南非HIV-1感染患儿接受补锌疗法的安全性与疗效研究:随机双盲、安慰剂对照试验

作     者：Bobat R. Coovadia H. Stephen C. W.J. Moss 张振 

作者机构：Department of Epidemiology Bloomberg School of Public Health Johns Hopkins University Baltimore MD 21205 United States.Dr 

出 版 物：《世界核心医学期刊文摘（儿科学分册）》 (Dkgest of the World Latest Medical Information)

年 卷 期：2006年第2卷第4期

页      面：2-3页

学科分类：1002[医学-临床医学] 100202[医学-儿科学] 10[医学] 

主　　题：补锌 HIV-1感染 随机双盲 疗效研究 安慰剂对照 水样腹泻 锌缺乏 细胞百分数 病毒载量 病毒复 

摘      要：Background: Zinc deficiency is associated with impaired immune function and an increased risk of infection. Supplementation can decrease the incidence of diarrhoea and pneumonia in children in resource-poor countries. However, in children with HIV- 1 infection, the safety of zinc supplementation is uncertain. We aimed to assess the role of zinc in HIV- 1 replication before mass zinc supplementation is recommended in regions of high HIV- 1 prevalence. Methods: We did a randomised double-blind placebo-controlled equivalence trial of zinc supplementation at Grey’s Hospital in Pietermaritzburg, South Africa. 96 children with HIV- 1 infection were randomly assigned to receive 10 mg of elemental zinc as sulphate or placebo daily for 6 months. Baseline measurements of plasma HIV- 1 viral load and the percentage of CD4+ T lymphocytes were established at two study visits before randomisation, and measurements were repeated 3, 6, and 9 months after the start of supplementation. The primary outcome measure was plasma HIV- 1 viral load. Analysis was per protocol. Findings: The mean log10 HIV- 1 viral load was 5.4 (SD 0.61) for the placebo group and 5.4 (SD 0.66) for the zinc-supplemented group 6 months after supplementation began (difference 0.0002, 95% CI - 0.27 to 0.27). 3 months after supplementation ended, the corresponding values were 5.5 (SD 0.77) and 5.4 (SD 0.61), a difference of 0.05 (- 0.24 to 0.35). The mean percentage of CD4+ T lymphocytes and median haemoglobin concentrations were also similar between the two groups after zinc supplementation. Two deaths occurred in the zinc supplementation group and seven in the placebo group (p=0.1). Children given zinc supplementation were less likely to get watery diarrhoea than those given placebo. Watery diarrhoea was diagnosed at 30 (7.4% ) of 407 clinic visits in the zinc-supplemented group versus 65 (14.5% ) of 447 visits in the placebo group (p=0.001). Interpretation. Zinc supplementation of HIV- 1- infected children does