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1.
Nutrients ; 10(7)2018 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-29941818

RESUMO

International scientific experts in food, nutrition, dietetics, endocrinology, physical activity, paediatrics, nursing, toxicology and public health met in Lisbon on 2⁻4 July 2017 to develop a Consensus on the use of low- and no-calorie sweeteners (LNCS) as substitutes for sugars and other caloric sweeteners. LNCS are food additives that are broadly used as sugar substitutes to sweeten foods and beverages with the addition of fewer or no calories. They are also used in medicines, health-care products, such as toothpaste, and food supplements. The goal of this Consensus was to provide a useful, evidence-based, point of reference to assist in efforts to reduce free sugars consumption in line with current international public health recommendations. Participating experts in the Lisbon Consensus analysed and evaluated the evidence in relation to the role of LNCS in food safety, their regulation and the nutritional and dietary aspects of their use in foods and beverages. The conclusions of this Consensus were: (1) LNCS are some of the most extensively evaluated dietary constituents, and their safety has been reviewed and confirmed by regulatory bodies globally including the World Health Organisation, the US Food and Drug Administration and the European Food Safety Authority; (2) Consumer education, which is based on the most robust scientific evidence and regulatory processes, on the use of products containing LNCS should be strengthened in a comprehensive and objective way; (3) The use of LNCS in weight reduction programmes that involve replacing caloric sweeteners with LNCS in the context of structured diet plans may favour sustainable weight reduction. Furthermore, their use in diabetes management programmes may contribute to a better glycaemic control in patients, albeit with modest results. LNCS also provide dental health benefits when used in place of free sugars; (4) It is proposed that foods and beverages with LNCS could be included in dietary guidelines as alternative options to products sweetened with free sugars; (5) Continued education of health professionals is required, since they are a key source of information on issues related to food and health for both the general population and patients. With this in mind, the publication of position statements and consensus documents in the academic literature are extremely desirable.


Assuntos
Bebidas/normas , Qualidade de Produtos para o Consumidor/normas , Inocuidade dos Alimentos , Alimentos/normas , Adoçantes não Calóricos/normas , Adoçantes Calóricos/normas , Valor Nutritivo , Animais , Bebidas/efeitos adversos , Glicemia/metabolismo , Consenso , Diabetes Mellitus/sangue , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/terapia , Ingestão de Energia , Alimentos/efeitos adversos , Rotulagem de Alimentos/normas , Humanos , Adoçantes não Calóricos/efeitos adversos , Adoçantes Calóricos/efeitos adversos , Obesidade/epidemiologia , Obesidade/fisiopatologia , Obesidade/terapia , Recomendações Nutricionais , Medição de Risco , Perda de Peso
2.
Nutr Hosp ; 33(4): 400, 2016 Jul 19.
Artigo em Espanhol | MEDLINE | ID: mdl-27571675

RESUMO

Introducción:la nutrición parenteral (NP) a largo plazo puede asociarse a complicaciones graves, con un deterioro importante de la calidad de vida de los pacientes con síndrome de intestino corto (SIC). Teduglutida, un análogo del péptido-2 similar al glucagón, pertenece a una nueva familia terapéutica y representa el primer abordaje no sintomático del SIC. Objetivos: revisar los datos preclínicos y clínicos en cuanto a eficacia y seguridad de teduglutida. Resultados: la aprobación de teduglutida se basó en los resultados de un estudio en fase III de 24 semanas, doble ciego, controlado con placebo (STEPS). Pacientes con fallo intestinal por SIC dependientes de NP ≥ 3 veces/semana durante ≥ 12 meses recibieron 0,05 mg/kg de teduglutida (n = 43) o placebo (n = 43) 1 vez/día. En la semana 24 hubo significativamente más respondedores en el grupo de teduglutida que en el de placebo (63 vs.30%; p = 0,002). La reducción absoluta media del volumen de NP frente al valor basal en la semana 24 fue significativamente mayor con teduglutida (4,4 vs.2,3 l/semana; p < 0,001). La necesidad de NP se redujo ≥ 1 día en la semana 24 en el 54% de pacientes tratados con teduglutida vs.23% con placebo. Del total de pacientes que recibieron teduglutida en los ensayos en fase III (n = 134), el 12% consiguió una autonomía completa de la NP. Por lo general, la administración subcutánea de teduglutida se toleró bien. Conclusiones: se ha demostrado que teduglutida recupera la absorción intestinal y reduce significativamente la dependencia de la NP, consiguiendo incluso la independencia en algunos pacientes.


Assuntos
Fármacos Gastrointestinais/uso terapêutico , Peptídeos/uso terapêutico , Síndrome do Intestino Curto/tratamento farmacológico , Animais , Fármacos Gastrointestinais/farmacocinética , Fármacos Gastrointestinais/farmacologia , Humanos , Peptídeos/farmacocinética , Peptídeos/farmacologia
3.
Nutr. hosp ; 33(4): 969-977, jul.-ago. 2016. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-154927

RESUMO

Introducción: la nutrición parenteral (NP) a largo plazo puede asociarse a complicaciones graves, con un deterioro importante de la calidad de vida de los pacientes con síndrome de intestino corto (SIC). La teduglutida, un análogo del péptido-2 similar al glucagón, pertenece a una nueva familia terapéutica y representa el primer abordaje no sintomático del SIC. Objetivos: revisar los datos preclínicos y clínicos en cuanto a eficacia y seguridad de la teduglutida. Resultados: la aprobación de la teduglutida se basó en los resultados de un estudio en fase III de 24 semanas, doble ciego, controlado con placebo (STEPS). Pacientes con fallo intestinal por SIC dependientes de NP ≥ 3 veces/semana durante ≥ 12 meses recibieron 0,05 mg/kg de teduglutida (n = 43) o placebo (n = 43) 1 vez/día. En la semana 24 hubo significativamente más respondedores en el grupo de la teduglutida que en el de placebo (63 s. 30%; p = 0,002). La reducción absoluta media del volumen de NP frente al valor basal en la semana 24 fue significativamente mayor con la teduglutida (4,4 vs. 2,3 l/semana; p < 0,001). La necesidad de NP se redujo ≥ 1 día en la semana 24 en el 54% de pacientes tratados con teduglutida vs. 23% con placebo. Del total de pacientes que recibieron teduglutida en los ensayos en fase III (n = 134), el 12% consiguió una autonomía completa de la NP. Por lo general, la administración subcutánea de teduglutida se toleró bien. Conclusiones: se ha demostrado que teduglutida recupera la absorción intestinal y reduce significativamente la dependencia de la NP, consiguiendo incluso la independencia en algunos pacientes (AU)


Introduction: Long-term Parenteral Support (PS) can be associated with serious complications, with a significant deterioration in the quality of life of patients with short bowel syndrome (SBS). Teduglutide is a recombinant analogue of glucagon-like peptide-2; it belongs to a novel therapeutic family and represents the first non-symptomatic approach against SBS. Objectives: To review the non-clinical and clinical data on efficacy and safety of teduglutide. Results: Teduglutide approval was based on results from a pivotal Phase III, 24-week, double-blind, placebo-controlled study (STEPS). SBS patients dependent on PS ≥ 3 times/week for ≥ 12 months received 0.05 mg/kg teduglutide (n = 43) or placebo (n = 43) 1 time/day. At week 24 there were signifi cantly more responders in the teduglutide group vs. placebo (63 vs. 30%; p = 0.002). The overall mean reduction vs. PS baseline volume at week 24 was significantly higher with teduglutide vs. placebo (4.4 vs. 2.3 l/ week, p < 0.001). At week 24 the need for PS was reduced in at least 1 day in 54% of patients treated with teduglutide vs. 23% with placebo. Of the total of patients who received teduglutide in phase III trials (n = 134), 12% achieved complete autonomy from PS. Subcutaneous teduglutide was generally well tolerated. Conclusions: Teduglutide has been shown to enhance intestinal absorptive capacity and signifi cantly reduce PS dependency, even achieving independency in some patients (AU)


Assuntos
Humanos , Masculino , Feminino , Síndrome do Intestino Curto/tratamento farmacológico , Síndrome do Intestino Curto/epidemiologia , Síndrome do Intestino Curto/prevenção & controle , Peptídeo 2 Semelhante ao Glucagon/metabolismo , Peptídeo 2 Semelhante ao Glucagon/uso terapêutico , Nutrição Parenteral Total/métodos , Nutrição Parenteral Total , Nutrição Parenteral/instrumentação , Nutrição Parenteral/métodos , Nutrição Parenteral , Nutrição Parenteral/tendências , Soluções de Nutrição Parenteral/uso terapêutico , Qualidade de Vida , Peptídeo 2 Semelhante ao Glucagon/farmacologia , Peptídeo 2 Semelhante ao Glucagon/farmacocinética , Posologia/normas
4.
Obes Surg ; 26(8): 1836-42, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-26661106

RESUMO

BACKGROUND: Specific data is needed to safely expand bariatric surgery and to preserve good surgical outcomes in response to the non-stop increase in obesity prevalence worldwide. OBJECTIVE: The aims of this study are to provide an overview of the baseline characteristics, type of surgery, and 30-day postoperative morbidity and mortality in patients undergoing bariatric surgery in Spanish public hospitals, and evaluate changes throughout the 2000-2014 period. MATERIAL AND METHODS: This is a descriptive study using data from the RICIBA, a computerized multicenter and multidisciplinary registry created by the Obesity Group of the Endocrinology and Nutrition Spanish Society. Three periods according to the date of surgery were created: January 2000 to December 2004 (G1), January 2005 to December 2009 (G2), and January 2010 to December 2014 (G3). RESULTS: Data from 3843 patients were available (44.8 ± 10.5 years, a 3:1 female-to-male ratio, 46.9 ± 8.2 kg/m(2)). Throughout the 15-year period assessed, candidate patients for bariatric surgery were progressively older and less obese, with an increase in associated comorbidities and in the prevalence of men. The global trend also showed a progressive decrease in Roux-en-Y gastric bypass, the most performed bariatric procedure (75.1 % in G1, 69.3 % in G2, and 42.6 % in G3; p < 0.001), associated with a parallel increase in sleeve gastrectomy (0.8 % in G1, 18.1 % in G2, and 39.6 % in G3; p < 0.001). An overall mortality rate of 0.3 % was reported. CONCLUSIONS: Data from Spain is similar to data observed worldwide. Information recorded in the National Registries like RICIBA is necessary in order to safely expand bariatric surgery in response to increasing demand.


Assuntos
Cirurgia Bariátrica/estatística & dados numéricos , Obesidade Mórbida/cirurgia , Cirurgia Bariátrica/métodos , Cirurgia Bariátrica/tendências , Comorbidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/mortalidade , Período Pós-Operatório , Prevalência , Sistema de Registros , Espanha/epidemiologia
5.
Nutr. hosp ; 31(2): 642-648, feb. 2015. tab, graf
Artigo em Inglês | IBECS | ID: ibc-133450

RESUMO

Purpose: To determine the impact of Laparoscopic Sleeve Gastrectomy (LSG) on the resolution of type 2 diabetes (T2DM) and Prediabetes (PDM) in obese patients, as well as potential improvements in other comorbidities. Material and Methods: Observational retrospective study. We studied all patients with T2DM (n= 36) or PDM (n= 44) who underwent LSG in our hospital between years 2009 and 2012. PDM was defined as having at least 2 values of HbA1c between 5.7 and 6.4%. Follow-up period was 1-4 years (mean 17.5 months). T2DM remission criteria were fasting plasma glucose (FPG)<100 mg/ dl and HbA1c<6% without using hypoglycemic agents. PDM remission criteria were HbA1c< 5.7% plus FPG< 100 mg/dL. Results: Quantitative variables are defined as mean ± standard deviation. T2DM group: Description at baseline: 66% women, age 49.5±9.9 years, weight 132.2±18.8 Kg, Body Mass Index (BMI) 50.4±5.2 Kg/m2, HbA1c 7.8±1.9%. After LSG, weight was 94.2±20.5 Kg, BMI 35.8±6.4 and HbA1c 6.1±1.2 % (p<0.0001). T2DM improved in 97.6% patients, with a remission rate of 58.3% (n=21). Improvement or resolution of comorbidities was as follows: dyslipidemia 64%, Hypertension 39.3%, Obstructive Sleep Apnea 26.3%. PDM group: Baseline: 59% women, age 42.7 ± 8.2 years, weight: 144.2±26.2 Kg, BMI 50.6±5.5 Kg/m2. Post-LSG: weight 92.7±16.5 Kg, BMI 32.8±4.8 Kg/m2 (p<0.0001). HbA1c decreased from 6.04±0.3 % to 5.31±0.27 % (p<0.0001) after LSG. 95.5% of patients that initially met PDM criteria achieved FPG<100 mg/dl and HbA1c<5.7% (resolution of PDM). Conclusion: LSG effectively achieves improvement or remission of T2DM or PDM in obese patients meeting surgical treatment criteria (AU)


Objetivos: Evaluar la efectividad de la gastroplastia tubular laparoscópica (GTL) en la resolución de la diabetes tipo 2 (DM2), de la prediabetes (PDM) y de otras comorbilidades en pacientes obesos. Material y métodos: Estudio observacional retrospectivo. Se incluyeron a los pacientes con DM2 (n= 36) o PDM (n= 44) que fueron sometidos a GTL en nuestro hospital entre 2009 y 2012. Se consideró criterio de PDM presentar HbA1c entre 5.7-6.4% en al menos dos ocasiones. Periodo de seguimiento entre 1-4 años (media 17.5 meses). Como criterio de resolución de la DM2 se consideró presentar HbA1c<6% con glucemia basal (GB)<100 mg/ dL sin hipoglucemiantes. Se definió resolución de PDM como HbA1c<5.7% y GB<100 mg/dL. Resultados: Variables cuantitativas expresadas como media±DS. Grupo de pacientes con DM2: 66% mujeres, 49.5±9.9 años, 132.2±18.8 Kg, Índice de Masa Corporal (IMC) 50.4±5.2 Kg/m2, HbA1c 7.8±1.9%. Tras GTL el peso fue 94.2±20.5 Kg, el IMC 35.8±6.4 y la HbA1c 6.1±1.2% (p<0.0001). La DM2 mejoró en el 97.6% de los pacientes, con una tasa de resolución del 58.3%(n=21). La resolución o mejoría de las comorbilidades fue la siguente: dislipemia 64%, hipertensión 39.3%, SAOS 26.3%. Grupo de pacientes con PDM: 59% mujeres, 42.7±8.2 años, 144.2±26.2 Kg, IMC 50.6±5.5 Kg/m2. Tras GTL: Peso 92.7±16.5 Kg, IMC 32.8±4.8 Kg/m2 (p<0.0001). La HbA1c se redujo de 6.04±0.3% a 5.31±0.27% tras GTL( p<0.0001). El 95.5% de los pacientes con PDM obtuvo criterios de curación de la PDM (GB<100 mg/dl y HbA1c<5.7%). Conclusiones: La GTL es eficaz en la resolución de la DM2 y PDM en pacientes obesos con criterios de cirugía bariátrica (AU)


Assuntos
Humanos , Masculino , Feminino , Adulto , Cirurgia Bariátrica , Diabetes Mellitus Tipo 2/cirurgia , Estado Pré-Diabético/cirurgia , Laparoscopia , Glicemia , Estudos Retrospectivos , Estudo Observacional , Resultado do Tratamento
6.
Obes Surg ; 25(3): 436-42, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25125138

RESUMO

BACKGROUND: Bariatric surgery (BS) has become more frequent among women of child-bearing age. Data regarding the underlying maternal and perinatal risks are scarce. The objective of this nationwide study is to evaluate maternal and perinatal outcomes after BS. METHODS: We performed a retrospective observational study of 168 pregnancies in 112 women who underwent BS in 10 tertiary hospitals in Spain over a 15-year period. Maternal and perinatal outcomes, including gestational diabetes mellitus (GDM), pregnancy-associated hypertensive disorders (PAHD), pre-term birth cesarean deliveries, small and large for gestational age births (SGA, LGA), still births, and neonatal deaths, were evaluated. Results were further compared according to the type of BS performed: restrictive techniques (vertical-banded gastroplasty, sleeve gastrectomy, and gastric banding), Roux-en-Y gastric bypass (RYGB), and biliopancreatic diversion (BPD). RESULTS: GDM occurred in five (3 %) pregnancies and there were no cases of PAHD. Women whose pregnancies occurred before 1 year after BS had a higher pre-gestational body mass index (BMI) than those who got pregnant 1 year after BS (34.6 ± 7.7 vs 30.4 ± 5.3 kg/m(2), p = 0.007). In pregnancies occurring during the first year after BS, a higher rate of stillbirths was observed compared to pregnancies occurring after this period of time (35.5 vs 16.8 %, p = 0.03). Women who underwent BPD delivered a higher rate of SGA babies than women with RYGB or restrictive procedures (34.8, 12.7, and 8.3 %, respectively). CONCLUSIONS: Pregnancy should be scheduled at least 1 year after BS. Malabsorptive procedures are associated to a higher rate of SGA births.


Assuntos
Cirurgia Bariátrica , Obesidade Mórbida/cirurgia , Complicações na Gravidez/cirurgia , Adulto , Feminino , Humanos , Recém-Nascido , Gravidez , Resultado da Gravidez , Estudos Retrospectivos , Espanha
7.
Nutr. hosp ; 29(4): 873-879, abr. 2014. tab
Artigo em Espanhol | IBECS | ID: ibc-143819

RESUMO

La dieta de textura modificada supone una importante pérdida de las cualidades organolépticas de la alimentación, por lo que suele asociarse a una ingesta subóptima y puede aumentar el riego de desnutrición en personas con dificultades de masticación o deglución. Es conocido que estas dietas basadas en los tradicionales triturados, presentan una suficiencia nutricional variable. La aparición de numerosos productos comerciales deshidratados o listos para su consumo, con una amplia variedad nutricional, según sea la gama y receta de que se trate, suponen un importante avance en la normalización del valor nutricional y en la garantía de la alimentación de personas con disfagia. En esta revisión se comentan sus posibles ventajas o inconvenientes, frente a los tradicionales triturados, así como las posibilidades de su incorporación en el menú de hospitales y residencias (AU)


Texture modified diet is a significant loss of the organoleptic qualities of the feed, so often associated with suboptimal intake and can increase the risk of malnutrition in people with chewing or swallowing difficulties. It is known that these diets based on traditional ground, have varying nutritional adequacy. The emergence of numerous commercial products lyophilized or ready to eat, with a wide variety of nutritional value, according to the range and recipe is concerned, represent an important step in the normalization of nutritional value and food security in people with dysphagia. This review discussed the possible advantages or disadvantages compared to traditional ground, and the possibilities of inclusion in the menu of hospitals and nursing homes (AU)


Assuntos
Humanos , Alimentos Formulados , Nutrição do Idoso , Transtornos de Deglutição/dietoterapia , Alimentos Preparados , Alimentação Coletiva , Serviços de Alimentação/organização & administração
9.
Nutr Hosp ; 31(2): 642-8, 2014 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-25617545

RESUMO

PURPOSE: To determine the impact of Laparoscopic Sleeve Gastrectomy (LSG) on the resolution of type 2 diabetes (T2DM) and Prediabetes (PDM) in obese patients, as well as potential improvements in other comorbidities. MATERIAL AND METHODS: Observational retrospective study. We studied all patients with T2DM (n= 36) or PDM (n= 44) who underwent LSG in our hospital between years 2009 and 2012. PDM was defined as having at least 2 values of HbA1c between 5.7 and 6.4%. Follow-up period was 1-4 years (mean 17.5 months). T2DM remission criteria were fasting plasma glucose (FPG).


Assuntos
Cirurgia Bariátrica , Diabetes Mellitus Tipo 2/cirurgia , Laparoscopia , Estado Pré-Diabético/cirurgia , Adulto , Glicemia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
11.
Br J Nutr ; 97(5): 823-31, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17408522

RESUMO

Use of n-3 fatty acids (FA) has been reported to be beneficial for cancer patients. We performed a systematic review of the literature in order to issue recommendations on the clinical use of n-3 FA in the cancer setting. A systematic search was performed in MEDLINE, EMBASE, Cochrane and Healthstar databases. We selected clinical trials or prospective observational studies including patients with cancer and life expectancy >2 months, in which enteral supplements with n-3 FA were administered. Parameters evaluated individually were clinical (nutritional status, tolerance, survival and hospital stays), biochemical (inflammatory mediators), and functional (functional status, appetite and quality of life (QoL)). Seventeen studies met the inclusion criteria; eight were of high quality. The panel of experts established the following evidence: (1) oral supplements with n-3 FA benefit patients with advanced cancer and weight loss, and are indicated in tumours of the upper digestive tract and pancreas; (2) the advantages observed were: increased weight and appetite, improved QoL, and reduced post-surgical morbidity; (3) there is no defined pattern for combining different n-3 FA, and it is recommended to administer > 1.5 g/day; and (4) better tolerance is obtained administering low-fat formulas for a period of at least 8 weeks. All the evidences were grade B but for 'length of treatment' and 'advantage of survival' it was grade C. Our findings suggest that administration of n-3 FA (EPA and DHA) in doses of at least 1.5 g/day for a prolonged period of time to patients with advanced cancer is associated with an improvement in clinical, biological and QoL parameters.


Assuntos
Suplementos Nutricionais , Neoplasias do Sistema Digestório/prevenção & controle , Ácidos Graxos Ômega-3/administração & dosagem , Caquexia/prevenção & controle , Neoplasias do Sistema Digestório/mortalidade , Ácido Eicosapentaenoico/administração & dosagem , Ácido Eicosapentaenoico/efeitos adversos , Ácidos Graxos Ômega-3/efeitos adversos , Humanos , Guias de Prática Clínica como Assunto , Fatores de Tempo , Resultado do Tratamento
12.
JPEN J Parenter Enteral Nutr ; 29(1): 21-9, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-15715270

RESUMO

BACKGROUND: Type 2 diabetic patients may need enteral nutrition support as part of their treatment. The objective was to compare glycemic and lipid control in hospitalized patients with type 2 diabetes requiring feeding via nasogastric tube using enteral feedings with either a highcarbohydrate or a high-monounsaturated-fat content. METHODS: This trial included type 2 diabetes patients admitted to the hospital for neurologic disorders or head and neck cancer surgery who received either a low-carbohydrate-high-mono-unsaturated-fat (Glucerna) or a high-carbohydrate diet (Precitene Diabet). Glycemic and lipid control was determined weekly. Safety and gastrointestinal tolerance were also assessed. RESULTS: A total of 104 patients were randomized and 63 were evaluable according to preestablished protocol criteria. Median duration of therapy was 13 days in both groups. Mean glucose was significantly increased at 7 days of treatment (p = .006) in the Precitene arm, with no significant variations in the Glucerna arm. Mean weekly blood triglycerides levels in the Precitene arm were increased without reaching statistical significance, whereas patients in the Glucerna arm showed a stable trend. Patients in the Precitene arm showed a significantly higher incidence of diarrhea than patients in Glucerna arm (p = .008), whereas the incidence of nausea was smaller in the Precitene arm than in the Glucerna arm (p = .03). CONCLUSIONS: An enteral formula with lower carbohydrate and higher monounsaturated fat (Glucerna) has a neutral effect on glycemic control and lipid metabolism in type 2 diabetic patients compared with a high-carbohydrate and a lower-fat formula (Precitene Diabet).


Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 2/terapia , Carboidratos da Dieta/metabolismo , Gorduras Insaturadas na Dieta/metabolismo , Nutrição Enteral/métodos , Metabolismo dos Lipídeos , Idoso , Diabetes Mellitus Tipo 2/metabolismo , Diarreia/etiologia , Diarreia/metabolismo , Feminino , Hospitalização , Humanos , Masculino , Náusea/etiologia , Náusea/metabolismo
13.
World J Surg ; 26(1): 2-8, 2002 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-11898025

RESUMO

Patients suffering severe burns have an accelerated catabolism with a highly negative nitrogen balance that may worsen their prognosis. Somatropin treatment has been shown to improve this balance in different hypercatabolic situations. Moreover, in children with extensive burns it also reduces the healing time of the skin graft donor site and shortens the hospital stay. In the existing literature there are no controlled prospective clinical trials in adult patients that confirm these data. Our aim was to demonstrate the efficacy of recombinant growth hormone (somatropin) in reducing the healing time of the skin graft donor sites and the length of stay in the burn unit in adult patients with severe burns. A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 adult patients with severe burns (more than 40% of the total body surface burned or more than 15% full-thickness burns). Patients received placebo (n = 11) or somatropin (n = 13) at a dosage of 0.15 mg/kg/day divided into two equal doses (every 12 hours) via intramuscular injection. Treatment was initiated the day the first autograft was performed and terminated the day the patient was discharged from the burn unit. The mean number (+/- SD) of skin grafts per patient was similar between the two groups (4.2 +/- 1.8 vs 3.4 +/- 1.8 in the placebo and somatropin groups, respectively). No reduction in the healing time of the skin graft donor site was observed in the somatropin group compared to the placebo group. Likewise, the time admitted to the burn unit was not significantly different, either in the absolute number of days (36.2 +/- 19.7 vs 30.1 +/- 16.8 days in the placebo and somatropin groups, respectively) or in relation to the percentage of the total body surface burned or the body surface with full-thickness burns. Growth hormone and insulin-like growth factor I (IGF-I) levels were three and five times higher, respectively, in the somatropin group than in the placebo group. Ten of the patients treated with somatropin experienced hyperglycemia, and seven of them required insulin treatment. No other adverse side effect was observed. One patient in the placebo group died as a result of sepsis and multiple organ failure. Somatropin, with the treatment regimen and dosage used in these studies, did not reduce the healing time of the skin graft donor sites or the length of hospitalization in the burn unit in adult patients with severe burns.


Assuntos
Queimaduras/tratamento farmacológico , Queimaduras/cirurgia , Proteína Receptora de AMP Cíclico/efeitos dos fármacos , Hormônio do Crescimento Humano/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Transplante de Pele , Cicatrização/efeitos dos fármacos , Adulto , Unidades de Queimados , Queimaduras/fisiopatologia , Método Duplo-Cego , Feminino , Hormônio do Crescimento Humano/administração & dosagem , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Proteínas Recombinantes/administração & dosagem , Fatores de Tempo , Índices de Gravidade do Trauma , Cicatrização/fisiologia
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