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两种口服溶液作为急性腹泻维持治疗的疗效和安全性。一项双盲、随机、多中心试验。

Efficacy and safety of two oral solutions as maintenance therapy for acute diarrhea. A double-blind, randomized, multicenter trial.

作者信息

Leung A K, Taylor P G, Geoffroy L, Darling P

机构信息

Department of Pediatrics, Alberta Children's Hospital, Calgary, Canada.

出版信息

Clin Pediatr (Phila). 1988 Aug;27(8):359-64. doi: 10.1177/000992288802700801.

DOI:10.1177/000992288802700801
PMID:3079536
Abstract

There is continuing uncertainty about the appropriate level of sodium in oral fluid therapy for children with acute gastroenteritis in developed countries. The present study was undertaken in order to assess whether an oral glucose/electrolyte solution designed for fluid replacement (Na+ concentration 75 mmol/l) and an oral glucose/electrolyte solution designed for maintenance of hydration (Na+ concentration 45 mmol/l) would be safe and effective in the treatment of acute childhood diarrhea in a developed country. Children aged 3-24 months (n = 54) with acute diarrhea and less than 5 percent dehydration were randomized to receive either maintenance (n = 27) or rehydration (n = 27) fluid. Outcome was assessed at 24 and 48 hours after entry to the study. Both solutions were found to be equally effective and safe. The fluid was refused by one child in each group. Analysis of efficacy showed that hydration status was maintained in all patients and 98 percent of children showed significant improvement in diarrheal status at 24 hours. We conclude that for well-nourished ambulatory children aged 3-24 months with acute diarrhea and minimal (less than 5%) or no dehydration, the use of an oral fluid containing 75 mmol/l of sodium is as safe and effective as the use of an oral fluid containing 45 mmol/l of sodium.

摘要

在发达国家,对于急性肠胃炎患儿口服补液疗法中钠的合适含量一直存在不确定性。开展本研究是为了评估一种用于补液的口服葡萄糖/电解质溶液(钠浓度75 mmol/L)和一种用于维持水合作用的口服葡萄糖/电解质溶液(钠浓度45 mmol/L)在发达国家治疗儿童急性腹泻时是否安全有效。3至24个月大的急性腹泻且脱水程度低于5%的儿童(n = 54)被随机分组,分别接受维持液(n = 27)或补液(n = 27)治疗。在进入研究后的24小时和48小时评估结果。发现两种溶液同样有效且安全。每组均有一名儿童拒绝接受补液。疗效分析显示,所有患者的水合状态均得以维持,98%的儿童在24小时时腹泻状况有显著改善。我们得出结论,对于3至24个月大、营养良好、患有急性腹泻且脱水程度轻微(低于5%)或无脱水的非卧床儿童,使用含75 mmol/L钠的口服补液与使用含45 mmol/L钠的口服补液一样安全有效。

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