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锌或维生素A补充剂用于急性腹泻幼儿的双盲、随机、对照试验。

Double-blind, randomized, controlled trial of zinc or vitamin A supplementation in young children with acute diarrhoea.

作者信息

Faruque A S, Mahalanabis D, Haque S S, Fuchs G J, Habte D

机构信息

International Centre for Diarrhoeal Disease Research, Bangladesh, India.

出版信息

Acta Paediatr. 1999 Feb;88(2):154-60. doi: 10.1080/08035259950170312.

DOI:10.1080/08035259950170312
PMID:10102147
Abstract

In a double-blind, controlled trial with a factorial design, 684 patients (aged 6 months to 2 y; excludes 6 early dropouts) with acute watery diarrhoea of 3 d or less and some dehydration, who were attending a hospital, were randomly assigned to 4 groups to receive: (a) vitamin A 4500 microg retinol equivalent daily for 15 d; (b) 14.2 mg elemental zinc as acetate for the first 417 patients and 40 mg of the remaining 273 patients randomized to this group for 15 d; (c) both vitamin A 4500 microg retinol equivalent and zinc at the above doses daily for 15 d; or (d) placebo mixtures for 15 d. Patients were observed in the hospital for 24 h and followed up at home for 15 d. All received ascorbic acid 30 mg with each dose of medicine or placebo. Zinc supplementation was associated with a reduced duration of diarrhoea (13%, p = 0.03) and markedly reduced rate (43%, p = 0.017) of prolonged diarrhoea (>7 d). Vitamin A supplementation was associated with a nonsignificant trend for reduced rate of prolonged diarrhoea (p = 0.089). In conclusion, zinc supplementation as adjunct therapy had a substantial impact on the rate of prolonged diarrhoea and some impact on duration and may be beneficial in children with diarrhoea in developing countries.

摘要

在一项采用析因设计的双盲对照试验中,684名(年龄6个月至2岁;不包括6名早期退出者)患有3天及以内急性水样腹泻且有一定程度脱水的住院患儿,被随机分为4组,分别接受:(a) 每天4500微克视黄醇当量的维生素A,共15天;(b) 对于前417名患者,给予14.2毫克元素锌(以醋酸锌形式),对于随机分到该组的其余273名患者给予40毫克元素锌,共15天;(c) 每天给予4500微克视黄醇当量的维生素A和上述剂量的锌,共15天;或(d) 给予15天的安慰剂混合物。患儿在医院观察24小时,并在家中随访15天。每次给予药物或安慰剂时均同时给予30毫克抗坏血酸。补充锌与腹泻持续时间缩短(13%,p = 0.03)以及迁延性腹泻(>7天)发生率显著降低(43%,p = 0.017)相关。补充维生素A与迁延性腹泻发生率降低的趋势不显著(p = 0.089)。总之,补充锌作为辅助治疗对迁延性腹泻发生率有显著影响,对腹泻持续时间也有一定影响,可能对发展中国家腹泻患儿有益。

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