ABSTRACT
BACKGROUND: End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin's efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. OBJECTIVE: The overall objective of this protocol is to (1) evaluate aspirin's safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin's efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. METHODS: We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. RESULTS: The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov. CONCLUSIONS: We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10516.
ABSTRACT
Introducción: estudios preclínicos del extracto total de la raíz de Jatropha curcas L. (piñón blanco) demostraron su efecto antidiarreico, en contraste, ensayos de toxicidad crónica del extracto total de la semilla muestran efecto diarreico. Objetivo: determinar el efecto sobre la motilidad intestinal del extracto de alcaloides de semilla de Jatropha curcas L. Métodos: se utilizaron 50 ratones albinos con pesos medios de 25 g, se empleó el método de Arbós y otros; se administró carbón activado al 5 % vía oral, dosis de 0,1 mL/10 g, como marcador intestinal. Los grupos experimentales fueron: agua destilada 0,1 mL/10 g, atropina 1 mg/kg, extracto de alcaloides de semilla de Jatropha curcas 500 y 1 000 mg/kg, respectivamente, y neostigmina 1 g/kg. Para la validación estadística se usó la prueba de Kruskal-Wallis, ANOVA, Tukey, y Newman-Keuls. Resultados: el porcentaje de recorrido del carbón activado fue de 69,21; 36,37; 58,96; 49,65 y 74,17, respectivamente. La prueba de ANOVA demostró diferencias estadísticas (p< 0,05; IC 95 %), y la prueba de Tukey y Newman-Keuls, demostraron diferencias significativas entre el grupo que recibió agua destilada y la planta a 1 000 mg/kg. Conclusiones: se comprobó efecto de disminución de la motilidad intestinal por acción del extracto de alcaloides de Jatropha curcas, en dosis de 1 000 mg/kg.
Introduction: preclinical research studies of Jatropha curcas L. (piñón blanco) root extract proved its antidiarrheal activity; however the chronic toxicity test of the total seed extract demonstrated diarrheal effect. Objectives: to determine the effect of the alkaloid extract from Jatropha curcas L. seeds on the gastrointestinal motility. Methods: fifty albino mice with average weight of 25 g were used. The Arbos et al.´s method was applied. The intestinal marker was 5 % activated charcoal administered at a dose of 0.1 mL/10 g. The experimental groups included 0.1 mL/10 g of distilled water, 1.5 mg/kg of atropine, alkaloid extract of Jatropha curcas L. seeds at doses of 500 and 1 000 mg/kg respectively, and 1 g/kg of neostigmine The statistical validation was based on Kruskal-Wallis test, ANOVA, and Tukey and Newman-Keuls test. Results: the percentages of the charcoal run were 69.21, 36.37, 58.96, 49.65, and 74.17 respectively. The ANOVA test demonstrated statistical significance (p< 0.05, IC 95 %). Comparative Tukey and Newman-Keuls test showed statistical significance between distilled water and Jatropha curcas at a dose of 1 000 mg/kg. Conclusions: the decrease on the gastrointestinal motility resulting from the effect of the alkaloid extract of Jatropha curcas seeds was proved at a dose of 1 000 mg/kg.
ABSTRACT
OBJETIVO: Describir el estado nutricional de niños de 6 a 10 años, de la Comunidad de Niños ôSagrada Familiaõ de Lima-Perú, durante marzo 2011. MATERIAL Y MÉTODO: Estudio descriptivo, transversal y prospectivo. Se estudió a 126 niños y niñas entre 6 y 10 años. Se consideró como variables: peso, talla e IMC. Para los diagnósticos de malnutrición se utilizaron: índices de Peso/edad, Talla/edad e IMC/edad, según el criterio actual de la OMS. Se determinó el valor ôzõ mediante programa OMS-AnthroPlus v1.0.4. El análisis de datos se realizó con el programa SPSS v15.0. RESULTADOS: 73% hombres y 27% mujeres, la mayoría tenían 10 años (29,4%). La media de peso, talla e IMC fueron 25,23 kg; 122,14 cm y 16,82 kg/m2. En cuanto al diagnóstico nutricional; 5,6% de niños presentaron desnutrición global, 23,8% desnutrición crónica, 21,4% sobrepeso y 2,4% obesidad, los hombres presentaron mayor porcentaje de desnutrición global (7,7%), desnutrición crónica (27,5%) y sobrepeso (23,1%), en cambio las mujeres presentaron mayor porcentaje de obesidad (2,9%). 71,4% de niños con desnutrición global eran desnutridos crónicos, 22,2% con sobrepeso poseían desnutrición crónica y 100% de obesos tenían crecimiento normal. CONCLUSIONES: El diagnóstico de malnutrición con mayor prevalencia es la desnutrición crónica. Además, se encontró solo casos de desnutridos crónicos con sobrepeso. Por tanto, a pesar que la desnutrición crónica está disminuyendo, no evita que sea la de mayor prevalencia a nivel escolar.
OBJETIVE: To describe the nutritional status of children from 6 to 10 years of age in the ôSagrada Familiaõ child community in Lima, Perú, in March 2011. MATERIALS AND METHOD: Type of study is descriptive, transversal and prospective. We studied 126 children between 6 and 10 years of the ôSagrada Familiaõchild community. The variables considered were weight, height and BMI as well as the diagnosis of malnutrition rates using weight / age, height / age and BMI / age current WHO criteria. We determined the value ôzõ using WHO-AnthroPlus v1.0.4. Data analysis was performed using SPSS v15.0. RESULTS: 73% were male and 27% female, most were 10 years of age (29.4%). Mean weight, height and BMI were 25.23 kg, 122.14 cm and 16.82 kg/m2 respectively. As for the nutritional diagnosis, 5.6% of children had global malnutrition, 23.8% had chronic malnutrition, 21.4% were overweight and 2.4% obese, males had a higher percentage of global malnutrition (7.7%), chronic malnutrition (27.5%) and overweight (23.1%), whereas women had a higher percentage of obesity (2.9%). 71.4% of children with global malnutrition had chronic malnutrition, 22.2% who were overweight had chronic malnutrition, and 100 % of obese have normal growth. CONCLUSIONS: The diagnosis of malnutrition is most prevalent as chronic malnutrition. It was also found only cases of chronically undernourished with overweight. Therefore, although chronic malnutrition is declining, it doesn´t stop being the most prevalent at school level.
