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一种生物活性多酚膳食补充剂在小儿急性腹泻患者中的安全性

Safety of a Bioactive Polyphenol Dietary Supplement in Pediatric Subjects with Acute Diarrhoea.

作者信息

Sarker Shafiqul A, Sultana Shamima, Pietroni Mark, Dover Arthur

机构信息

Dhaka Hospital, icddr,b, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh.

Dhaka Hospital, icddr,b, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka 1212, Bangladesh ; Department of Public Health, South Gloucestershire Council, Gloucestershire, UK.

出版信息

Int J Pediatr. 2015;2015:387159. doi: 10.1155/2015/387159. Epub 2015 Sep 7.

DOI:10.1155/2015/387159
PMID:26435718
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4576009/
Abstract

The hematological and clinical chemistry profile for children aged 6 months to 5 years with acute diarrhoea was measured in a double blind clinical trial. Subjects were randomized to the study group (N = 44) given a bioactive polyphenol dietary supplement in oral rehydration solution (ORS) or to the control group (N = 41) given distilled water as a placebo in ORS twice daily for up to 4 days. All subjects received 10 mg zinc daily for the 4 days in the study. Venous blood was collected for complete blood count, electrolytes, liver function, and creatinine upon enrollment (baseline) and at the end of 4 days (end of study); mean values were compared by 95% confidence intervals. Overall, blood factors measured either remained the same over the 4 days or increased or decreased at the same levels between the two groups during the study period. All values were within accepted ranges for paediatric subjects except serum AST (SGOT), where the mean value of the study group approached the upper bound of the range on day 4 but was comparable to the value of the control group. Consumption of this supplement twice daily for 4 days is safe for children and infants.

摘要

在一项双盲临床试验中,对6个月至5岁急性腹泻儿童的血液学和临床化学指标进行了测量。受试者被随机分为研究组(N = 44),在口服补液盐(ORS)中给予生物活性多酚膳食补充剂,或对照组(N = 41),在ORS中给予蒸馏水作为安慰剂,每天两次,持续4天。在研究的4天中,所有受试者每天接受10毫克锌。在入组时(基线)和4天结束时(研究结束)采集静脉血进行全血细胞计数、电解质、肝功能和肌酐检测;通过95%置信区间比较平均值。总体而言,在研究期间,所测量的血液指标在4天内要么保持不变,要么两组之间以相同水平升高或降低。除血清AST(SGOT)外,所有值均在儿科受试者的可接受范围内,研究组第4天的平均值接近该范围的上限,但与对照组的值相当。每天两次服用这种补充剂,持续4天,对儿童和婴儿是安全的。

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