Tesis sobre el tema "Enteral formulae"

A procedure for preparing an enteral formula was developed, using Pakistani indigenous food items. The basis of development was that it would be nutritionally effective, easy to prepare and relatively cheap. 100 indigenous enteral diets were formulated using a computer aided master sheet in which various combinations were analysed. In order to prove the efficacy of these diets, a modified PER was carried out on 6 diets and results indicated a higher PER for the experimental diet. 29 formulations were shortlisted for preparation trials, and 2 main techniques were applied: incubation and cooking techniques. Physical and chemical analyses were carried out to assess the effect of preparation, the cooking methodologies were tried on various diets and 2 diets were shortlisted for human trials. To compare the efficacy of the indigenous enteral formula versus commercial formulae, a pilot study was carried out. Patient nutritional outcomes were assessed using biochemical parameters, and preliminary findings indicated that the experimental diet performed as well as the control diet.
Doctor of Philosophy (PhD)

A procedure for preparing an enteral formula was developed, using Pakistani indigenous food items. The basis of development was that it would be nutritionally effective, easy to prepare and relatively cheap. 100 indigenous enteral diets were formulated using a computer aided master sheet in which various combinations were analysed. In order to prove the efficacy of these diets, a modified PER was carried out on 6 diets and results indicated a higher PER for the experimental diet. 29 formulations were shortlisted for preparation trials, and 2 main techniques were applied: incubation and cooking techniques. Physical and chemical analyses were carried out to assess the effect of preparation, the cooking methodologies were tried on various diets and 2 diets were shortlisted for human trials. To compare the efficacy of the indigenous enteral formula versus commercial formulae, a pilot study was carried out. Patient nutritional outcomes were assessed using biochemical parameters, and preliminary findings indicated that the experimental diet performed as well as the control diet.

Thesis (MNutr (Human Nutrition))--University of Stellenbosch, 2006.
INTRODUCTION: The primary objective was to determine whether acidified formulae (pH 3.5 and 4.5) decreased gastric and tracheal colonisation, as well as microbial contamination of the enteral feeding delivery system, compared with a non-acidified control formula (pH 6.8) in critically ill patients. Secondary objectives included tolerance of the trial formulae and mortality in relation to the administration of acidified formulas. DESIGN: The trial was a controlled, double-blinded, randomised clinical trial of three parallel groups at a single centre. METHOD: Sixty-seven mechanically ventilated, medical and surgical critically ill patients were randomised according to their APACHE II scores and included in the trial. Patients received either an acidified (pH 3.5 or 4.5) or control polymeric enteral formula via an 8-Fr nasogastric tube at a continuous rate. Daily samples were taken for microbiologic analyses of the enteral formulae at various stages of reconstitution and at 6-hour and 24-hour intervals during administration thereof (feeding bottle and delivery set). Daily patient samples included nasogastric and tracheal aspirates, haematological evaluation and gastro-intestinal tolerance. The trial period terminated when patients were extubated, transferred from the ICU, enteral nutrition became contraindicated, a patient died, or for a maximum of 21 days. RESULTS: Gastric pH showed no significant difference (p = 0.86) between the 3 feeding groups [pH 3.5 (n = 23), pH 4.5 (n = 23) and pH 6.8 (n = 21)] at baseline prior to the administration of enteral formulae. After initiation of feeds, the gastric pH decreased significantly (p< 0.0001) in the acidified formulae as compared to the control formula during the trial period. Patients who received acidified enteral formulae (pH 3.5 and 4.5) had significantly less (p < 0.0001) contamination from the feeding bottles and delivery systems in respect of Enterobacteriacea, and Enterococcus., The more acidified group (pH 3.5) showed significantly less gastric contamination (p = 0.029) with Enterobacteriacea, , but not for fungi. The 3.5 acidified group also had the lowest gastric growth in terms of colony counts (≤104) of these organisms, but not for fungi, when compared to the control group (≤105). Vomiting episodes were 22% and abdominal distension 12%, with a higher incidence in the control group. Adverse events occurred equally between the groups with a higher, but not significantly different incidence of 37% in the control group and 32% for the acidified groups. There was no evidence of gastro-intestinal bleeding in any patient. Overall, the mortality rate in this trial was 6%, with 6.5% for the acidified groups (n=46) and 4.8% for the control group (n=21), a statistically insignificant difference. CONCLUSION: Acidified enteral formulae significantly decrease gastric colonisation by preserving gastric acidity that decreases the growth of Enterobacteriaceaes organisms. Acidified formulae significantly decrease bacterial contamination of the enteral feeding system (bottle and delivery set) of Enterobacteriaceae and Enterococcus organisms. Acidified formulae are tolerated well in critically ill patients.

Orientador: Maria Antonia Martins Galeazzi
Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Engenharia de Alimentos
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Resumo: O objetivo deste trabalho, foi avallar a eficiência terapêutica de uma dieta enteral, formulada com hidrolisado protéico de soja na recuperação de pacientes desnutridos. O hidrolisado foi obtido por processo enzimático descontínuo em reator de hidrólise, com controle de pH durante a reação, concentração do substrato 5,0% e relação E/S 1:20, e 6h de duração. O rendimento do processo foi elevado, sendo determinado pelo nitrogênio solúvel em TCA a 10%, que foi 79,81% e o nitrogênio do sobrenadante após a centrifugação do produto final foi de 85,35%. Pela cromatografia de exclusão molecular observou-se alto rendimento em peptídeos de baixo peso. Na avallação da eficiência nutricional a dieta formulada com o hidrolisado na recuperação de ratos wistar adultos desnutridos, foi idêntica à que seria utilizada com humanos, variando-se apenas a composição de minerais, que foram adicionados de acordo com as necessidades de ratos adultos, segundo AIN-93. Os animais recuperaram o peso na mesma velocidade e proporção dos animais controle, sob dieta de caseína. A recuperação do peso foi muito rápida até a 3ª semana, quando então os animais mantidos com a dieta de HPS se igualaram ao controle. Os parâmetros sanguíneos analisados revelou plena recuperação com todas as dietas experimentais, porém ficou evidente a superioridade do hidrolisado. Os estudos de perfusão, feitos para verificar a eficiência na absorção pelas estruturas intestinais de animais desnutridos e posteriormente recuperados, não revelou diferença entre os grupos, demonstrando que o hidrolisado foi eficientemente absorvido, mesmo pela mucosa de ratos desnutridos. A histologia do fígado e do intestino de animais mantidos sob dieta a protéica e depois recuperados com as dietas experimentais, demonstrou danos moderadamente severos provocados pela desnutrição, e a recuperação com a dieta contendo o hidrofisado foi semelhante aos animais do grupo controle, tanto para as estruturas do fígado como do intestino. A dieta formulada para recuperação de pacientes desnutridos continha: 16,0% de proteína na forma de hidrolisado de soja, 24,0% de lipídio composto por gordura de coco, 60,0% de carboidratos, fornecidos pela maltodextrina, e minerais e vitaminas para cobrir as necessidades recomendadas pela ROA (1989). A análise sensorial da dieta pelo teste afetivo indicou que o sabor inviabilizaria o seu uso por via oral. Os pacientes receberam a dieta por via enteral, através de sondas nasogástricas e jejunal. Foram alimentados 8 pacientes hospitalizados, sendo 75,0% considerados moderadamente desnutridos e 25,0% severamente desnutridos. A duração média do tratamento foi de 12 dias, e durante este período verificou-se aumento de peso, elevação nos índices de albumina, transferrina, proteínas totais, e balanço nitrogenado positivo. Não foram observados a ocorrência de cólicas abdominais, vômitos ou diarréias. Conclui-se diante destes resultados que a dieta enteral formulada com hidrolisado protéico de soja, tanto na recuperação de animais, como de pacientes desnutridos, demonstrou eficiência e ausência de sintomas adversos
Abstract: The aim of this work was to evaluate the therapeutic efficiency of an enteral diet formulated with soy protein hydrolyzate on the recovery of starving patients. The hydrolysate was obtained by descontinuous enzymatic process in a hydrolysis reactor under pH control, substrat concentration of 5% and EIS relation of 1 :20, during six hours. The output of the process was elevated this was determined by soluble nitrogen in a TCA at 10% which was 79,81 %; and the nitrogen of the suspended final material after centrifugation, which was 85,35%. The chromatography by molecular exclusion indicated output in low weight peptides. Evaluation of the nutritional efficiency of the formulated diet with the hydrolysate, on the recovery of starving adult wistar rats, was identical to that used with humans, varying only the mineral composition, which was added according to the necessitites of adults rats, following the AIN-93. The animals recovered their weight in the same velocity and proportion of the control animals. under a casein diet. The animals maintained with a HPS diet reveled full recovery with all the experimental diets. although it was evident the superiority of the hydrolysate. The blood parameters verified in the experiment with animals revealed suitable recuperation with all the experimental diet. Studies of perfusion, done to verify the efficiency in the absorption by the intestinal structures of starving animals and afterwards recovered, did not revel differences among groups, demonstrating that the hydrolysate was efficiently absorbed, even by the mucous of starving rats. Liver and intestine of animals maintained under non protein diet. and afterwards recovered with the experimental diets, demonstrated moderately severe damages provoked by starvation, and recovery with the hydrolysate diet was similar to the group of control animals for both the liver and the intestine structures. Diet formulated to recover de starving patients contained: 16% of protein in the form of soy hydrolysate; 24% of lipids formed by coconut fat; 60% of carbohydrates furnished by maltodextrins; and minerals and vitamins sufficient to cover the RDA (1989) recommendations. Sensorial analyses of the diet by the likeability test indicated that flavor would impair the use of oral diet. Patients received an enteral diet through nasogas1ric and enteral tube. Eight hospitalized patients were fed, of whom 75,0% were considered to be starving moderately and 25,0% were starving severely. The average period of treatment was 12 days. During this time a weight gain was observed, as well as an elevation of the albumin, transfenin, total Protein levels and a positive nitrogen balance. It was not observed the onset of abdominal pain, vomits, or diarrhea. According to these results, it is possible to conclude that the formulated diet with soy Protein hydrolysate was efficient to recover animal as well as starving patients without adverse symptoms
Doutorado
Doutor em Ciência da Nutrição

O objetivo geral deste trabalho foi elaborar formulados alternativos, à base de mistura de alimentos convencionais, provenientes da cesta básica distribuída por entidades do município de Piracicaba-SP, entre outros alimentos, com o intuito de suplementar a alimentação enteral de idosos. Os alimentos utilizados para a elaboração dos formulados foram fubá, óleo de soja, arroz, feijão, macarrão, sardinha, leite em pó, amido de milho, ovos, proteína texturizada de soja, couve- manteiga e cenoura. Foram realizadas análises físicas: gotejamento e viscosidade; análises químicas: composição centesimal, digestibilidade de proteína, determinação do mineral ferro, diálise de ferro in vitro, determinação de -caroteno e fatores antinutricionais, assim como fenólicos totais e ácido fítico; análises microbiológicas: Salmonella, Bacillus cereus, Estafilococos coagulase positiva e Coliformes totais; análise de custos dos formulados e elaboração do manual de boas práticas de manipulação. Os resultados obtidos foram submetidos às análises estatísticas, empregando-se o teste de Tukey, utilizando o software SAS (1996) e análises de regressão, pelo programa Microsoft Office Excel (2003). Concluiuse, com esse estudo, que os formulados líquidos apresentaram os melhores resultados nutricionais, físicos, microbiológicos, e a maior viabilidade econômica, sendo, por isso, sugeridos para a suplementação enteral de idosos. Dentre eles, pode-se eleger uma entre duas alternativas, conforme a necessidade clinica do idoso, considerando-se todos os aspectos nutricionais e físicos dos formulados. O formulado F3 destacou-se nas seguintes características: disponibilidade de ferro, quantidades de -caroteno, digestibilidade, viscosidade e gotejamento. Já o formulado F4 teve destaque na distribuição do valor calórico total de macronutrientes, apresentando valores ideais para os idosos, segundo as recomendações internacionais, além do maior valor calórico entre os formulados e boa viscosidade e gotejamento. No que diz respeito ao valor calórico total, os formulados apresentaram de 131 a 216 calorias por 250ml, os tratamentos líquidos apresentaram valor calórico superior ao dos formulados em pó. Pode-se dizer que os formulados contribuem com percentual médio de 20% de adequação, em relação às recomendações de macronutrientes sugeridas pela DRI (2002) para idosos, quando ingeridas duas porções de 250mL/dia de formulados líquidos ou em pó.
The aim of this study was to develop alternative formulas for elderly enteral feeding using conventional foods from food staples distributed in the city of Piracicaba-SP. The foods used in the formulas were: corn meal, soya oil, rice, beans, pasta, sardine, powder milk, corn starch, eggs, texturized soya protein, cabbage, and carrot. Physical analyses (dripping and viscosity), chemical analyses (centesimal composition, protein digestibility, iron determination, iron dialyses in vitro, -carotene determination, anti-nutritional factors - tannins and phytate), microbiological analyses (Salmonella, Bacillus cereus, positive Staphylococcus coagulase and total Coliforms), cost analyses and elaboration of a manual for good manipulation practices were carried out. Results were analyzed statistically using Tukey test, SAS software (1996) and for regression using Microsoft Office Excel (2003). Liquid formulas presented better nutritional, physical and microbiological results as well as economical viability Therefore were suggested for elderly enteral nourishment. According to the elderly clinical needs, two alternatives are suggested among liquid formulas. The F3 formula is noticeable for iron availability, quantity of -carotene, digestibility, dripping and viscosity. The F4 formulas is noticeable for the total calorie distribution of macronutrients as well as for having a higher number of calories and good viscosity and dripping which is ideal for the elderly, according to international recommendations. The formulas presented a range of 131 to 216 calories/250ml. Liquid formulas presented higher number of calories than powder formulas. The formulas contributed with a 20% adequacy regarding to macronutrient recommendations for the elderly from DRI (2002), when two servings of 250mL.day-1 (powder or liquid) were ingested.

The advanced glycation endproducts (AGEs) constitute a large variety of compounds formed from nonenzymatic amino-carbonyl interactions between reducing sugars or oxidized lipids and proteins, nucleic acids or aminophospholipids. The AGEs formation in foods and biological systems is a topic of increasing interest for the science, since they are involved in proinflammatory and pro-oxidative effects related to the pathogenesis of chronic degenerative diseases such as diabetes, Alzheimer's disease and renal failure. The Nε-carboxymethyllisine (CML) was the first AGE identified in foods and, since then, has been the compound of choice in studies on which a single product is used as an AGE marker. Immunochemical or instrumental methods are available for the AGEs determination, but they present limitations and there is not an ideal method yet. Thus, in order to compare and optimize different analytical methods, this study aimed to determine the CML content on enteral and parenteral nutrition formulas by ELISA and LC-MS/MS. So, in order to compare and optimize different analytical methods, this study aimed to determine the content of CML in nutritional enteral and parenteral formulas by ELISA and by liquid chromatography coupled to tandem mass spectrometry (LC-MS / MS). Thus, 5 parenteral and 17 enteral commercially available formulations were investigated. All samples studied showed detectable levels of CML, regardless of the method of analysis used. The parenteral formulations presented CML contents measured by ELISA ranging from 529.9 ± 33.47 to 1948.88 ± 3.68 ng CML/mL of sample and showed positive linear correlations to their content in lipids (0.9259) and carbohydrates (0.9426), but they were not submitted to the LC-MS/MS analysis due to the impossibility of applying the established purification protocol for this group of samples. Enteral formulations analyzed by ELISA presented CML contents ranging from 1076.91 ± 76.87 to 55950.71 ± 1891.29 ng CML/mL of sample and showed positive correlations to its contents in carbohydrate (0.6057), lipid (0.5264) and protein (0.6157). They showed a variation from 0.09 to 0.503 μg CML/mg of protein of the diets when analyzed by LC-MS/MS and there was no correlation between CML and the variables "lipid", "carbohydrate" or "protein" calculated for this group. The investigation conducted during the samples preparation prior to injection into the LC-MS/MS showed a significant loss of CML during the different stages of the protocol, compromising the reliability of the results obtained through this method of analysis, while the comparison between the results obtained through different methods applied to similar samples showed the reliability of the anti-CML ELISA test used in this experiments. The results of this study indicate the need for improvement of AGEs analysis protocols in food and should guide future research on this area. The determination of reliable methods of detection, which enable the measurement of AGEs structures in body fluids, tissues and also in food, in a sensitive, specific, fast and not too expensive way is a challenge that remains present on this field.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Os produtos da glicação avançada (AGEs, do inglês Advanced Glycation Endproducts) constituem grande variedade de substâncias formadas a partir de interações amino-carbonilo, de natureza não-enzimática, entre açúcares redutores ou lipídeos oxidados e proteínas, aminofosfolipídeos ou ácidos nucléicos. A formação de AGEs nos alimentos e em sistemas biológicos constitui tema de crescente interesse, desde que estão associados a efeitos pró-oxidativos e pró-inflamatórios envolvidos na patogênese de diversas doenças crônico-degenerativas como o diabetes, o mal de Alzheimer, a insuficiência renal. A Nε-carboximetilisina (CML) foi o primeiro AGE a ser identificado em alimentos e tem sido o composto de escolha em estudos em que um único produto é usado como marcador de AGEs de um sistema. Métodos imunoquímicos ou instrumentais estão disponíveis para a determinação da CML, mas ambos apresentam limitações, não havendo ainda um método considerado ideal. Assim, a fim de comparar e otimizar diferentes métodos analíticos, o presente estudo teve como objetivo determinar o conteúdo em CML de fórmulas nutricionais enterais e parenterais através das técnicas de ELISA e de cromatografia líquida acoplada à espectrometria de massa tandem (LC-MS/MS). Para tanto, foram investigadas 5 formulações parenterais e 17 enterais comercialmente disponíveis. Todas as amostras investigadas apresentaram níveis detectáveis de CML neste estudo, independentemente do método de análise utilizado. As fórmulas parenterais apresentaram conteúdos mensurados através de ELISA que variaram de 529,9 ± 33,47 a 1948,88 ± 3,68 ng de CML/mL de amostra e apresentaram correlações lineares positivas quanto aos seus conteúdos em lipídeos (0,9259) e em carboidratos (0,9426), mas não foram submetidas às análises através do LC-MS/MS devido à inviabilidade da aplicação para esse grupo de amostras do protocolo de purificação estabelecido nesta investigação. As formulações enterais apresentaram conteúdos em CML que variaram entre 1076,91 ± 76,87 e 55950,71 ± 1891,29 ng de CML/ mL de amostra e evidenciaram correlações positivas quanto aos seus conteúdos em carboidratos (0,6057), lipídeos (0,5264) e proteínas (0,6157), quando analisadas através de ELISA, e apresentaram uma variação de 0,09 e 0,503 μg CML/ mg de proteína das dietas quando analisadas através do LC-MS/MS, não havendo correlações entre a CML e as variáveis “lipídeos”, “carboidratos” ou “proteínas” para esse grupo. A investigação conduzida durante o processo de preparo das amostras, anterior à injeção no LC-MS/MS, evidenciou uma expressiva perda da CML durante as diferentes etapas do protocolo, comprometendo a confiabilidade dos resultados obtidos através desse método de análise, enquanto a comparação entre os resultados encontrados através dos diferentes métodos aplicados a amostras semelhantes em composição e preparo demonstrou a confiabilidade do teste de ELISA anti-CML utilizado nas condições deste experimento Os resultados do presente estudo apontam a necessidade de aperfeiçoamento dos protocolos de análise de AGEs em alimentos e deverão guiar futuras investigações nesta área. Dentre os desafios que permanecem presentes no campo de estudo dos AGEs está a definição de métodos de detecção confiáveis, que possibilitem a mensuração de estruturas nos fluidos ou tecidos corporais e nos alimentos, de maneira sensível, específica, rápida e não muito dispendiosa.

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A Terapia Nutricional Enteral em pacientes hospitalizados exige comprometimento e capacitação de todos os envolvidos nesse processo. Além disso, as dietas enterais devem ser seguras quanto aos aspectos nutricionais e higiênico-sanitário, garantindo a recuperação dos pacientes e a qualidade do serviço prestado. Este estudo teve como objetivo avaliar a qualidade físico-química e microbiológica de uma dieta enteral industrializada, assim como avaliar as Boas Práticas em Nutrição Enteral de uma unidade hospitalar do sul do Rio Grande do Sul. Foi selecionada a marca da dieta enteral industrializada mais prescrita aos pacientes adultos da Clínica Médica da unidade hospitalar. Essa marca foi analisada quanto a sua composição centesimal para comparação com as informações do rótulo, quanto a sua esterilidade comercial e quanto ao nível de contaminação microbiana quando manipulada e distribuída na unidade hospitalar. Os pontos amostrais da dieta manipulada foram analisados para mesófilos aeróbios, coliformes a 35°C e a 45°C, Escherichia coli, Estafilococos coagulase positiva, Salmonella sp., bolores e leveduras. A água proveniente da torneira e do filtro do lactário, utilizada para hidratação de pacientes em Nutrição Enteral e para o transporte das dietas, foi analisada quanto a sua potabilidade. A estrutura e os processos em Nutrição Enteral da Unidade Hospitalar também foram analisados quanto a sua adequação às Boas Práticas de Preparação e Administração em Nutrição Enteral, que seguiu a Resolução da Diretoria Colegiada nº 63/2000, da Agência Nacional de Vigilância Sanitária. Na análise laboratorial da composição centesimal, foi encontrado um déficit de 31,9% de lipídeos, que influenciou nos resultados de carboidratos e calorias. O teste de esterilidade comercial das dietas enterais revelou alterações físicas no produto e contagem de bolores e leveduras acima do permitido pela legislação específica. As amostras da dieta manipulada mostraram-se dentro dos limites recomendados pela legislação para a maioria micro-organismos analisados, exceto para mesófilos aeróbios, bolores e leveduras. A maioria das amostras de água analisadas era potável, exceto uma amostra da água utilizada para o transporte da dieta. O resultado da análise da adequação às Boas Práticas de Preparação em Nutrição Enteral e para as Boas Práticas de Administração em Nutrição Enteral foi de 59,5% e de 43,2%, respectivamente. Concluiu-se que a real composição de nutrientes não esta de acordo com a informação nutricional do produto, o produto encontrou-se impróprio para consumo quando hermeticamente fechado e quando manipulado, e que a unidade hospitalar necessita de um maior controle de seus processos em Nutrição Enteral e de adequações às legislações vigentes.
The Enteral Nutrition Therapy in hospitalized patients requires training and commitment of everyone involved in this process. In addition, enteral feeding should be held regarding the nutritional and hygienic- sanitary aspects, ensuring the recovery of patients and quality of service. This study aimed to evaluate the physicochemical and microbiological quality of an enteral diet industrialized as well as evaluating the Enteral Nutrition Practice in a hospital in southern Rio Grande do Sul brand enteral feeding was selected industrialized most prescribed to adult patients of the Medical Clinic of the hospital. This mark was analyzed for its chemical composition for comparison with the label information, as their commercial sterility and the level of microbial contamination when handled and distributed at the hospital. The sampling points of manipulated diet were analyzed for aerobic mesophilic, coliform bacteria at 35°C and 45°C, Escherichia coli, coagulase positive staphylococci, Salmonella sp., Molds and yeasts. The water from the tap and filter lactary used for hydration of patients enteral and to transport the diets was analyzed for its potability. The structure and processes in Enteral Nutrition Unit of the Hospital were also analyzed for its suitability to Good Practice for Preparation and Administration Enteral Nutrition, which followed the Board Resolution No. 63/2000, the National Health Surveillance Agency. In laboratory analysis of the chemical composition, found a deficit of 31,9% lipids, which influence the results of carbohydrates and calories. Testing for commercial sterility of enteral diets showed physical changes in product and mold and yeast counts above those permitted by specific legislation. Samples of manipulated diet were within the limits recommended by the legislation for most micro -organisms analyzed except for mesophilic aerobic, yeasts and molds. Most of the water samples analyzed was drinking except a sample of the water used to transport the diet. The result of the analysis of compliance with Good Practice in Preparation for Enteral Nutrition and Good Management Practices in Enteral Nutrition was 59.5% and 43.2%, respectively. It was concluded that the actual nutrient composition is not according to the nutritional information on the product, the product was found unfit for consumption when tightly sealed and when manipulated, and that the hospital needs more control of its processes in Nutrition enteral and adaptations to existing laws.

碩士
大仁科技大學
藥學系碩士班
107
Probiotic is an important kind of microorganism modifier which plays a very important role on the physical health of intestinal tract. Probiotics not only regulate microenvironment of gut, provide energy to gut, but also induce the mucosal, humoral and cellular immunity in intestinal tract to protect human body. In this research the enteric formula was prepared by first making the probiotic bacteria Clostridium butyricum crystal ball into millions of spherical ingots by extrusion technology, then film-coating the spherical ingot separately with five different thicknesses of control-release layers. The film-coated spherical ingots were then mixed with enteric polymer material, binders and disintegrating agents, and were then subjected to wet granulation and tableting. These enteric tablets were evaluated for dissolution in simulated gastric fluid and simulated intestinal fluid. The experimental results show that the dissolution profile of the enteric formula at the same pH value varied with various processes and formulation parameters, including the size of the crystal sphere, the thickness of the coating on the probiotic crystal ball ingot, and the mass ratio of the enteric coating material. It was also found that the dissolving solutions affect the release profile of probiotic. In this study, it was found that thicker coating on the probiotic crystal ball ingots tended to maintain better appearance of the enteric tablet after dissolution test in the simulated gastric fluid. Overall, the formula with thicker coating on the probiotic crystal ball ingots seems to maintain more stable release of probiotic. It is also learned from this research that by adjusting the suitable process parameters, both the release profile and the stability of the drug can be manipulated, so that the drug can be prevented from cracking and agitation in the stomach, and the drug can be released after reaching the intestinal site.

碩士
靜宜大學
食品營養研究所
91
The purpose of this study was to assess the outcomes of enteral immune –enhancing formula in severe burned patients. From August 1998 until October 2002 , 21 burned patients from Burn Center of National Cheng Kung University hospital were randomized to receive early enteral nutrition with a enteral enhaning - immune formula（experimental n=11）or a high protein enteral formula.（control：10）Various nutritional, clinical, urinary, immunologic parameters were observed on postburned day 2, 4, 7, 14. Data analysis were performed by student t- test. , paired t- test and chi-square. Result：After 12 days of feeding the two groups had increased in energy ,protein, arginine and glutamine intake. Patients receiving “enteral enhaning-immune formula” experienced significantly better gastrointestinal tolerance than control group (p<0.05)，increase of serum prealbumin different between postburned day 7and day 14. (p<0.05) , and serum transferrin on postburned day 7. (p<0.05) In conclusion, this trial suggested this “enteral enhaning-immune formula” offer clinical benefits in severe burned patients. Key words：severe burned patients、enteral enhaning-immune formula 、gastrointestinal tolerance、mortality

Background: Ventilator associated pneumonia (VAP) is a major cause of morbidity, longer intensive care unit (ICU) stay, increased duration of mechanical ventilation, and increased healthcare cost in critically ill patients. Critically ill patients are at increased risk for malnutrition, which is associated with impaired immune function, impaired ventilator drive and weakened respiratory muscles. Malnutrition has been thought to increase the risk of VAP due to bacterial translocation from the gastrointestinal tract to the lungs. Previous research that has evaluated the effect of enteral nutrition on malnutrition associated with VAP has been inconsistent in part because of the subjectivity of the old definition of VAP. In 2013, the Center for Disease Control and Prevention (CDC) developed a new definition for the diagnosis of VAP, which includes three tiers of a ventilator associated event (VAE); ventilator associated condition, infection-related ventilator-associated complication, or possible or probable VAP). The purpose of this study is to retrospectively examine the relationship between enteral formula, tube-feeding placement site, time of tube feeding initiation and the incidence of VAE using this new CDC definition. Objective: The aim of the study was to retrospectively examine the relationship between enteral formula, tube-feeding placement site, time of tube feeding initiation and the incidence of VAE using this new CDC definition. Participants/setting: The medical records of 162 adult patients admitted to one of the ICUs (Medical ICU, Surgical ICU, Neurological ICU, Burn ICU) at Grady Memorial Hospital (GMH) in Atlanta, GA in 2013 Main outcome measures: Demographic and baseline medical characteristics including the type of enteral formula used (standard, immune-modulating, hydrolyzed, immune-modulating and hydrolyzed, or mixed), enteral tube feeding placement (gastric or small bowel), and timing of enteral nutrition (never fed, fed48 hours after admission) were collected. Statistical analysis: Demographic and baseline medical characteristics were described using frequency statistics and compared by VAE status using the Mann-Whitney U and Kruskal-Wallis tests. The relationship between tube placement, enteral formula, timing of feeding and the diagnosis of a VAE was evaluated using the Chi-square test. Results: In 2013, 81 patients admitted to the ICU at GMH were diagnosed with a VAE. The median age of the study population (n=162) was 50 years (range, 19 to 88 years) and the median BMI was 27.6 kg/m2 (range, 13.2 to 83.2 kg/m2). The majority of the population was African American (53.1%) and male (64.2%). Most patients were fed through a gastric tube (86.4%), were given an immune-modulating enteral formula (32.1%) and were fed after 48 hours of admission (44.4%). After subdividing by ICU location, 12 of 14 patients (86%) in the Medical ICU who were diagnosed with a VAE were either never fed or fed >48 hours after admission vs. 7 of 13 (54%) of patients in the Medical ICU who were not diagnosed with a VAE (p=0.031). No other relationships between the type of feeding initiation, tube placement, and enteral formula were found by VAE status for the population or by ICU location. Conclusion: Adults admitted to the Medical ICU may have a reduced risk of developing a VAE if fed within 48 hours of admission. The type of enteral formula provided and the route of administration was not associated with the diagnosis of VAE. Future prospective studies should include all critical care patients to further evaluate the effect of nutrition on VAE outcome.

碩士
臺北醫學大學
保健營養學系
94
The purpose of this study was to investigate the effect of enteral feeding with Eicosapentaenoic acid (EPA), γ-linolenic acid (GLA) and antioxidants (Vitamin A, C, E) in burn patients using mechanical ventilation. Method: 43 burn patients who were using mechanical ventilation on admission were randomized. The study group was tube fed with EPA, GLA and antioxidants enriched formula and the control group was tube fed with iso-nitrogenic and iso-caloric formula. Blood samples were drawn on admission days 1, 8, and 15 for tumor necrosis factor-α(TNF-α), interleukin 6 (IL-6) and interleukin 10 (IL-10) tests. Cytokines, respiratory function, ventilator setting and outcome were measured. Results: There were 10 patients in the study group and 13 patients in the control group who went through the 8th day study course. Five patients in the study group and 9 patients in the control group complete the 15-day course. There was no significant differences for either calorie or protein intake between the study and control groups. Though the intake of EPA (5.2+1.5g Vs 0g)、GLA(5.2+1.5g Vs 0g)、vitamin E (362+112 IU Vs 97+115 IU)、vitamin C (965+298 mg Vs 478+260 mg) and vitamin A (13727+298 IU Vs 5840+447 IU) were significantly higher in the study group (p < 0.001), there were no significant differences for TNF-α, IL-6, IL-10, respiratory function, ventilator setting and length of hospital stay between the two groups, except minute ventilation in the study group. Conclusion: Except minute ventilation, there was no significant effect on cytokines, ventilatory variables and outcome for enteral feeding with EPA、GLA and antioxidants enriched formula in burn patients using mechanical ventilation.

碩士
朝陽科技大學
應用化學系碩士班
94
This research uses one kind of hydroxy propyl methylcellulose (Hypromellose Acetate Succinate, AS-LF) as the superposition colloid of the enteric coated hard capsules. Formula proportion：ethyl alcohol 76%, methylene chloride 11%, and AS-LF powder 13%. The hard capsules were moistened in formula solution at the temperature approximately 33℃. Then dry approximately 5 minutes at 35 ℃ following cold wind for about 10 minutes. The superposition colloid prepared by this partition controls temperature dryness process, can form am egual thickness membrane on the capsule with approximately 0.025g increase. On the disintegration tester, this researched enteric coated hard capsules can stay in the simulation gastric juice (0.1N HCl, approximately pH = 1.2) for two hours insoluble. (pH ~ 6.8) The capsule finally collapse during two minutes in the leaning alkalinity solution and releases the content. The methylene chloride residue test, shows it，s concentration is lower than detection limit.By theory calculation each capsule may contain methylene chloride lower then 0.34 ppm. It is safe may in the edible scope. In the stability test of the membrane, the capsules were stored for two months, three months, and 17 months before the disintegration test. The results expressed the hard capsule with super position volloid membrane may preserve at least a year and ahalf.

碩士
朝陽科技大學
應用化學系碩士班
95
This research uses hydroxypropyl methylcellulose acetate succinate﹙HPMCAS﹚ to made the intestine dissolved colloid as the coating material of the hard capsule. The purpose of this coating is using its characteristic to prevent the aspirin capsule breaking up in the stomach, until the capsule migrate to intestine and breaks up to the drug. The aspirin would not to injure the stomach by this way. The research including the discussion of the intestine dissolved colloid formula, the disintegration test and, the dissolution test of capsules, as well as the stability of the enteric coated capsules, and its comparison with aspirin enteric coated tablet in drugstore. The experimental results showed that in the colloid formula the dichloromethane can reduce to 9%. All results of disintegration tests, the dissolution tests, and the stability tests of the aspirin enteric-coated capsules conforms to the stipulation of pharmacopoeia, therefore the edible aspirin enteric coated hard capsules may have the same curative effect, and reduce the risk of side effects. The correlation coefficients of linear calibration in this analysis method for aspirin and salicylic acid are 0.9994 and 0.9999. The relatively standard deviation﹙R.S.D﹚of the specific and accuracy test obtained are both below 1.5%. The experimental results the high of sensitivity and fast detection of aspirin and the salicylic acid also proves the feasibility of this analysis method.

碩士
臺北醫學大學
保健營養學系
93
The proposed study was to assess the effectiveness of enhanced fish oil immune enteral feeding formula on the immune responses of patients with abdominal surgery. The patients were divided into two groups, one group was administrated with fish oil enhanced IMPACT-Glutamine® (n=7) formula, another group was given the commercial formula Alitraq® without fish oil (n=7). Two groups were treated with isocalorie (30 kcal/Kg body weight) condition. The APACHE II Score of patients were less than 15. The immune responses (i.e., CD4, CD8, CD4/CD8, C3, C4, and NBT test), the nutrition status (i.e. albumin, prealbumin), and digestion condition (i.e. frequency of diarrhea) of two groups were evaluated before feeding and fed on day 7, respectively. In results, there were no statistical differences before treatment on immune responses and albumin except prealbumin in two groups. The prealbumin level of control group was significant higher than the IMPACT-Glutamine® group (p = 0.028) before treatment. However after administration, the prealbumin (p = 0.043) and C3 (p = 0.018) were significant higher than before treatment in the Alitraq® group. The IMPACT-Glutamine® group was no significant differences between before and after administration in immune response and nutrition status. Five patients fed with enhanced fish oil formula had serious diarrhea. None of the patients presented diarrhea in Alitraq® group. In conclusion, the IMPACT-Glutamine® fish oil enhanced formula did not present the postive immune response of patients with abdominal surgery and resulted in serious diarrhea.