含不可消化碳水化合物混合物的口服补液溶液治疗急性腹泻：代表欧洲儿科胃肠病、肝病和营养学会肠道感染工作组进行的一项多中心随机安慰剂对照研究

Oral rehydration solution containing a mixture of non-digestible carbohydrates in the treatment of acute diarrhea: a multicenter randomized placebo controlled study on behalf of the ESPGHAN working group on intestinal infections.

作者信息

Hoekstra J H, Szajewska H, Zikri M Abu, Micetic-Turk D, Weizman Z, Papadopoulou A, Guarino A, Dias J A, Oostvogels B

机构信息

Department of Paediatrics, Hieronymus Bosch Hospital, 's-Hertogenbosch, The Netherlands.

出版信息

J Pediatr Gastroenterol Nutr. 2004 Sep;39(3):239-45. doi: 10.1097/00005176-200409000-00003.

DOI:10.1097/00005176-200409000-00003

PMID:15319622

Abstract

OBJECTIVE

A randomized, double-blind, placebo-controlled multicenter study to evaluate efficacy and safety of a mixture of non-digestible carbohydrates (NDC) as an adjunct to oral rehydration therapy in treatment of acute infectious diarrhea in children with mild to moderate dehydration.

METHODS

144 boys aged 1 to 36 months with diarrhea defined as three or more watery stools per day for >1 day but <5 days with mild or moderate dehydration (World Health Organization criteria) were randomly assigned to receive hypotonic oral rehydration solution (ORS) (Na 60 mmol/L, glucose 111 mmol/L) with or without a mixture of NDC (soy polysaccharide 25%, alpha-cellulose 9%, gum arabic 19%, fructooligosaccharides 18.5%, inulin 21.5%, resistant starch 7%).

RESULTS

Intention-to-treat analysis did not show significant differences in mean 48 hour stool volume (ESPGHAN-ORS with NDC versus ESPGHAN-ORS, 140 +/- 124 g/kg versus 143 +/- 114 g/kg; P = 0.41). Duration of diarrhea after randomization was similar in both groups (82 +/- 39 hours versus 97 +/- 76 hours, P = 0.24). There were no significant differences in the duration of hospital stay (111 +/- 44 hours versus 126 +/- 78 hours; P = 0.3). Unscheduled intravenous rehydration was similar in both groups (21.4% versus 16.2%, P = 0.42).

CONCLUSION

In boys with acute non-cholera diarrhea with mild to moderate dehydration a mixture of non-digestible carbohydrates was ineffective as an adjunct to oral rehydration therapy.

摘要

目的

一项随机、双盲、安慰剂对照的多中心研究，以评估不可消化碳水化合物（NDC）混合物作为口服补液疗法辅助手段治疗轻度至中度脱水儿童急性感染性腹泻的疗效和安全性。

方法

144名年龄在1至36个月的男孩，腹泻定义为每日三次或更多次水样便，持续超过1天但少于5天，伴有轻度或中度脱水（世界卫生组织标准），被随机分配接受低渗口服补液溶液（ORS）（钠60 mmol/L，葡萄糖111 mmol/L），其中一组添加NDC混合物（大豆多糖25%、α-纤维素9%、阿拉伯胶19%、低聚果糖18.5%、菊粉21.5%、抗性淀粉7%）。

结果

意向性分析显示，48小时平均粪便量无显著差异（添加NDC的欧洲儿科胃肠病、肝病和营养学会口服补液盐与欧洲儿科胃肠病、肝病和营养学会口服补液盐相比，分别为140±124 g/kg和143±114 g/kg；P = 0.41）。随机分组后两组腹泻持续时间相似（82±39小时与97±76小时，P = 0.24）。住院时间无显著差异（111±44小时与126±78小时；P = 0.3）。两组非计划静脉补液情况相似（21.4%对16.2%，P = 0.42）。