Journal articles on the topic 'Contraceptive drugs Toxicology'
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1
D'Arcy, P. F. "Drug Interactions with Oral Contraceptives." Drug Intelligence & Clinical Pharmacy 20, no. 5 (May 1986): 353–62. http://dx.doi.org/10.1177/106002808602000504.
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In the very rare cases where a pregnancy occurs during oral contraceptive use, the blame is usually laid against the patient for having forgotten to take the pill. Evidence has started to accumulate to suggest that neither the patient nor the pill is at fault in some contraceptive failures. It may be because the patient is taking other medicines and these may be preventing the pill from suppressing ovulation. Most drug interactions reducing or negating contraceptive activity are due to concomitant use of drugs having microsomal enzyme-inducing activity (e.g., some antibiotics, especially rifampicin, and anticonvulsants, including phenobarbital, Phenytoin, and primidone. Other antibiotics (e.g., tetracycline) may also interact by interruption of the enterohepatic circulation of contraceptive steroids. Less well appreciated, oral contraceptive steroids may themselves modify the metabolism and pharmacological activity of various other drugs (e.g., anticoagulants, benzodiazepines, β-blockers, caffeine, corticosteroids, and tricyclic antidepressants); in this respect the oral contraceptives are acting as enzyme inhibitors. Contraceptive steroids may also interact with drugs that cause enzyme inhibition and this delays the metabolism of the hormonal agents. Interactions of this type would be expected to potentiate the action of the contraceptive steroids. It is suggested that the effects of such interaction might be presented in terms of increased incidence of side effects, including water retention, diabetogenic effects, hypertension, and an increased risk of thromboembolic disorders. The spectrum of interactions with oral contraceptives is presented in three tables.
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SHAMY, Magdy Youssef, Osama El-Sayed SOLIMAN, Hassan Ahmed OSMAN, and Ragaa Mohammed EL-GAZZAR. "Biological Monitoring of Occupational Exposure to Contraceptive Drugs." INDUSTRIAL HEALTH 34, no. 3 (1996): 267–77. http://dx.doi.org/10.2486/indhealth.34.267.
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Venter, Gerda, Carien L. van der Berg, Francois H. van der Westhuizen, and Elardus Erasmus. "Health Status Is Affected, and Phase I/II Biotransformation Activity Altered in Young Women Using Oral Contraceptives Containing Drospirenone/Ethinyl Estradiol." International Journal of Environmental Research and Public Health 18, no. 20 (October 10, 2021): 10607. http://dx.doi.org/10.3390/ijerph182010607.
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Combined oral contraceptive (COC) use has been associated with various adverse effects. Formulations containing drospirenone (DRSP) and ethinyl estradiol (EE) are generally regarded as milder COCs. Whether long term use of these pills indeed has a low health risk remains questionable. COC use may affect the biotransformation balance by increasing the toxic load or by interfering with the pharmacokinetics of other drugs. This may negatively impact overall health via the production of toxic biotransformation metabolites and induction of oxidative stress. Although individual enzymes involved in biotransformation are known to be regulated by COCs, the effect of COC use on the overall liver biotransformation efficiency has not been reported. Here, we evaluated the general subjective health status and overall liver biotransformation efficiency of healthy young women who were either long term chronic users of COCs containing DRSP/EE, or who were not using any hormonal products. COC users suffered from moderate to severe fatigue and reported more health-related symptoms. Furthermore, phase I (CYP1A2) activity was reduced whereas phase II conjugation reactions (glucuronide conjugation and glycine conjugation) were increased in COC users. Finally, serum peroxide levels were markedly elevated and antioxidant capacity of plasma was reduced in COC users. COCs containing DRSP/EE may, therefore, adversely affect health status and disturb the balance between phase I and II biotransformation reactions. These effects may be mediated by oxidative stress.
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Toczek, Jakub, Żaneta Jastrzębska-Stojko, Rafał Stojko, and Agnieszka Drosdzol-Cop. "Endometriosis: New Perspective for the Diagnosis of Certain Cytokines in Women and Adolescent Girls, as Well as the Progression of Disease Outgrowth: A Systematic Review." International Journal of Environmental Research and Public Health 18, no. 9 (April 29, 2021): 4726. http://dx.doi.org/10.3390/ijerph18094726.
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Endometriosis is a common chronic gynecological disorder that undoubtedly impacts on quality of life, and is one of the more complex and mysterious illnesses of our century, which is associated with the improper growth of endometrial tissue outside of the uterine cavity. This pathologically implanted tissue can be found most frequently in the minor pelvis, but also in the peritoneal cavity, and can affect many organs, leading to chronic pelvic pain syndrome, infertility, and dysmenorrhea. Endometrial tissue is a particularly dynamic tissue that has a direct impact on the progression of the disease, with altered immunity, as well as cytokine storms within the metaplastic endometriotic site, as possible key factors. Currently, diagnosis of this mysterious chronic illness relies on performing a laparoscopic procedure with tissue sampling. One of the most troublesome outcomes of this unintended progression is that we lack any specific, sensitive, non-invasive diagnostic tools. Currently, the vast majority of regime stewardship options rely on anti-contraceptive drugs, or other remedies that suppress the release of estrogen through the gonads—although in most clinical trials, endometriosis is a chronic progressive disorder that depends mostly on the high concentration of estrogen. Moreover, many specific trials have demonstrated that the eutopic endometrial cells in individuals with endometriosis remain much more resistant to the immunological annihilation process caused by certain elements of the immune system. Nevertheless, eutopic endometrial cells have the potential to similarly escalate the expression of aromatase receptors on the surface of the pathological cells, which in the final cascade cause an increase in the concentration of estrogen, as well as other inflammatory proteins that contribute to pathological outgrowth. Data reveal occurrence among first-degree relatives, suggesting that the specific cascade could be related to inherited as well as epigenetic (acquired) mechanisms. In women with the disease, confirmed by laparoscopic procedures, diagnosis of endometriosis can be established also via detection by gene polymorphism in the genes which are responsible for responsible for the detoxification phase of estrogen receptors and other immunomodulator components. A recent publication aims to reveal a new prospect for the non-invasive diagnosis, detection, and estimation of certain biomarkers for much more specific investigation of the disease’s progression.
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Ahn, HK, JS Choi, JY Han, MH Kim, JH Chung, HM Ryu, MY Kim, et al. "Pregnancy outcome after exposure to oral contraceptives during the periconceptional period." Human & Experimental Toxicology 27, no. 4 (April 2008): 307–13. http://dx.doi.org/10.1177/0960327108092290.
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To evaluate whether periconceptional exposure to oral contraceptives (OCs) increased adverse pregnancy outcomes, 136 pregnant women taking OCs within the periconceptional period were identified at the Korean Motherisk Program. Of them, 120 pregnant women accepted to participate in their study and were followed up until completion of the pregnancy. A control group of 240 age- and gravidity-matched pregnant women exposed to non-teratogen drugs for at least 1 month before pregnancy was also included. The median gestational age at delivery was 39.1 (27.0–41.0) weeks in the exposed group and 39.3 (27.4–42.0) weeks in the control group ( P = 0.19). In the exposed group, 7.1% of babies were born with low birth weight versus 2.6% in the control group ( P = 0.068). The number of preterm deliveries or babies born large for gestational age did not differ between the two groups. In the exposed group, the rate of birth defects was 3.2% ( n = 3/99) versus 3.6% ( n = 7/193) in the control group ( P = 1.0). There were 15 women who took high doses of progesterone (emergency contraception) and no adverse fetal outcomes were observed. In conclusion, periconceptional exposure to OCs does not appear to increase the risk for adverse pregnancy outcomes.
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Bolt, H. M. "Interactions between clinically used drugs and oral contraceptives." Environmental Health Perspectives 102, suppl 9 (November 1994): 35–38. http://dx.doi.org/10.1289/ehp.94102s935.
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Salas Herrera, I. G., R. M. Pearson, and P. Turner. "Quantitation of Albumin and Alpha-1-Acid Glycoprotein in Human Cervical Mucus." Human & Experimental Toxicology 10, no. 2 (March 1991): 137–39. http://dx.doi.org/10.1177/096032719101000209.
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1 Concentrations of albumin and alpha-1-acid glycoprotein (AGP) in human cervical mucus have been measured by a radial immunodiffusion technique. 2 The cervical mucus samples were obtained from women on combined oral contraceptives (Group A) and from women not taking this medication (Group B). In group A the mean level of albumin was 75.6 (range 22-198) mg 1-1 and for AGP 6.5 (range 3-12) mg 1-1. In group B the mean level of albumin was 72.9 (range 22-148) mg 1-1 and for AGP 6.6 (range 3-14) mg 1 -1. 3 The levels of albumin and AGP in cervical mucus were less than 1% of the concentration in serum and were not affected by combined oral contraceptives. 4 The clinical and toxicological consequences of these observations, in terms of the disposition of drugs and other chemicals in the female genital tract, await elucidation.
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Thomas, John A. "Drugs and Chemicals that Affect the Endocrine System." International Journal of Toxicology 17, no. 2 (February 1998): 129–38. http://dx.doi.org/10.1080/109158198226666.
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The mammalian endocrine system is very dynamic, and undergoes frequent physiological fluctions due to diurnal variations and cyclical hormonal feedback systems. Both hormonal modulations and chemicall drug perturbations can affect the reproductive systems in males and females. An endocrine disrup-tor, a contemporary term that has been used to define an agent that disrupts the endocrine system, is a hormone or antihormone mimic that can modulate endocrine signaling pathways. Unfortunately, this terminology is confusing and ambiguous and fails to account for the ever-changing endogenous hormonal milieu. The endocrine system can be disrupted or modulated by many physiologic events (e.g., exercise, menstruation, pregnancy), by pharm acologic intervention (e.g., oral contraceptives, antithyroidal medication), and by nutritional states (e.g., iodine deficiencies, vitamin deficiencies and malnutrition). Seasonal changes (e.g., light and temperature) can also modulate endocrine events. Phytoestrogens and xenoestrogens (e.g., chlorinated pesticides) can also affect the dynamics of the endocrine system. Heavy metals and certain anti-cancer agents can interfere with testicular and ovarian function and may cause sterility. Several sites of action can be involved between a drug/chemical and the endocrine system, including the central nervous system, specific target organs or subpopulation of cells, hormone-transporting proteins, and xenobi-otic-m etabolizing enzymes in the liver. At the endocrine target organ level, mechanism(s) of action may involve competition for a cell receptor or affect non-receptor-mediated actions. Some drug!chemicals may act as hormone agonists (i.e., mimic) or conversely act as hormone antagonists (i.e., an antihormone); other agents may act as partial agonists or partial antagonists. Clearly, there are many internal and external factors that can modulate the endocrine system, yet the paracrine and autocrine regulation of specific target organs is finely regulated, and, importantly, is very resilient to drugl chemical perturbation.
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Wiseman, H. M., K. Guest, V. S. G. Murray, and G. N. Volans. "Accidental Poisoning in Childhood: A Multicentre Survey. 1. General Epidemiology." Human Toxicology 6, no. 4 (July 1987): 293–301. http://dx.doi.org/10.1177/096032718700600406.
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1 As background to a study of the effectiveness of packaging in preventing childhood poisoning, the National Poisons Information Service coordinated a prospective survey, in which 9 Accident and Emergency (A & E) departments and 5 paediatric departments, between July 1982 and February 1984, recorded 2043 cases of suspected accidental poisoning in children aged 0-60 months. 2 The products implicated were drugs (59%), household products (37%) and plants (3%). The drugs most frequently implicated were analgesics, anxiolytics, cough medicines, oral contraceptives and drugs to supplement diet or treat dietary disorders. The most frequently implicated household products were cleaners such as bleach, detergent and disinfectant, and petroleum distillate. 3 Seventy-five per cent of the children were 2 and 3-year-olds. Fifty-six per cent were male. 4 Only 22% of the children had signs or symptoms on admission. In only 2 cases were these serious. Treatment other than ipecacuanha and/or oral fluids was seldom required. Of the cases where outcome was recorded, 56% were discharged from A & E. The rest were admitted to a ward; only 7 children were admitted to intensive care units. No child died. 5 Comparison with HASS and other epidemiological surveys shows that these results are representative of national trends.
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Vesell, Elliot S. "Implications for Risk Assessment of Host Factors Causing Large Pharmacokinetic Variations." Toxicology and Industrial Health 1, no. 4 (October 1985): 135–52. http://dx.doi.org/10.1177/074823378500100409.
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Normal human subjects vary widely in their capacity to eliminate many drugs and environmental chemicals. These variations range in magnitude from fourfold to fortyfold depending on the drug and the population studied. Pharmacogenetics deals with only one of many host factors responsible for these large pharmacokinetic differences. Age, sex, diet and exposure to other drugs and chemicals, including oral contraceptives, ethanol and cigarette smoking, can alter the genetically determined rate at which a particular subject eliminates drugs and environmental chemicals. These elimination rates, therefore, are dynamic and change even in the same subject with time and condition. Regulatory legislation has only recently begun to recognize this very broad spectrum of human susceptibility and the existence of multiple special subgroups of particularly sensitive subjects. In setting standards for environmental chemicals, EPA and NIOSH have attempted to protect the most sensitive humans and should be encouraged to continue this policy. For some drugs and environmental chemicals, the commonly used safety factor of 100 may be too low; for these chemicals large, interindividual pharmacokinetic variations produced by pharmacogenetic and other host factors may make a safety factor of 400 or 500 more adequate.
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Rauber, Claudia, Micheli Regina Feltrin, and Anna Paula Piovezan. "Evaluation of antibiotics dispensing profile in Tubarão, Santa Catarina, Brazil." Brazilian Journal of Pharmaceutical Sciences 45, no. 4 (December 2009): 787–93. http://dx.doi.org/10.1590/s1984-82502009000400024.
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Antibiotics are drugs widely used in prophylaxis and treatment of a great number of diseases. However, their use must be carefully controlled as acquisition in pharmacies, often without medical prescription, is elevated. The role of pharmacists in these circumstances is to practice dispensation in a rational manner. Through a structured questionnaire with open and closed questions, this study investigated the profile of antibiotics dispensed in pharmacies of Tubarão, Santa Catarina, Brazil. From the responses, it was observed that 85.0% dispense this class of medicine without medical prescription, mainly for treatment of respiratory (62.8%) and urinary (12.0%) tract disorders. Moreover, pharmacists' guidance was largely focused on posology (66.6%) and drug interaction (12.6%), in addition to the interactions with contraceptives, alcohol and milk. The importance of avoiding antibiotics dispensation without medical prescription must be emphasized, as well as the benefits of educating the population to promote the rational use of medicines.
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Srivastava, Amita, Sharda Shah Peshin, Thomas Kaleekal, and Suresh Kumar Gupta. "An epidemiological study of poisoning cases reported to the National Poisons Information Centre, All India Institute of Medical Sciences, New Delhi." Human & Experimental Toxicology 24, no. 6 (June 2005): 279–85. http://dx.doi.org/10.1191/0960327105ht527oa.
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A retrospective analysis of poisoning calls received by the National Poisons Information Centre showed a total of 2719 calls over a period of three years (April 1999-March 2002). The queries were made on poisoning management (92%) and information (8%) about various products and functioning of the centre. The data were analysed with respect to age, sex, mode and type of poisoning. The agents belonged to various groups: household products, agricultural pesticides, industrial chemicals, drugs, plants, animal bites and stings, miscellaneous and unknown groups respectively. The age ranged from less than 1 to 70 years, with the highest incidence in the range of 14-40 years, with males (57%) outnumbering females (43%). The most common mode of poisoning was suicidal (53%), followed by accidental (47%). The route of exposure was mainly oral (88%). Dermal (5%), inhalation and ocular exposure contributed 7% to the total. The highest incidence of poisoning was due to household agents (44.1%) followed by drugs (18.8%), agricultural pesticides (12.8%), industrial chemicals (8.9%), animals bites and stings (4.7%), plants (1.7%), unknown (2.9%) and miscellaneous groups (5.6%). Household products mainly comprised of pyrethroids, rodenticides, carbamates, phenyl, detergents, corrosives etc. Drugs implicated included benzodiazepines, anticonvulsants, analgesics, antihistamines, tricyclic antidepressants, thyroid hormones and oral contraceptives. Among the agricultural pesticides, aluminium phosphide was the most commonly consumed followed by organochlorines, organophosphates, ethylene dibromide, herbicides and fungicides. Copper sulphate and nitrobenzene were common among industrial chemicals. The bites and stings group comprised of snake bites, scorpion, wasp and bee stings. Poisoning due to plants was low, but datura was the most commonly ingested. An alarming feature of the study was the high incidence of poisoning in children (36.5%). The age ranged from less than 1 to 18 years and the most vulnerable age group included children from less than 1 year to 6 years. Accidental mode was the most common (79.7%). Intentional attempts were also noticed (20.2%) in the age group above 12 years. The present data may not give an exact picture of the incidence of poisoning in India, but represents a trend in our country. The Poisons Information Centre plays a vital role in providing timely management guidelines including the supply of necessary antidotes from the recently established National Antidote Bank, thereby helping to save precious lives.
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Yous, Tamara, Esther Spinatsch, Samuel Allemann, and Monika Lutters. "Development of a Protocol Using the Delphi Method for the ad interim Supply of Hormonal Contraceptives in Swiss Pharmacies." Pharmacy 10, no. 6 (December 2, 2022): 168. http://dx.doi.org/10.3390/pharmacy10060168.
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(1) Background: Pharmacists are often challenged with situations where women are already on hormonal contraceptives (HC) but have no valid prescription. By Swiss law, pharmacists are allowed to supply prescription-only drugs in exceptional situations without a physician’s prescription. Because eligibility for HC can change, women at risk for complications, such as serious side effects, need to be identified. We aimed to develop a protocol to assist pharmacists in clarifying and documenting eligibility for HC. (2) Methods: We conducted a survey using the Delphi method to identify relevant clarifications and develop a protocol for pharmacists. Proposed material was created based on the literature and existing toolkits/protocols aimed at verifying eligibility for HC. A multidisciplinary expert panel, consisting of gynecologists and pharmacists, reviewed the proposed material and provided anonymized feedback over two survey cycles. (3) Results: This Delphi survey revealed items essential to the clarification of eligibility for HC in pharmacies for women who are already using it. This resulted in a protocol that maps “best practices” regarding these ad interim supplies of HC given without a prescription in Switzerland. (4) Conclusions: This survey, made using the Delphi method, allowed us to create a protocol for pharmacists that aims to verify and document eligibility for HC in Switzerland, where HC is frequently supplied without a prescription.
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Kretova, Irina G., Olga V. Belyaeva, Olga A. Vedyasova, and Snezhanna I. Pavlenko. "The analysis of students' attitude to healthy lifestyle and reproductive health care." Hygiene and sanitation 101, no. 9 (September 30, 2022): 1080–85. http://dx.doi.org/10.47470/0016-9900-2022-101-9-1080-1085.
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Introduction. In connection with low competency of young people in the issue of life safety it is relevant to analyze entirely the students` attitude to healthy lifestyle. Also it is important to assess the students` knowledge about reproductive health and ways of keeping it well. Materials and methods. The authors undertook questionnaire method and asked anonymously seven hundred sixty three students of Samara National Research University. Survey consists of 38 questions regarding students` age, leisure time, academic performance and influence of the process of education on health, family social status, attitude to sport, psychoactive substances. Also students were asked about their knowledge of healthy lifestyle components, sexually transmitted infections, possibility of prevention and contraception. Results. The authors found out that young men do sports more often than girls. Also boys use more often cold training and eat regularly. Every tenth girl has a lack sleep, sleep duration is less than 5-6 hours. 30% of boys and girls drink alcohol two or three times a month, 35% of students smoke. 12.45% of young people (men and women) experimented with drugs. Peculiarities of students`sexual behaviour are early beginning of sexual intercourse and frequent changing of sexual partners. The authors revealed low level of students` knowledge about contraception, sexually transmitted infections and its sequela, preventive measures. Limitations. Only students of Samara National Research University were involved into this investigation except students of Biology Faculty (because they are more informed in the field of healthy life style and reproductive health) and students who do sports professionally or who have chronic diseases. Conclusion. The problem of reproductive health care and primary prevention of sexually transmitted infections can`t be solved only by medical staff. Correction of risky behaviour is an interdisciplinary challenge that demands comprehensive approach focused on group and social norm changing. Universities must play an important role in this issue making it possible for professors to have classes of academic discipline such as «Family health», « Fundamentals of Medicine» where qualified professors with higher medical education can discuss with students the issue of reproductive behavior.
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Gentner, Bernhard, Francesca Farina, Matteo Giovanni Carrabba, Magda Marcatti, Stefania Girlanda, Gabriele Antonarelli, Capotondo Alessia, et al. "TEM-MM-101: A Phase I/IIa Dose Escalation Study Evaluating the Safety and Activity of Autologous CD34+ Enriched Hematopoietic Progenitor Cells Genetically Modified for Human Interferon-α2 in Multiple Myeloma Patients with Early Relapse after Intensive Front Line Therapy." Blood 134, Supplement_1 (November 13, 2019): 2064. http://dx.doi.org/10.1182/blood-2019-123749.
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BACKGROUND Multiple Myeloma (MM) is an incurable malignancy heralded by an immunosuppressive tumor microenvironment (TME). Therapeutic efforts to reprogram the TME and release innate and adaptive immunity may synergize with current anti-MM drugs, deepen responses and ultimately prolong long-term survival. We have developed an ex vivo gene therapy approach that locally delivers interferon-alpha (IFNa) into the TME through the Tie2+ myeloid progeny of transplanted gene-modified hematopoietic stem and progenitor cells (HSPCs). Preclinical studies in the immunocompetent Vk*Myc murine model as well as in the hematochimeric xenotransplantation setting demonstrate that IFNa gene therapy has anti-MM effect and may subvert the immunosuppressive MM TME, acting both on myeloma cells as well as on the immune infiltrate. Additional toxicology data, demonstrates that a mixture of genetically modified and unmodified CD34+ cells can be transplanted safely. We have therefore progressed into the clinic at Ospedale San Raffaele in Milan, Italy, with our gene therapy approach (Temferon). METHODS The TEM-MM-101 study recruits patients with MM in early relapse (within 18 months) after intensive front line therapy defined as triplet induction (at least 3 cycles including a proteasome inhibitor and/or immunomodulatory drug [IMID]) followed by single or double autologous stem cell transplantation, or, triplet or quadruplet induction including at least a proteasome inhibitor and an IMID, followed by consolidation/maintenance treatment. Three cohorts of 3 patients will be included in the study. Patients will be dosed sequentially in each cohort with data review by an independent data monitoring committee before dose escalation to the next cohort. Key eligibility criteria include achieving at least a VGPR after second line salvage therapy, age 18-70 years, ECOG <2 and Karnofsky >70%, adequate cardiac, renal, hepatic and pulmonary function, and willingness to use appropriate contraception if relevant. Important exclusion criteria include the presence of active autoimmune disease or ineligibility for autologous bone marrow transplant. After confirmation of eligibility, patients undergo autologous peripheral blood HSPC mobilization with lenograstim and plerixafor, before undergoing apheresis. After purification, CD34+ cells undergo transduction with a third-generation, vesicular stomatitis virus-G pseudo-typed lentiviral vector driving myeloid-specific IFNa2 expression. Patients will be offered maintenance treatment from successful HSPC collection until Temferon release. A reduced intensity conditioning regimen is administered at Day -2 followed by ASCT and administration of Temferon at Day 0. Following hematological recovery, patients will be discharged from the Transplant Unit with regular outpatient follow up. After Day +100 from Temferon infusion, patients will resume anti-myeloma consolidation/maintenance treatment according to best clinical practice, unless there is Temferon engraftment and absence of disease on Day +100 evaluations, documented by stringent complete response (sCR) according to the IMWG response criteria, imaging (PET, MRI) negativity, and bone marrow minimal residual disease < 10-4 by multi-parameter flow cytometry, to be confirmed by next generation sequencing. If these response criteria are met on Day +100, patients may stay off maintenance treatment, as long as MRD≤10-5 documented on bone marrow aspirates performed every 3 months, starting from the Day +180 visit. The primary endpoints for this study are: Engraftment of Temferon between Day +30 and Day +100The proportion of patients achieving hematologic recovery by Day +30 from ASCTSafety of Temferon (short-term tolerability of Temferon; stable blood counts and absence of cytopenias > grade 2, unless related to myeloma progression or concomitant medications; absence of systemic IFNa toxicity; absence of Replication Competent Lentivirus; absence of hematologic malignancy that is distinct from progression of the primary neoplasm) The study is actively recruiting patients in Italy. In parallel, a study using Temferon in patients with glioblastoma multiforme with a similar study design and approach (TEM-GBM-001) is also in progress with the first cohort fully recruited. Disclosures Gentner: Genenta Science: Consultancy, Equity Ownership, Research Funding. Mazzoleni:Genenta Science: Employment, Equity Ownership. Russo:Genenta Science: Consultancy, Equity Ownership. Naldini:Genenta Science: Consultancy, Equity Ownership; Magenta Therapeutics: Equity Ownership; San Raffaele Telethon Institute for Gene Therapy (SR-TIGET), a joint venture between Fondazione Telethon and Ospedale San Raffaele (OSR): Other: Wiskott-Aldrich Syndrome (WAS) gene therapy was licensed to GlaxoSmithKline (GSK) in 2014. It was then licensed to Orchard Therapeutics (OTL) in April 2018. OTL is the current sponsor of the clinical trial..
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Shafiq, Mamoona, Erum Afaq, Tooba Zafar, Mehwish Qamar, Saima Qureshi, and Amna Faruqi. "Exogenous Progesterone Produces Significant Histomorphological Changes in the Lungs of Experimental BALB/c Mice." Pakistan Journal of Medical and Health Sciences 16, no. 8 (August 30, 2022): 338–41. http://dx.doi.org/10.53350/pjmhs22168338.
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Background: Progesterone is used in combined oral contraceptive pills and also has its effect on the respective receptors which are responsible for sexual development. Bronchial asthma emerges to be a major health issue in Pakistan with estimated prevalence is about 5% of the total population. Epidemiological studies highlight that one of the considerable risk factor for morbidity and mortality in inflammatory lung diseases is female gender. This suggests that sex-related hormones might play an imperative role in asthma disease progression. Understanding the biological role of sex hormones in regulating airway inflammation is crucial given the rising prevalence of chronic diseases among women worldwide. Aim: To determine the effect of progesterone on lungs of adult male mice by assessing and comparing the histological parameters e.g. bronchiolar smooth muscle size and peri-bronchial lymphocytic infiltration. Study Design: Randomized control trial Place and Duration of Study: Department of Physiology, Islamabad Medical & Dental College Islamabad in collaboration with National Institute of Health Islamabad from 1st October 2018 to 31st July 2019. Methodology: Sixty BALB/c mice were divided into 2 groups and each group comprised 30 mice. Group I (control group) received only distilled water and group 2 (norethisterone BP group) received pills mixed in distal water according to body weight of the mice respectively for 60 days. Results: In response to progesterone, 30% of the total mice had nil, 40% had mild, 26.7% of the total who showed moderate while severe PBLI was observed in 3.3% of the mice. Different frequencies of Bronchiolar Smooth Muscle Hyperplasia were observed when compared to Control group. Mild to moderate hyperplasia was produced by progesterone (norethisterone BP) group. Conclusion: Progesterone is the sexual hormone which modulates inflammatory processes in the lungs producing pulmonary inflammatory responses leading to asthma and also causes hyperplasia of the bronchiolar smooth muscles. Keywords: Progesterone, Asthma, Bronchiolar smooth muscle, Peri-bronchial lymphocytic Infiltration, BALB/c mice
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Khosla, Gayatri, Vikram Sharma, and Vikesh Kumar Shukla. "A Review on Birth control: Natural source as Anti-fertility agents." Research Journal of Pharmacy and Technology, July 29, 2022, 3331–37. http://dx.doi.org/10.52711/0974-360x.2022.00557.
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The population is increasing at a steady rate worldwide and it is now identified as one of the main threats to our planet in the 21st century. Since ancient times herbal medicines have been used for fertility regulation in males and females. Antifertility agents and contraceptive agents are the drugs that hinder the process of fertilization through barrier as well as the anti-fertility effects. Contraception involves the methodology of preventing the normal process of ovulation by affecting the menstrual cycle, fertilization, and ovulation. One example of birth control pills is progesterone and estrogen in combination. Anti-fertility component noticed as an active agent in females for prevention of fertilization and in case of males, prevention of spermatogenesis by inhibiting testosterone or action on the gonadotropin of organs or mortality of sperms. Numerous plants have phytoestrogens as novel agents which have noxious effects by making changes in the normal gestation procedure and lead to impaired fertility in domestic animals. Various experimental models have been developed and evidenced for evaluating the efficacy of antifertility agents. The review provides a comprehensive summary of contraceptive methods used in males and females, various plants, parts of plants and extracts are been used for the facilitation of anti-fertility have used as anti-fertility agents. Moreover highlighted old and presently used experimental models for the evaluating the anti-fertility agents.
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Shah, Manan, and Charmy Kothari. "Comparative Safety Assessment study for Drospirenone Induced Gallbladder Diseases using the Adverse Drug Reaction Database of USA, Europe, and Canada." Current Drug Safety 15 (October 27, 2020). http://dx.doi.org/10.2174/1574886315999201027150243.
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Background: Gallstone disease (GSD) is one of the most common gastroenterological disorders. It is known that Drospirenone causes small increased risk of gallbladder diseases. But the risk may varies among different adverse drug reaction database. Objective: To examine the safety and risk association between hormonal contraceptive Drospirenone and gallbladder diseases using adverse drug reaction database of USFDA’s Federal Adverse Events Reporting System (FAERS), Europ’s Eudravigilance (EV) and Canada’s Canada Vigilance Adverse Reaction Online Database (CVARD). Methods: Individual Case Safety Reports of patients till October 2019 were downloaded from the Federal Adverse Event Reporting System, Eudravigilance, and Canadian database. These reports contain information on adverse events associated with all other drugs inclusive of Drospirenone. The disproportionality method of data mining was used to calculate the risk association. Results: The lower limit of 95 % CI of PRR was 3.27, 3.47 and 3.76, PRR was 33.08, 41.35 and 115.42, ROR was 37.20, 44.61 and 127.19, Chi-square value was 126572.89, 110392.95 and 362.46, and IC-2SD value is 0.16, 0.17, and 1.21 for FAERS, EU, and CVARD respectively indicating a week signal. Also, all the calculated parameters are above the threshold value. Conclusion: From our study, it is clear that the risk between drospirenone and gallbladder diseases is very low among three databases. There is no harm in prescribing this drug for a contraceptive action.
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Liao, Mingxiang, Krzysztof G. Jeziorski, Monika Tomaszewska-Kiecana, István Láng, Marek Jasiówka, Viera Skarbová, Piotr Centkowski, et al. "A phase 1, open-label, drug–drug interaction study of rucaparib with rosuvastatin and oral contraceptives in patients with advanced solid tumors." Cancer Chemotherapy and Pharmacology, August 9, 2021. http://dx.doi.org/10.1007/s00280-021-04338-7.
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Abstract Purpose This study aimed at evaluating the effect of rucaparib on the pharmacokinetics of rosuvastatin and oral contraceptives in patients with advanced solid tumors and the safety of rucaparib with and without coadministration of rosuvastatin or oral contraceptives. Methods Patients received single doses of oral rosuvastatin 20 mg (Arm A) or oral contraceptives ethinylestradiol 30 µg + levonorgestrel 150 µg (Arm B) on days 1 and 19 and continuous doses of rucaparib 600 mg BID from day 5 to 23. Serial blood samples were collected with and without rucaparib for pharmacokinetic analysis. Results Thirty-six patients (n = 18 each arm) were enrolled and received at least 1 dose of study drug. In the drug–drug interaction analysis (n = 15 each arm), the geometric mean ratio (GMR) of maximum concentration (Cmax) with and without rucaparib was 1.29 for rosuvastatin, 1.09 for ethinylestradiol, and 1.19 for levonorgestrel. GMR of area under the concentration–time curve from time zero to last quantifiable measurement (AUC0–last) was 1.34 for rosuvastatin, 1.43 for ethinylestradiol, and 1.56 for levonorgestrel. There was no increase in frequency of treatment-emergent adverse events (TEAEs) when rucaparib was given with either of the probe drugs. In both arms, most TEAEs were mild in severity and considered unrelated to study treatment. Conclusion Rucaparib 600 mg BID weakly increased the plasma exposure to rosuvastatin or oral contraceptives. Rucaparib safety profile when coadministered with rosuvastatin or oral contraceptives was consistent with that of rucaparib monotherapy. Dose adjustments of rosuvastatin and oral contraceptives are not necessary when coadministered with rucaparib. ClinicalTrials.gov NCT03954366; Date of registration May 17, 2019.
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SHARAFI, MITRA. "Abortion in South Asia, 1860–1947: A medico-legal history." Modern Asian Studies, May 4, 2020, 1–58. http://dx.doi.org/10.1017/s0026749x19000234.
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Abstract In the progression of stages toward unintended lives, the two stops on either side of abortion—contraception and infanticide—have been studied extensively by historians of South Asia. We know much less about abortion, particularly during the colonial period. Drawing upon published judgments, unpublished case records, forensic toxicology reports, and treatises on Indian medical jurisprudence, this article suggests that anti-abortion law was generally enforced in colonial India only when women died as a result of illegal abortions. This approach was contrary to the Indian Penal Code (IPC), which criminalized most abortions even when the women survived. The pattern was a continuation of the pre-IPC approach in India. This article explores possible explanations for the lax enforcement of anti-abortion law in South Asia during the late nineteenth and early twentieth centuries, considering abortion as experienced by South Asian and British women alike. It proposes as contributing factors: challenges in detection, the social movement for the protection of Hindu widows, colonial anxieties about false allegations of abortion among South Asians, the common phenomenon of imperial (British) husbands and wives living apart, and physicians’ desire to protect doctor–patient confidentiality. The article focuses on two key cases involving abortion: the Whittaker-Templeton case from Hyderabad (1896–1902) in which a British woman died following an abortion; and the Parsi matrimonial case of T. v. T. from Bombay (1927), in which a Zoroastrian woman alleged that her pharmacist husband had forced her to terminate three pregnancies by ingesting drugs.