Larson Charles Palmer, Hoque A B M Mominul, Larson Charles Philip, Khan Ali Miraj, Saha Unnati Rani
Health Systems and Infectious Diseases Division ICDDR,B: Centre for Health and Population Research GPO Box 128, Dhaka 1000 Bangladesh.
J Health Popul Nutr. 2005 Dec;23(4):311-9.
The childhood diarrhoea-management guidelines of the World Health Organization/United Nations Children's Fund (WHO/UNICEF) now include zinc treatment, 20 mg per day for 10 days. To determine if a dispersible zinc sulphate tablet formulation is associated with increased risk of vomiting or regurgitation following the initial, first treatment dose, a double-blind, placebo-controlled randomized clinical trial was carried out in the Dhaka hospital of ICDDR,B: Centre for Health and Population Research (n=800) and in an adjacent NGO outpatient clinic (n=800). Children were randomized to one of three groups: no treatment, placebo, or zinc sulphate tablet (20 mg). They were then observed for 60 minutes, and all vomiting or regurgitation episodes were recorded. When compared with placebo, zinc treatment resulted in an attributable risk increase of 14% for vomiting and 5.2% for regurgitation. The median time to vomiting among those receiving zinc was 9.6 minutes and was limited to one episode in 91.2% of the cases. Overall, the proportion of 60-minute post-treatment vomiting attributable to zinc, placebo, and the illness episode was estimated to be 40%, 26%, and 34% respectively. The dispersible zinc sulphate tablet formulation at a dose of 20 mg is associated with increased risks of vomiting and regurgitation. Both are transient side-effects.
世界卫生组织/联合国儿童基金会（WHO/UNICEF）的儿童腹泻管理指南现纳入了锌治疗，即每日20毫克，持续10天。为确定可分散片剂硫酸锌制剂在首次治疗剂量后是否会增加呕吐或反流风险，在达卡的国际腹泻疾病研究中心孟加拉国分中心（ICDDR,B）健康与人口研究中心（n = 800）及相邻的一个非政府组织门诊诊所（n = 800）开展了一项双盲、安慰剂对照随机临床试验。儿童被随机分为三组之一：不治疗、安慰剂或硫酸锌片（20毫克）。然后对他们进行60分钟观察，并记录所有呕吐或反流发作情况。与安慰剂相比，锌治疗导致呕吐的归因风险增加14%，反流的归因风险增加5.2%。接受锌治疗者呕吐的中位时间为9.6分钟，91.2%的病例仅限于一次发作。总体而言，治疗后60分钟内归因于锌、安慰剂和疾病发作的呕吐比例估计分别为40%、26%和34%。20毫克剂量的可分散片剂硫酸锌制剂与呕吐和反流风险增加相关。两者均为短暂的副作用。
