, clofazimina 50 mg e dose supervisionada mensal de clofazimina 300mg. Resultados: Durante o período foram selecionados 26 pacientes, dos quais 21 foram incluídos no estudo. Efeitos adversos leves e transitórios foram observados em 33,3% dos pacientes. Do total de 37 efeitos secundários, 45,9% foram atribuídos à ofloxacina, como dor abdominal, náuseas, vômitos, cefaléia e insônia; 21,6% associados à clofazimina, com relatos e observação em 100% dos pacientes de hiperpigmentação cutânea; entretanto, nenhum efeito foi relacionado à minociclina, especificamente. O tempo médio de desenvolvimento das reações adversas a partir do início do esquema foi de 15,2 dias. A duração média do acompanhamento dos pacientes foi de 13,7 meses, sendo que 23,8% dos pacientes já concluíram o tratamento em 24 meses. A adesão e regularidade ao esquema foram satisfatórias, dos 15 pacientes que já completaram o primeiro ano de tratamento, 14 indivíduos realizaram 12 doses do esquema proposto em 12 meses. Discussão/Conclusão: O esquema alternativo demonstrou viabilidade e operacionalização semelhantes ao esquema PQT/MB, com segurança, boa tolerabilidade e adesão dos pacientes. A porcentagem de efeitos adversos às drogas foi compatível a de outros trabalhos, contudo, a inovação na combinação das três drogas acima, demonstra a importância dos resultados desta pesquisa. Não houve registros de casos graves que indicassem à suspensão ou interrupção do tratamento. Houve correlação significativa (p<0,001) entre a classificação clínica e o diagnóstico histopatológico. Ao fim do primeiro ano do esquema alternativo, os pacientes apresentaram melhora clínica e redução do índice baciloscópico médio. Todavia, há necessidade de acompanhamento dos indivíduos e aumento do número amostral para garantir a eficácia e segurança ao tratamento em longo prazo.

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Garcia, Doladé Núria. "Anàlisi dels efectes adversos a medicaments en la població pediàtrica identificats per mitjà d’un programa de notificació espontània." Doctoral thesis, Universitat Autònoma de Barcelona, 2016. http://hdl.handle.net/10803/393918.

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En la població pediàtrica les reaccions adverses a medicaments són una causa important de morbimortalitat. El reconeixement per part dels prescriptors de la necessitat d’avaluar l’eficàcia i la seguretat dels medicaments que s’empren a pediatria contrasta amb l’escassa informació amb validesa científica en aquesta població. Les grans diferències farmacocinètiques i farmacodinàmiques dels nens respecte dels adults, juntament amb la manca d’assaigs clínics pediàtrics, fan necessari un seguiment específic prospectiu de les reaccions adverses als medicaments en els nens. L’objectiu d’aquesta tesi és contribuir al coneixement de les reaccions adverses a medicaments en la població pediàtrica per mitjà del Programa de Notificació Espontània del Sistema Espanyol de Farmacovigilància (SEFV). En aquesta tesi, s’han fet dues anàlisis: una anàlisi de les principals característiques de les pancreatitis induïdes per medicaments en població pediàtrica. Durant el període de l’estudi, es van rebre 58 casos de pancreatitis en nens, poc més d’un 6% de totes les pancreatitis d’aquesta base. Els medicaments més freqüentment implicats van ser l’L-asparaginasa en nens i l’àcid valproic en adolescents. Un 10% de les pancreatitis impliquen un antiretroviral, l’estavudina i la didanosina han estat els més freqüents. La majoria de les pancreatitis han estat greus. Dels 6 casos mortals 3 eren pacients amb una neoplàsia hematològica que rebien L-asparaginasa i 2 pacients eren VIH que rebien antiretrovirals. L’altra anàlisi va ser l’estudi de parasòmnies induïdes per montelukast, un medicament d’ús pediàtric en l’asma. Les més freqüents van ser els trastorns del son, més de la meitat eren malsons. Un 90% de les parasòmnies eren nens entre 2 i 11 anys. Les parasòmnies són reaccions potencialment greus, poden provocar conductes violentes i lesions durant el son. El Programa de Notificació Espontània del Sistema Espanyol de Farmacovigilància, «Programa de la Targeta Groga», és un mètode que permet la identificació ràpida de nous riscos. És especialment eficient en la detecció de senyals en reaccions poc freqüents, desconegudes o que triguen molt de temps a produir-se i que són difícils de detectar als assaigs clínics. Per això cal potenciar la farmacovigilància en nens. Cal recordar que alguns efectes indesitjats es poden prevenir, en aquest sentit és necessari un ús prudent dels medicaments.
Adverse drug reactions are a major cause of morbidity and mortality also in pediatric population. The need of prescribers to assess the efficay and safety of the drugs used in the pediatric population contrasts with the lack of valid scientific information for this population. That clearly differ from adults in pharmacokinetic and pharmacodynamic characteristics. Additionally, the lack of pediatric clinical trials increases the need of specific prospective surveillance system on adverse drug reactions. The aim of this thesis is to contribute to the knowledge of adverse drug reactions in the pediatric population through the spontaneous reports of suspected adverse drug reactions gathered by the Spanish Pharmacovigilance System (SPhS). Two aspects have been analyzed: an analysis of the main characteristics of drug-induced pancreatitis in pediatric population. During the study period, the SPhS received 58 reports of pancreatitis in children, just over 6% of all pancreatitis in this database. The drugs most frequently involved were: L-asparaginasa in children and valproic acid in adolescents. An antiretroviral has been involved in 10% of pancreatitis; stavudine and didanosine were the most frequent. Most reports described severe pancreatitis. Of the six fatal cases, three were patients with hematologic malignancy receiving L-asparaginasa and two were HIV patients receiving antiretroviral drugs. An additional analysis was the study of parasomnia induced by montelukast, a drug used in pediatric population to treat asthma. The most common parasomnia was sleep disorders (> 50 % nightmares). Up to 90 % of parasomnias were reported in children between 2 and 11 years. Parasomnias are potentially serious reactions, can cause injuries and violent behavior during sleep. The Spontaneous Reporting of Adverse Drug Reations Program –The «Yellow Card Scheme»– is a method that allows the quick identification of new risks associated to medicines. It is efficient for detecting new signals of rare and unknown reactions, as well as those with a long latency period that cannot be identified with randomized clinical trials. For this reason pharmacovigilance should be promoted in children. Is important to note that some adverse effects are preventable can be avoided. It is necessary for the prudent use of medicines.

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Moutinho, Inês Isabel Mano. "Estudo comparativo dos anestésicos sevoflurano vs isoflurano em coelhos (Oryctolagus cuniculi)." Bachelor's thesis, Universidade Técnica de Lisboa. Faculdade de Medicina Veterinária, 2010. http://hdl.handle.net/10400.5/2264.

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Dissertação de Mestrado Integrado em Medicina Veterinária
A introdução de espécies exóticas na prática clínica veterinária exige uma actualização constante nesta área. A anestesia é, muitas vezes, necessária para a elaboração de procedimentos de rotina nestes animais. Os anestésicos mais utilizados neste âmbito são os anestésicos voláteis, devido às suas características farmacológicas. São eliminados, principalmente pelos pulmões, evitando assim a formação de metabolitos tóxicos noutros órgãos. Possuem ainda um baixo coeficiente de solubilidade sangue/gás, permitindo uma rápida indução e recuperação anestésica. O Isoflurano é o anestésico volátil mais utilizado em veterinária, contudo, a recente introdução do Sevoflurano na prática clínica tem ganho popularidade nesta área. Ao contrário dos animais de companhia, os coelhos possuem características anatómicas e fisiológicas que dificultam a anestesia. Os principais problemas da anestesia nesses animais são o stress, a hipóxia e a presença de doenças subclínicas concomitantes, sendo assim essencial, uma correcta escolha do agente, assim como, da técnica anestésica a utilizar. O objectivo desta dissertação foi comparar os dois anestésicos em relação aos tempos de indução e recuperação anestésicos, a qualidade da indução e alguns efeitos cardio-respiratórios, assim como a temperatura, em cirurgias de rotina desta espécie. Foram anestesiados quarenta e dois animais, divididos aleatoriamente em dois grupos de vinte e um animais. Um grupo foi anestesiado com Sevoflurano e o outro com Isoflurano. A indução foi realizada com máscara anestésica. A anestesia com o Sevoflurano resultou num menor tempo de indução anestésico e numa melhor qualidade de indução comparado com o Isoflurano, contudo o tempo de recuperação anestésico foi semelhante para ambos os anestésicos. No grupo Sevoflurano verificou-se uma menor hipotensão e menor depressão dos mecanismos homeostáticos reguladores da temperatura, quando comparado com o grupo Isoflurano. Ambos os anestésicos estão associados a depressão cardiovascular e respiratória, de forma similar. Em geral, o Sevoflurano foi associado a menos efeitos adversos do que o Isoflurano, podendo assim, o seu uso, ser preferível ao Isoflurano, nesta espécie animal.
ABSTRACT - Comparative study of anesthetics Sevoflurane vs Isoflurane in rabbits (Oryctolagus cuniculi) - The anesthesia is essential in most of the routine procedures in exotic pets. Since there is a lack of information about anesthesia in rabbits, it was considered important to study their physiologic response to Sevoflurane and Isoflurane during several different surgical procedures. The volatile anesthetics are, currently, the most common used agents in exotic pet medicine, because of their pharmacologic characteristics. They are mostly eliminated in the lungs, preventing the formation of toxic metabolites in other organs, and in addition to this, they have low solubility in the blood, which allows a rapid induction and anesthetic recovery. Unlike cats and dogs, rabbits have anatomic and physiologic characteristics that difficult anesthesia, like stress, hypoxia and presence of subclinical diseases, so it’s important a correct choice of the agent as well as an appropriate anesthesia technique. Isoflurane is still the most used, however Sevoflurane, which was recently introduced in exotic pet medicine, its gaining popularity among clinicians. The purpose of this thesis was to compare times of anesthetic induction and recovery, cardiopulmonary, temperature and behavioral effects of Sevoflurane and Isoflurane anesthesia in routine surgeries of rabbits. Forty-two rabbits were randomly divided in two equal groups, both of them were induced with anesthetics masks, however in one group it was used Sevoflurane for induction and maintenance, and in the other one was used Isoflurane. The cardiopulmonary parameters and temperature were recorded every five minutes. Sevoflurane showed shorter induction time and better quality of induction than Isoflurane, however the recovery time was similar in both anesthetics. It also noticed less hypotension effects and less depression of homeostatic mechanisms that control body temperature when compared with Isoflurane. Both anesthetics were related with cardiovascular and respiratory depression in a similar manner, nevertheless, Sevoflurane was associated with less adverse effects. In conclusion, the use of Sevoflurane may be preferable to the use of Isoflurane in rabbit anesthesia.

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Nunes, Mérces da Silva. "O direito fundamental à alimentação: Efeitos adversos dos alimentos industrializados e a saúde humana." Pontifícia Universidade Católica de São Paulo, 2006. https://tede2.pucsp.br/handle/handle/7461.

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The present paper aims at investigating the occurrence of side effects by industrialized food in human health with the point of examining whether this food available to the consumers is in agreement to the health safety patterns, which are essential to the satisfaction of basic needs of a healthy body, as well as the constitutional warranties that provide to brazilians the fundamental right to nourishment, healthy quality of life and to the safety of human health. As a social right, the right to health is assured by the brazilian constitution of 1988. For its effectiveness, it depends on positive statements from the government. The nourishment, one of the determining factors to health and crucial to the life keeping, is the condition to the achievement of all the other rights, being, therefore, a fundamental right of the human being. With the evidences that the regular consumption of industrialized food, especially when and if alligned with other factors equally harmful to human health, is directly or indirectly associated with the surging of non-transmissable chronic diseases (DCNT), such as diabetes, heart diseases, Parkinson and Alzheimer diseases, osteoporosis, high blood pressure, liver diseases, strokes, trombosis among other illnesess and patologies, the present paper has considered the analisys of the responsability of the government and companies concerning the duty of refunding the consumer because of potencial and/or effective risks generated by the availibility of unsafe food in the market. That is to say, products produced with the use of substances proving harmful to human health, as well as lack and bad conditions of sanitary vigilance concerning the inexistance of mechanisms or effective programmes for controlling and checking of quality patterns, identity and safety of nourishment that should be applied continuously and permanently to the achievement of the protection assured by the constitution. Due to the conclusions of this research and based on the constitutional principle of human being dignity, in the fundamental right to nourishment, to a healthy quality of life, to health and to the right to information, it was presented a suggestion of introducing the theme WARNINGS in the information of the compulsory lable. This topic should provide information concerning the side effects that the substancs used in the manufacturing of these products can bring about to human health
O presente trabalho tem por objetivo investigar a ocorrência de efeitos adversos dos alimentos industrializados na saúde humana com a finalidade de examinar se esses alimentos introduzidos e disponibilizados ao consumidor atendem os padrões de segurança alimentar indispensáveis à satisfação das necessidades básicas de um organismo saudável, bem como as garantias constitucionais que asseguram aos brasileiros o direito fundamental à alimentação, à sadia qualidade de vida e à incolumidade da saúde humana. Como um direito social, o direito à saúde é assegurado pela Constituição de 88, dependendo para sua efetivação, de prestações positivas do Estado. A alimentação, um dos fatores determinantes da saúde e indispensável à manutenção da vida, é condição de realização de todos os outros direitos, sendo, por isso, um direito fundamental da pessoa humana. Frente às evidências de que o consumo regular de alimentos industrializados, sobretudo quando e se aliado a outros fatores igualmente prejudiciais à saúde humana, está associado de modo direto ou indireto aos casos de aparecimento de doenças crônicas não transmissíveis (DCNT) entre as quais destacam-se: diabetes, doenças cardiovasculares, mal de Parkinson, Alzheimer, osteoporose, hipertensão arterial, cirrose hepática, acidente vascular cerebral, trombose, entre diversas outras enfermidades e patologias, o presente trabalho contemplou a análise da responsabilidade do Estado e das empresas quanto ao dever de indenizar o consumidor pelos riscos potenciais e/ou efetivos gerados tanto pela disponibilização no mercado consumidor de alimentos não seguros, isto é, de produtos alimentícios fabricados com o emprego de substâncias comprovadamente nocivas à saúde humana, como pela insuficiência e precariedade das ações de vigilância sanitária face à inexistência de mecanismos e/ou programas efetivos de controle e aferição dos padrões de qualidade, identidade e inocuidade dos alimentos que deveriam ser implementados de forma contínua e em caráter permanente para realização da proteção assegurada constitucionalmente. Diante das conclusões e com amparo no princípio constitucional da dignidade da pessoa humana, do direito fundamental à alimentação, do direito à sadia qualidade de vida, à saúde e ao direito de informação, foi apresentada sugestão de colocação de Advertências nas informações de rotulagem obrigatória relativas aos efeitos adversos que os componentes utilizados na fabricação daquele produto possam causar à saúde humana

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Lima, Talita Oliveira de. "Eficácia da laserterapia transcutânea sobre efeitos adversos da quimioterapia ensaio clínico randomizado /." Botucatu, 2019. http://hdl.handle.net/11449/190978.

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Orientador: Silvia Cristina Mangini Bocchi
Resumo: Introdução. Verifica-se eficácia no uso da laserterapia transcutânea (Intravenous Laser Irradiation of Blood – ILIB) na saúde dos indivíduos, entretanto, existem escassas evidências científicas para tratamento dos efeitos colaterais de quimioterápicos citotóxicos. Objetivo. Avaliar a eficácia dos protocolos ILIB 30’ e 60’ com comprimento de onda de 660nm sobre os efeitos colaterais no trato gastrointestinal (náuseas, vômitos, diarreias e constipação) e no tecido hematopoiético (plaquetopenias, neutropenias e alterações da hemoglobina), em pacientes oncológicos recebendo tratamento quimioterápico endovenoso. Método. Ensaio clínico, randomizado, unicego e aprovado por Comitê de Ética em Pesquisa (CAE 82323318.90000.5411, Parecer 2.512.164) e pelo Registro Brasileiro de Ensaios Clínicos (RBR – 7y8rtz). Estudo realizado em serviço ambulatorial de quimioterapia de hospital público do estado de São Paulo, Brasil. A amostra constituiu de 55 pacientes ³ 18 anos, com tumores sólidos, a partir do segundo ciclo de tratamento quimioterápico com fármacos endovenosos citotóxicos para o trato gastrointestinal e tecido hematopoiético, assim alocados nos grupos de seguimentos: 21 no controle, 21 no ILIB 30’ e 13 no ILIB 60’. A aplicação deu-se por via transcutânea sobre a artéria radial, utilizando-se aparelho de laser de baixa intensidade com comprimento de onda de 660nm. Considerou-se eficácia a manutenção ou aumento dos parâmetros mínimos hematológicos (hemoglobina, plaquetas e neutrófilos... (Resumo completo, clicar acesso eletrônico abaixo)
Mestre

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Pagano, Cassia Garcia Moraes. "Efeito do formato de informações escritas sobre reações adversas na compreensão dos usuários de medicamentos." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2016. http://hdl.handle.net/10183/158314.

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Comunicar aos pacientes os riscos de reações adversas dos medicamentos é fundamental para a tomada de decisão adequada dos pacientes, pois a informação aprimora seu conhecimento e influencia suas atitudes, auxiliando os pacientes a melhorar sua saúde. Estudos têm demonstrado que existem grandes diferenças individuais na interpretação de termos que são comumente usados para expressar risco de experimentar uma reação adversa e que a compreensão é influenciada pela apresentação da informação, bem como por fatores relacionados ao indivíduo, como o letramento em saúde e a habilidade numérica. O objetivo geral deste estudo foi avaliar o efeito de diferentes formatos de informações escritas na compreensão de reações adversas de medicamentos pelo usuário. Primeiramente foi realizada uma revisão sistemática a fim de avaliar as evidências do efeito de diferentes formas de informar sobre reações adversas na compreensão dessas informações pelo usuário de medicamentos. Em uma segunda etapa, foi realizado ensaio clínico randomizado duplo- cego (n=393), para avaliar a eficácia de três formatos, baseados nos resultados preliminares da revisão sistemática. Para a realização da revisão sistemática foram utilizadas as bases PubMed, Cochrane, EMBASE, SCIELO, LILACS, CINAHL, IPA, Web of Science, SCOPUS, OneFile, EBSCO e Clinical Trials, Proquest e Open Grey. O período de cobertura foi do início da base de dados até setembro de 2015. Foram incluídos na revisão estudos que comparassem a compreensão de dois ou mais formatos de informações escritas sobre a frequência de reações adversas, fornecidos a dois ou mais grupos de pacientes, com qualquer delineamento. Ao total, 23 ensaios clínicos realizados nos Estados Unidos e Reino Unido foram incluídos, envolvendo 14.342 participantes. Entre os estudos incluídos, 14 compararam formatos numéricos e nominais em diferentes combinações, 5 compararam formatos gráficos e os demais apresentaram outros formatos, como risco complementar versus risco total, diferentes formatos no denominador (100 x 1000), risco absoluto, risco relativo e NNH (número necessário para causar dano). A grande heterogeneidade entre os estudos não tornou possível a metanálise dos dados. Formatos numéricos demonstraram superioridade aos não-numéricos (nominal) na compreensão das informações. O uso de formatos gráficos comparados a textos também melhoraram a compreensão. A partir dos estudos avaliados nessa revisão, ainda não é possível definir qual o melhor formato para comunicar sobre reações adversas a medicamentos. Por exemplo, não há estudos comparando os formatos verbal, numérico, combinado e gráfico, o que favoreceria uma avaliação sobre o formato mais adequado à compreensão dos usuários de medicamentos. Na segunda etapa, foi realizado um ensaio clínico randomizado duplo-cego, em paralelo, unicêntrico. Usuários adultos de uma farmácia escola, com capacidade leitora avaliada pelo instrumento de Avaliação Breve de Alfabetismo em Saúde em Português para adultos (SAHLPA), foram randomizados para um dos três grupos: nominal + faixa de porcentagem, faixa de porcentagem e porcentagem absoluta. O desfecho principal foi a compreensão, avaliada como essencial (impressão geral da informação), literal (numérica especificamente), e classificada em adequada e inadequada. A percepção dos usuários quanto à satisfação da informação, intenção de tomar o medicamento, facilidade de entendimento e clareza das informações recebidas foram avaliadas como desfechos secundários. Foi utilizado teste de análise da variância (ANOVA) e qui-quadrado de Person para a comparação das diferenças. Os participantes foram recrutados no período entre junho a outubro de 2015 e foram entrevistados durante 35 minutos, em média; no total 393 participantes foram randomizadas para um dos três grupos. A compreensão essencial adequada foi de 65,6% para o formato nominal + faixa de porcentagem (n=128), 63,4% para faixa de porcentagem (n=131), 62,3% para porcentagem absoluta (n=131), sem diferença estatisticamente significativa entre os formatos (p >0,05). A compreensão literal adequada foi de 53,9% para o formato nominal + faixa de porcentagem, 44,3% para faixa de porcentagem e 48,5% para porcentagem absoluta, também sem diferença estatisticamente significativa entre os formatos (p >0,05). Os participantes que receberam o formato de porcentagem absoluta consideraram a informação mais clara (p<0,05), em comparação ao outros grupos. Não houve diferença estatisticamente significativa entre os três formatos quanto aos desfechos secundários. Os resultados não demonstram diferenças na compreensão das informações entre os três formatos avaliados, portanto, os três formatos avaliados são equivalentes para informar a frequência das reações adversas. No entanto, a baixa compreensão apontada pelos resultados, demonstra que formatos alternativos precisam ser avaliados. Levando em consideração que os formatos numéricos demonstram-se mais eficazes em relação aos não-numéricos, e que os formatos gráficos podem auxiliar na compreensão de informações sobre reações adversas, um formato alternativo para informar as reações adversas relacionadas aos medicamentos precisa ser desenvolvido, a partir das necessidades dos usuários. É preciso considerar as preferências, nível de letramento em saúde e habilidades numéricas dos usuários de medicamentos. A disponibilização das bulas não deve ser apenas para cumprir as prerrogativas legais, mas sim deve cumprir seu papel de informar os usuários, de maneira eficiente, com conteúdo e formato adequados e compreensíveis. Por isso, é imprenscindível que as informações e seus formatos sejam avaliados pelos usuários de medicamentos, antes de serem empregados em materiais informativos, como a bula de medicamentos.
Communicate to patients the risks of side effects of drugs is critical for making appropriate decision by patients because the information enhances their knowledge and influence their attitudes, helping patients improve their health. Studies have shown that there are large individual differences in the interpretation of terms that are commonly used to express risk of experiencing a side effects and that understanding is influenced by the presentation of information, as well as factors related to the individual, such as literacy in health and numeracy. This study aim was to evaluate the effect of different formats of written information in the understanding of side effects by medicines user. First, was conducted a systematic review to assess the evidence of the effect of different ways to report side effects understanding of this information by the medicines user. In a second moment, clinical trial was conducted double-blind randomized (n = 393) to evaluate the efficacy of three formats, based on preliminary results of a systematic review. For the systematic review were used the MEDLINE (PubMed), Cochrane, EMBASE, SCIELO, LILACS, CINAHL, IPA, Web of Science, Scopus, OneFile, EBSCO and Clinical Trials, and Proquest Open Grey. The coverage period was the beginning of the database until September 2015. Were included in the review studies comparing the understanding of two or more written information formats on the frequency of adverse reactions, provided two or more groups of patients, any design. A total of 23 clinical trials in the United States and the United Kingdom were included, involving 14,342 participants. Among the included studies, 14 compared numerical and verbal formats in different combinations, 5 compared graphic formats and others showed other formats such as additional risk versus overall risk, different formats in the denominator (100 x 1000), absolute risk, relative risk and NNH (number needed to harm), positive versus negative frames. The heterogeneity between the studies did not make possible the meta-analysis of the data. Numerical forms demonstrated superiority to non-numeric in understanding the information. The use of graphics formats compared to texts also improved understanding. From the studies evaluated in this review, it is not possible to determine the best format for reporting on side effects. For example, there are no studies comparing the verbal descriptors, numeric, graphic and combined, which would favor an evaluation of the most appropriate format for the understanding of medicines users. In the second stage, was conducted a clinical trial randomized double-blind, parallel, single-center. Adult users of a pharmacy school, with reading capacity assessed by the Brief Assessment Instrument Literacy Health in Portuguese for adults (SAHLPA), were randomized to one of three groups: verbal + range of percentage, percentage range and absolute percentage. Main outcome variables were verbatim (specific numerical) and gist knowledge, classified as adequate and inadequate. The perception of users and the satisfaction of information, intended to take the drug, ease of understanding and clarity of information received were assessed as secondary endpoints. Was used analysis of variance test (ANOVA) and chi-square Person to compare the differences. Participants were recruited between June and October 2015 and were interviewed for 35 minutes on average; in total 393 participants were randomized to one of three groups. The adequate levels of gist knowledge was 65.6% and 53.9% for nominal format + percentage range (n = 128), 63.4% and 44.3% for percentage range (n = 131), 62 3% and 48.5% for absolute percentage (n = 131), with no statistically significant difference between the groups (p> 0.05). The adequate levels of verbatim knowledge was 53.9% for the nominal format + percentage range, 44.3% for percentage range and 48.5% for absolute percentage, also with no statistically significant difference between the groups (p> 0.05 ). Participants who received absolute percentage format considered the clearest information (p <0.05) compared to the other groups. There was no statistically significant difference between the three formats as the secondary outcomes. The results do not show differences in the understanding of information among the three formats, so the three evaluated formats are equivalent to inform the frequency of adverse reactions. However, poor understanding of the results indicated shows that alternative formats must to be evaluated. Taking into account that numerical formats are more effective than numerical ones, and that graphical formats can assist in understanding information on adverse reactions, an alternative format for reporting adverse drug-related reactions needs to be developed from needs of medicine users. It is necessary to consider the preferences, level of literacy in health and numerical abilities of the users of medicines.

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Matias, Caio César Marconato Simões. "Efeitos adversos produzidos pela estimulação cerebral profunda aguda do núcleo subtalâmico e suas correlações com características neuroanatômicas, localização do eletrodo e parâmetros de estimulação." Universidade de São Paulo, 2016. http://www.teses.usp.br/teses/disponiveis/17/17137/tde-04012017-170612/.

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A estimulação cerebral profunda do núcleo subtalâmico (NST) é um tratamento bem estabelecido para os sintomas refratários à medicação em paciente com doença de Parkinson avançada. Além do procedimento de implante, a programação dos eletrodos é uma etapa fundamental para atingir os resultados desejados. A primeira etapa da programação é estabelecer os limiares para efeitos adversos. Contudo, a correlação entre a localização do eletrodo e o limiar para efeitos adversos associados à estimulacao das estruturas adjacentes ainda não é bem estabelecida. Características neuroanatômicas e a localização dos eletrodos foram identificadas utilizando-se um programa de planejamento de cirurgia estereotáxica, enquanto os parâmetros de estimulação e os efeitos adversos foram obtidos dos prontuários médicos. As correlações entre estas variáveis foram testadas através de análises univariadas e análises multivariadas. Estimulação monopolar produziu efeitos adversos capsulares (EA-C) em 208 dos 316 contatos (65,8%) e efeitos adversos não-capsulares (EA-NC) em 223 dos 316 contatos (70,6%). A ocorrência de EA-C esteve associada com o número do contato (p = 0,009) e com a coordenada \"Z\" (p = 0,03), enquanto o limiar de voltagem para EA-C esteve correlacionado com o ângulo da cápsula interna (p = 0,035). A ocorrência de EA-NC esteve associada com o número do contato (p = 0,005), \"X\" (p = 0,03), \"Y\" (p = 0,004) e com a distância para o núcleo rubro (p = 0,001 e p = 0,003). Houve correlação entre o limiar de voltagem para EA-NC e o ângulo da cápsula interna (p = 0,006), o ângulo coronal do eletrodo (p = 0,02), \"X\" (p = 0,001), \"Y\" (p < 0,001), \"Z\" (p < 0,001) e com as distâncias para a cápsula interna (p = 0,02) e para o núcleo rubro (p = 0,004 e p < 0,001). EA-C estiveram associados com os contatos mais distais do eletrodo e com localização mais profunda, bem como com maior angulação da cápsula interna. EA-NC estiveram associados com os contatos mais distais do eletrodo, localizados mais medial, posterior e inferiormente e mais próximos do núcleo rubro. Ademais, houve associação entre EA-NC e eletrodos implantados com maior ângulo coronal, bem como com maior angulação da cápsula interna. Estes achados poderão ser úteis no desenvolvimento de novas estratégias para o planejamento do implante de eletrodos de estimulação cerebral profunda.
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-established treatment for medically refractory motor symptoms of patients with advanced Parkinson\'s disease. Programming of the device is as relevant to patient outcome as accurate implantation of the electrodes. The first step of DBS programming is to identify the thresholds to side effects. However, the relationship between lead location and the threshold to adverse effects is not fully understood. Anatomical measurements and electrode location were evaluated on a stereotactic surgical planning software, whereas stimulation parameters and side effects were obtained from medical records. Correlations among these variables were tested using univariate and multivariable analyses. Monopolar stimulation elicited capsular side effects (CSEs) in 208 of 316 contacts (65.8%) and noncapsular side effects (NCSEs) in 223 of 316 contacts (70.6%). The occurrence of CSEs was correlated with contact number (p = 0,009) and with the \"Z\" coordinate (p = 0,03), whereas voltage threshold to CSEs exhibited correlation with the internal capsule angle (p = 0,035). The occurrence of NCSEs was correlated with contact number (p = 0,005), \"X\" (p = 0,03), \"Y\" (p = 0,004), and the distance to the red nucleus (p = 0,001 and p = 0,003). There was correlation between voltage threshold to NCSEs and the internal capsule angle (p = 0,006), electrode\'s coronal angle (p = 0,02), \"X\" (p = 0,001), \"Y\" (p < 0,001), \"Z\" (p < 0,001), and the distances to the internal capsule (p = 0,02) and to the red nucleus (p = 0,004 and p < 0,001). CSEs were associated with more distally contacts, with deeper localization, as well as with greater internal capsule angles. NCSEs were associated with more distally contacts, with localization more medial, posterior and inferior, and closer to the red nucleus. Moreover, there was a correlation between NCSEs and electrodes implanted with greater coronal angles, as well as with greater internal capsule angles. These findings can be useful to inform novel targeting strategies for deep brain stimulation lead implantation.

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Scharfenort, Monica. "Behandlingskomplikationer vid pumpbehandlingar med levodopa/karbidopa gel hos patienter med Parkinsons sjukdom. En systematisk litteraturstudie." Thesis, Malmö högskola, Fakulteten för hälsa och samhälle (HS), 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:mau:diva-24784.

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Kontinuerlig infusion med levodopa/karbidopa gel hos patienter med avancerad Parkinsons sjukdom har visat sig vara en effektiv behandling men innebär även komplikationer. Studiens syfte är att kartlägga vilka behandlingskomplikationer som redovisas i litteraturen. Metoden är en systematisk litteraturstudie där databaserna PubMed, Cochrane, Cinahl och Embase har genomsökts. Resultatet grundar sig på 12 observationsartiklar och en randomiserad kontrollerad studie som visar att behandlingskomplikationer är vanliga, de är varierande i allvarlighetsgrad och kan indelas i fyra grupper beroende på om de är relaterade till kirurgi, det tekniska systemet, den medicinska behandlingen eller inte relaterat alls till behandlingen utifrån dagens kunskap. Slutsats: Det vetenskapliga underlaget är otillräckligt för att sammanställa hur de redovisade behandlingskomplikationerna hör ihop med behandlingen. Därför rekommenderas ytterligare forskning där samband kopplat till baslinjevariabler och socioekonomiska variabler samt samband mellan de olika behandlingskomplikationerna att undersökas ytterligare.
Continuous levodopa/carbidopa intestinal gel is reported to be efficient in the treatment of advanced Parkinson Disease but also associated with adverse events. The aim of this study was to provide an overview of the reported adverse events through a systematic review. The databases PubMed, Cochrane, Cinahl and Embase were searched. The results are based on 12 observational studies and one randomized control trial and shows that adverse events are common and the degree varies. Four categories to which the adverse events can be related were identified; due to the surgery, the device, the medication or not related to the treatment at all. Conclusions: The evidence is considered inadequate to base a statement of how the adverse events are correlated to the treatment why further studies with evaluation of baseline and socioeconomic variables as well as among the different adverse events are recommended.

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Terning, Fredrik, Anna Ahl, and Sofie Söderström. "Datorbaserad rapportering av biverkningar och symptom vid cytostatikabehandlad avancerad bröstcancer." Thesis, Uppsala University, Department of Public Health and Caring Sciences, 2009. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-112554.

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Syftet är att beskriva symtom och biverkningar som kvinnor med avancerad bröstcancer och cytostatikabehandling rapporterat i ett datoriserat rapporteringssystem före läkarbesök. Undersöka tillfredsställelsen med detta system; se om det finns en skillnad mellan äldre och yngre; undersöka kvinnornas uppfattning om vad som kan förbättras i uppföljningen av symtom/biverkningar samt stödet från läkare. Detta är en kvantitativ, deskriptiv tvärsnittsstudie baserat på rapporteringssystemets databas samt enkätundersökning.

Biverkningarna trötthet, smärta och nervpåverkan rapporterades mest frekvent. Tidsåtgången för rapportering ansågs utav de flesta vara kort eller mycket kort och formuläret upplevdes av majoriteten vara ganska lätt till mycket lätt att använda oberoende av datorvana. Läkaren ansågs från hög grad till mycket hög grad vara ett stöd i att hantera symtom och biverkningar av två tredjedelar av respondenterna. Hälften ansåg att rapporterade biverkningar och symtom uppmärksammades av läkaren i hög grad till mycket hög grad.

Undersökningen bekräftar det tidigare forskning visat om datoriserade rapporteringssystem i vården, att de är funktionella oavsett ålder samt att intresse finns för att använda dessa i större utsträckning. På grund av litet urval och relativt stort bortfall i enkätstudien kan dock inga direkta slutsatser dras men undersökningen antyder att behov finns att vidareutveckla rapporteringssystemet.

The aim of the study is to describe symptoms and side effects that women with advanced breast cancer and chemotherapy reported in an adverse drug reporting system before seeing their oncologist; examine the satisfaction with this system; if there are any differences between older and younger women; the women’s opinion of what improvements could be done in the follow-up of the symptoms/side effects and the support from the oncologist. This is a quantitative, descriptive cross-sectional study based on the database of the adverse drug reporting system and the questionnaire survey.

The side effects fatigue, pain and peripheral neuropathy were most frequently reported. The time consumption for reporting was considered short or very short and the majority thought that the questionnaire was fairly easy to very easy to use independent of computer habits. The oncologists where considered from a high extent to a very high extent being a support in handling the symptoms/side effects by two thirds of the respondents. Two fourths felt that the oncologists attended reported symptoms/side effects from a high extent to a very high extent.

Because of a small sample and a relatively large drop-out no real conclusions can be drawn except the need for further development of the system.

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Ponchet, Maria Raquel Nogueira Cavalcante. "Avaliação dos efeitos adversos, com ênfase na retinotoxicidade, desencadeados pelo uso de difosfato de cloroquina em 350 doentes com lupus eritematoso." Universidade de São Paulo, 2005. http://www.teses.usp.br/teses/disponiveis/5/5133/tde-10102014-112955/.

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Os antimaláricos, cloroquina e hidroxicloroquina, têm sido usados há décadas com bons resultados terapêuticos para o tratamento do lupus eritematoso e são considerados medicações seguras, muito embora, haja preocupação em relação à retinotoxicidade, notadamente com a cloroquina. O objetivo deste trabalho foi avaliar a ocorrência dos efeitos adversos desencadeados pelo tratamento com 250mg/d de difosfato de cloroquina em doentes com lupus eritematoso, dando ênfase à retinotoxicidade. Foram estudados 350 doentes e reavaliados seus respectivos prontuários, que datavam de 1980 a 2003. Os doentes foram acompanhados no ambulatório de colagenoses da Divisão de Dermatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. A ocorrência dos efeitos adversos foi de 35,7%, sendo que 17,4% decorreram de alterações oculares. Em 12% dos doentes ocorreu pigmentação retiniana sugestiva de retinopatia antimalárica, em 3,1% depósitos corneanos e, em 2,3%, sintomas visuais agudos. Em 10% dos doentes houve alterações gastrointestinais: epigastralgia (6%), náuseas e vômitos (3,7%) e diarréia (0,3%). Alterações dermatológicas ocorreram em 3,4% dos doentes: rash cutâneo no início do tratamento (2%), exacerbação de quadro de psoríase pré-existente (0,3%) e pigmentação cutânea (1,1%). Ocorreram ainda cefaléia (2,9%), alterações neuromusculares (1,7%) com quadro gripal símile no início do tratamento (1,1%), neuropatia sensitiva (0,3%) e miopatia compatível com miastenia (0,3%) e, sintomas neuropsiquiátricos (0,3%). A droga foi suspensa devido aos efeitos adversos em 22,9% dos doentes, principalmente, em decorrência de alterações oculares, gastrointestinais e dermatológicas. A reavaliação oftalmológica de 12% dos doentes com pigmentação retiniana, confirmou a retinopatia antimalárica em apenas 2,6%, o que demonstrou uma tendência à valorização de alterações retinianas inespecíficas, discretas e unilaterais, com indicação desnecessária da suspensão da droga em 9,4% dos doentes. Não ocorreram casos de retinopatia antimalárica avançada com lesão do tipo bull-eye. Não houve associação estatisticamente significativa entre a ocorrência de efeitos adversos e alterações retinianas com dose diária de difosfato de cloroquina por quilo de peso e com o tipo clínico do lupus eritematoso. As alterações retinianas foram estatisticamente significativas nos doentes acima de cinqüenta anos quando comparado ao grupo abaixo dos cinqüenta anos, possivelmente pela dificuldade em diferenciar as alterações iniciais da retinopatia antimlárica daquelas decorrentes da degeneração macular senil. O controle oftalmológico foi realizado em intervalo médio de 10,5 meses, demonstrando que o controle anual foi eficaz para o acompanhamento dos doentes. Nove doentes foram expostas durante o primeiro trimestre gestacional, não ocorrendo casos de mal formação fetal
Antimalarial agents, chloroquine and hydroxichloroquine, have been used for decades leading to good therapeutic outcomes at treatment approach for lupus erythematosus and are considered safe medication; however, the main concern is retina toxicity, especially with chloroquine. The purpose of the present study was to conduct analysis of the occurrence of adverse effects, triggered by use of 250 mg/d of chloroquine diphosphate at treatment for lupus erythematosus, especially retina toxicity. We analyzed 350 patients and reviewed their medical charts, from 1980 to 2003. The patients were followed up by the outpatient unit of collagenosis, Division of Dermatology, Hospital das Clinicas, Medical School, University of São Paulo. The occurrence of adverse effects was 35.7%, and eye affections were detected in 17.4% of patients. Impairment of retina pigmentation suggestive of antimalarial retinopathy occurred in 12%, cornea deposits in 3,1%, and acute visual symptoms in 2.3%. Gastrointestinal affections were detected in 10% of patients: epigastralgia (6%), nausea and vomiting (3.7%) and diarrhea (0.3%). Dermatological affections occurred in 3.4% of patients: skin rash in the beginning of treatment (2%), exacerbation of preexisting psoriasis (0.3%) and skin pigmentation (1.1%). We also detected headache (2.9%), neuromuscular disorders (1.7%) with flu-like episode at the beginning of treatment (1,1%), sensitive neuropathy (0,3%) and myopathy compatible with myasthenia (0.3%) and neuropsychiatric symptoms (0.3%). Discontinuation of drugs owing to side effects occurred in 22.9% of the patients, being that the main affections were eye, gastrointestinal and dermatological occurrences. Ophthalmologic reevaluation of retina pigmentation affections occurred in 12% of the patients, but we confirmed antimalarial retinopathy only in 2.6%, detecting a tendency to value nonspecific, discreet and unilateral affections, which generated unnecessary recommendations for discontinuation of drug in 9.4% of the patients. There were no cases of advanced retinopathy with bull-eye type lesion. There was no statistically significant association between occurrence of adverse effects and retina affections with daily dose per kg of chloroquine diphosphate and the differents types of lupus erythematosus. In patients over the age of 50, there was statistically significant increase in number of retina affections when compared to the group aged below 50 years, possibly owing to difficulty to differentiate between initial affections in antimalarial retinopathy from those resultant from senile macular degeneration. Ophthalmologic control was conducted on average after 10.5 months, showing that annual follow-up was effective to keep track of patients. Nine of the patients were exposed during the first gestational trimester and there were no cases of fetal malformations

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Lima, Alexandre Garcia de. "Estudo dos efeitos da sazonalidade sobre os resultados operatórios e grau de satisfação após simpatectomia videotoracoscópica e do desempenho dos métodos de expansão pulmonar empregados." Universidade de São Paulo, 2011. http://www.teses.usp.br/teses/disponiveis/5/5156/tde-17012013-143803/.

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INTRODUÇÃO: A simpatectomia é o tratamento de escolha para hiperidrose localizada primária. A evolução da técnica visa à melhora dos resultados operatórios e à minimização dos efeitos colaterais, sendo o principal deles o suor reflexo. Esse suor reflexo pode afetar a satisfação em longo prazo, e pode variar conforme as estações do ano, juntamente com a satisfação dos pacientes com os resultados da operação. No entanto, não há dados objetivos quanto ao efeito da sazonalidade sobre os resultados operatórios e sobre os fatores relacionados à satisfação. Os objetivos do presente estudo são: avaliação da variabilidade sazonal sobre o grau das resoluções da sudorese palmar e plantar, bem como a incidência e a intensidade do suor reflexo e análise da influência desses fatores sobre a satisfação; avaliação da dor como fator relacionado à satisfação imediata; avaliação da segurança dos métodos de expansão pulmonar pós-operatória com e sem drenagem pleural e relação dos mesmos à dor. MÉTODOS: Estudo clínico, prospectivo, em duas fases. A primeira, para avaliação de fatores imediatos relacionados à satisfação (fatores antropométricos, dor, presença e intensidade do suor reflexo, grau de resolução da sudorese palma r e plantar, época do ano em que a simpatectomia foi realizada) e segurança dos métodos de expansão pulmonar, cujo desenho é prospectivo, aleatorizado e cego. A segunda, para as avaliações tardias e sazonais dos fatores relacionados à satisfação (fatores antropométricos, presença e intensidade do suor reflexo, grau de resolução da sudorese palmar e plantar), possui desenho prospectivo de coorte. Foram eleitos para o estudo pacientes com hiperidrose palmo-plantar primária submetidos à simpatectomia torácica videoassistida; o período de inclusão foi de 16 meses e o seguimento médio final de 623,63 ± 15,13 dias. Foram então avaliados no período de hospitalização (avaliação da dor, método de expansão pulmonar e do pneumotórax residual) e no sétimo dia de pós-operatório (dor, resultados operatórios e satisfação). Então, tardiamente, na primavera, no verão e no outono/inverno (resultados operatórios e satisfação). Foram considerados resultados operatórios os graus de resolução palmar e plantar e a presença e a intensidade do suor reflexo. Foram estudadas como variáveis independentes relacionadas à satisfação a época do ano onde a simpatectomia foi feita, a dor, os graus de resolução palmar e plantar, presença e intensidade do suor reflexo e fatores antropométricos, a saber, idade, gênero, etnia, índice de massa corporal. RESULTADOS: Foram incluídos 82 pacientes consecutivos, sendo que 80 completaram o seguimento imediato e 75 completaram todo o seguimento. Os resultados operatórios (resolução palmar e plantar, presença e intensidade do suor compensatório) tiveram variação entre todas as estações do ano. A satisfação teve igual variação sazonal e os fatores que estiveram relacionados à queda da satisfação foram distintos, conforme a estação do ano. A drenagem pleural tubular fechada e a expansão com Valsalva foram igualmente eficientes quanto à presença de pneumotórax residual, porém a drenagem pleural em selo d\'água aumentou o tempo cirúrgico e a dor pós-operatória nas primeiras 12 horas; o pneumotórax residual não aumentou a dor. CONCLUSÕES: OS melhores resultados operatórios foram obtidos imediatamente e na primavera, os piores no verão e em nível intermediário no outono/inverno. Na primavera, o único parâmetro relacionado à queda na satisfação foi a não resolução plantar; já no verão e no outono/inverno, foi a presença do suor reflexo, indepedente da sua intensidade. A drenagem pleural tubular fechada teve desempenho inferior à expansão pulmonar sob visão direta com manobra de Valsalva. O pneumotórax residual não influenciou a intensidade dor pós-operatória.
INTRODUCTION: Sympathectomy is the treatment of choice for primary and localized hyperhidrosis. Efforts in evolution of this technique have the aim to improve the surgical results and minimizing the collateral effects, witch told to be the sudomotor reflex. This sudomotor reflex could influence the long term satisfaction; it also could change between the seasons of the year, as well as the satisfaction could change in this matter. However, there is no objective data regarding the influence of the seasonality over the surgical results and satisfaction. The objectives of this study is to assess the seasonal variability of palmar and plantar resolution, as well as the incidence of sudomotor reflex and its intensity; to correlate this factors with satisfaction. To evaluate the pain as a factor related to immediate satisfaction; to assess the safety of lung expansion methods and relate this with postoperative pain. METHODS: A two stage prospective clinical assay. The first stage consists of assessment of the immediate factors related to satisfaction (anthropometrics factors, pain, presence and intensity of the sudomotor reflex, palmar and plantar resolutions, season of the year in witch the operation was performed) and the safety of lung expansion methods; it is a prospective, randomized and blinded study. The second stage is a cohort study, assessing the late factors related to satisfaction (anthropometrics factors, presence and intensity of the sudomotor reflex and palmar and plantar resolutions), under distinct climatic situations. There were included patients with typical palmar and plantar primary hyperhidrosis treated by thoracic video-assisted sympathectomy; the inclusion period was 16 months and the final follow-up time was 623 ± 15,13 days in average. They were assessed in hospital stay (pain, lung expansion technique and residual pneumothorax) and at seventh postoperative day (pain, surgical results and satisfaction). Thereafter they were assessed in spring, summer and autumn/winter (surgical results and satisfaction). The surgical results were palmar and plantar resolutions and presence and intensity of the sudomotor reflex. The independent variables related to satisfaction were season of the year in that the sympathectomy was performed, pain, palmar and plantar resolutions, sudomotor reflex (presence and intensity) and anthropometric parameters (age, gender, ethnics, body mass index). RE8UL T8: 82 consecutives patients were included; thereafter, 80 completed the immediate assess and 75 completed the long term follow-up. The surgical results (palmar and plantar resolutions, presence and intensity of the sudomotor reflex) had significant variation throughout the seasons of the year. Equally, the satisfaction had significant variation, as well as the factor related to dissatisfaction, throughout the seasons of the year. The underwater pleural drainage and the lung expansion with Valsalva maneuver were equally efficient in matter of residual pneumothorax; however the underwater pleural drainage was more painful and more operating time consuming; the residual pneumothorax do not increased the postoperative pain. CONCLUSIONS: The best results are obtained in immediate postoperative period and in spring; the worst results are seen in spring; the intermediate results are obtained in autumn/winter. In the spring, the unique factor related to dissatisfaction was the non resolution of plantar hyperhidrotic symptoms; in the summer and in the autumn/winter the presence of the sudomotor reflex, independently of its intensity, was related to dissatisfaction. The underwater pleural drainage should not be indicating after thoracic video-assisted sympathectomy for lung expansion. The residual pneumothorax does not influence the postoperative pain.

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Bergqvist, Jimmy, and Jens Ingelstedt. "Advertorials; an effective or destructive marketing practice? : The effect of advertorial deception on irritation, credibility, and attitude, both for the advertiser and the advertising medium." Thesis, Internationella Handelshögskolan, Högskolan i Jönköping, IHH, EMM (Entreprenörskap, Marknadsföring, Management), 2010. http://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-14229.

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The thesis explores advertorials, advertising made to look like editorial content, from a consumer behaviour perspective. Introduction Consumers are exposed to a staggering amount of advertisements each day. This so-called advertising clutter makes it difficult for marketers to reach the consumer. Therefore, in the late 1980’s marketers started to use unconventional ways of advertising. One of these was the use of advertorials, a form of advertising that borrows the appearance and other features from editorial material. Problem discussion Since advertorials are made to look like editorial material, but is in reality an advertisement, it is of interest for researchers and practicing marketers alike to know what effects using them has on the brand. Previous research differ in the view on advertorials; some claim that it is a good way to advertise as it is seen as less intrusive and irritating, while others say that the deceptiveness makes people irritated. Purpose Through a quantitative case study of Aftonbladet.se, a Swedish news website, from a consumer perspective analyze the effects the level of deception of online advertorials have on 1) brand credibility, and 2) the irritation level, on both the medium and the advertiser. Also, 3) to thereafter examine if possible alterations in irritation and brand credibility trigger changes in brand attitudes towards medium and advertiser. Background Newspapers have long been dependent on the revenue from advertisement sales, even more so since the emergence of free newspapers and news web sites. With this in mind, the importance of advertorials stands clear. In the on-line world, where readers jump from article to article and from site to site, the advertorials play an important role in “catching” the reader and make him/her stay on the site. Moreover, advertorials is one of the formats of on-line advertising which commands the highest revenues. Frame of reference The on-line context provides additional ways of deceiving a consumer, in comparison with print media. Therefore, the frame of reference focuses on previous research on the effects the deception can have with a consumer and the perception of the brands included; irritation, brand credibility, brand attitude, likeliness to return to site, and advertising avoidance. For later testing, 11 hypotheses were defined. Method The study uses a mixed method approach, with both quantitative and qualitative data. An experiment, with one control group and two different manipulations formed the basis for the data collection. 19 out of the 103 participants in the quantitative study were asked to participate in the qualitative study as well. Analysis As the distribution of the data was found not to be normal, the Kruskal-Wallis test was used to test the hypotheses. All hypotheses but one were accepted. Further, to explore the relationship between variables, hierarchical multiple regression analysis was also performed. Conclusion It was not possible to prove that a higher level of blend-in decreased credibility of any of the two brands, neither does induce more irritation. It was also not possible to discern a statistically significant effect on the attitude towards the brands, likeliness to return to Aftonbladet.se, or future avoidance of adverts by Volvo. However, several of the participants of the interviews expressed concern over the long-term effects the use of advertorials may have on the brand of Volvo. Further, advertorials are definitely highly deceptive, and almost half of the respondents did not realize they were reading an advert even at the lowest level of blend-in, which is currently used by Aftonbladet.se and Volvo.
Avhandlingen utforskar advertorials, reklam kommer att se ut som redaktionellt innehåll, från en konsument beteende perspektiv. Introduktion Konsumenter exponeras dagligen för oerhörda mängder reklam. Detta gör det svårt för marknadsförare att nå konsumenten. Sedan slutet av 1980-talet har vissa marknadsförare därmed börjat använda okonventionella metoder för reklam. En av dessa är användandet av ”dolda annonser”, en form av reklam som lånar utseende och andra funktioner för att smälta in med redaktionellt material i tidningar, på webbsidor och så vidare. Problemdiskussion Eftersom ”dolda annonser” är gjorda för att likna redaktionellt material, men i själva verket är en annonser är det av intresse för både forskare och praktiserande marknadsförare att veta effekterna användandet har på deltagande företags varumärken. Tidigare forskning skiljer sig i synen på dessa ”dolda annonser”, vissa hävdar att det är ett bra sätt att göra reklam, eftersom det ses som mindre påträngande och irriterande, medan andra säger att dess vilseledande natur faktiskt gör människor uppretade. Syfte Genom en kvantitativ fallstudie av Aftonbladet.se, en svensk nyhets-site, från ett konsumentperspektiv analysera effekterna på 1) varumärket trovärdighet, och 2) irritationsnivån, både på annonsorganet och annonsören, när ”dolda annonser” smälter in mer med redaktionellt innehåll. Dessutom, 3) att därefter undersöka om eventuella ändringar i irritation och varumärkestrovärdighet leder till förändringar i attityd mot annonsorganet och annonsören. Bakgrund Tidningar har länge varit beroende av intäkterna från annonsförsäljning. I takt med att framväxten av gratistidningar och nyhets-siter har försvårat marknaden har ”dolda annonser” blivit en allt viktigare inkomstkälla. I den elektroniska världen, där läsare kan hoppa från artikel till artikel och från plats till plats, spelar ”dolda annonser” en viktig roll i att fånga läsaren. Referensram Online-kontextet ger större möjligheter att vilseleda konsumenten i jämförelse med tryckta medier. Därför är den teoretiska tungdpunkten lagd på tidigare forskning om effekterna vilseledande marknadsföring kan ha på en konsuments uppfattning av deltagande varumärken vad gäller irritationsnivå, varumärkestrovärdighet, attityd, sannolikhet att återvända till webbplats, samt reklamundvikande. Ur tidigare forskning konstruerades 11 hypoteser för senare prövning. Metod Studien använder en blandad metodstrategi, med både kvantitativa och kvalitativa data. Ett experiment med en kontrollgrupp och två olika manipulationer låg till grund för insamlingen av uppgifter. 19 av de 103 deltagarna i den kvantitativa delen ombads att delta i den kvalitativa studien med. Analys Eftersom fördelningen inte var helt normalt distribuerad användes Kruskal-Wallis test för att testa hypoteserna. Resultatet var att alla hypoteser utom en godkändes. Relationen mellan variabler undersöktes också genom hierarkisk multipel regressionsanalys. Slutsats Det var inte möjligt att bevisa att annonser som smälter in mer leder till minskad trovärdighet för någon av de båda varumärkena, och inte heller lockar fram mer irritation. Det var inte heller möjligt att urskilja en statistiskt signifikant effekt på attityd gentemot varumärken, sannolikheten att återvända till Aftonbladet.se, eller framtida undvikande av annonser av Volvo. Dock uttryckte flera av deltagarna i intervjuerna oro över de långsiktiga effekterna användning av ”dolda annonser” kan ha på varumärket Volvo. Vidare är definitivt annonserna mycket vilseledande, och nära hälften insåg inte de läste en annons även på nivån som används av Aftonbladet.se och Volvo idag.

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Hou, Ting-Yi, and 侯婷譯. "Study of The Improvement of Docetaxel-Induced adverse Side Effects by Fungal Immunomodulatory Proteins." Thesis, 2014. http://ndltd.ncl.edu.tw/handle/94190937091165475935.

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碩士
中山醫學大學
醫學研究所
102
Docetaxel (TaxotereR) is usually applied in routine chemotherapy. However, the most common side effects of Docetaxel is myelosuppression, include neutropenia and anemia. Fungal Immunomodulatory Proteins of Flammulina velutipes and Ganoderma tsugaeare were called FIP-fve and FIP-gts, respectively. In previous study, both FIP-fve and FIP-gts have immunomodulatory and anti-cancer ability. This study is aimed to investigate the protective function of FIP-fve and FIP-gts on docetaxel-induced adverse side effects. In animal model, complete blood count (Control v Docetaxel) reveals neutropenia (WBC：6.29 ± 1.19 × 103/μL v 3.40 ± 0.74 × 103/μL) and anemia (RBC：9.19 ± 0.52 × 106/μL v 8.06 ± 0.43 × 106/μL). Moreover, FIP-gts but not FIP-fve can reverse docetaxel-induced neutropenia (Docetaxel v Docetaxel combined with FIP-gts，3.40 ± 0.74 × 103/μL v 5.81 ± 1.64 × 103/μL). As compared to Control group (570.38 ± 68.66 μm), histological sections of intestine shows that villous length was decrease in Docetaxel group (365.85 ± 19.21 μm), Docetaxel combined with FIP-fve (474.65 ± 6.8 μm) and Docetaxel combined with FIP-fve (506.60 ± 17.87 μm)), respectively. Consequences, FIP-fve and FIP-gts significantly decreased docetaxel-induced intestine damage. Moreover, numbers of adipocyte (% of control) was significantly increased in Docetaxel group (275.27 ± 45.31%) as compared to Control group (100 ± 22.04%) in bone marrow. FIP-fve (154.84 ± 22.35%) and FIP-gts (138.71 ± 12.35%) can decrease docetaxel-induced adipocyte in bone marrow. Quantification of trabecular bone (Control v Docetaxel) percent bone volume (21.82 ± 1.10% v 11.35 ± 3.32%), trabecular number (3.12 ± 0.26 mm-1 v 1.66 ± 0.45 mm-1), bone surface density (12.20 ± 0.99 mm-1 v 6.82 ± 1.67 mm-1), and trabecular separation (0.21 ± 0.02 mm v 0.379 ± 0.109 mm) analyzed by on 3D micro-CT analysis. This is reason that Docetaxel induced bone damage and increase osteoporosis risk. Moreover FIP-fve and FIP-gts significantly reversed docetaxel-decreased percent bone volume, trabecular number and bone surface density. On the enzyme-linked immunosorbent assay (ELISA), total plasma G-CSF concentration was significantly increased in Docetaxel + FIP-gts group (145.14 ± 76.74 ρg/mL) as compared to Docetaxel group (72.88 ± 39.19 ρg/mL). Both of FIP-fve and FIP-gts can stimulate G-CSF mRNA expression in human peripheral blood mononuclear cells (hPBMCs) by RT-PCR and inhibit A549 cell survival by MTT assay. Both of FIP-fve and FIP-gts reduce the mRNA expression of monocyte chemotactic protein-1 (MCP-1), which promotes lung cancer-induced bone resorptive lesions in A549 lung cancer cells by RT-PCR and ELISA. This is the first study to reveal the novel function of FIP-fve and FIP-gts in mitigating docetaxel-induced adverse side effects. Therefore, we suggest that FIP-fve and FIP-gts may be potential adjuvants of docetaxel.

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Dissertations / Theses on the topic 'Adverse side effects'

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