锌补充剂预防 HIV 感染成人免疫失败的随机对照临床试验。
Randomized, controlled clinical trial of zinc supplementation to prevent immunological failure in HIV-infected adults.
机构信息
Florida International University, R. Stempel College of Public Health and Social Work, Miami, Florida, USA.
出版信息
Clin Infect Dis. 2010 Jun 15;50(12):1653-60. doi: 10.1086/652864.
BACKGROUND
Adequate zinc is critical for immune function; however, zinc deficiency occurs in >50% of human immunodeficiency virus (HIV)-infected adults. We examined the safety and efficacy of long-term zinc supplementation in relation to HIV disease progression.
METHODS
A prospective, randomized, controlled clinical trial was conducted involving 231 HIV-infected adults with low plasma zinc levels (<0.75 mg/L), who were randomly assigned to receive zinc (12 mg of elemental zinc for women and 15 mg for men) or placebo for 18 months. The primary end point was immunological failure. HIV viral load and CD4(+) cell count were determined every 6 months. Questionnaires, pill counts, and plasma zinc and C-reactive protein levels were used to monitor adherence to study supplements and antiretroviral therapy. Intent-to-treat analysis used multiple-event analysis, treating CD4(+) cell count <200 cells/mm(3) as a recurrent immunological failure event. Cox proportional hazard models and the general-linear model were used to analyze morbidity and mortality data.
RESULTS
Zinc supplementation for 18 months reduced 4-fold the likelihood of immunological failure, controlling for age, sex, food insecurity, baseline CD4(+) cell count, viral load, and antiretroviral therapy (relative rate, 0.24; 95% confidence interval, 0.10-0.56; P<.002). Viral load indicated poor control with antiretroviral therapy but was not affected by zinc supplementation. Zinc supplementation also reduced the rate of diarrhea by more than half (odds ratio, 0.4; 95% confidence interval, 0.183-0.981; P=.019), compared with placebo. There was no significant difference in mortality between the 2 groups.
CONCLUSIONS
This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of zinc supplementation as an adjunct therapy for HIV-infected adult cohorts with poor viral control. Trial registration. ClinicalTrials.gov identifier: NCT00149552.
背景
足够的锌对免疫功能至关重要；然而，锌缺乏症在超过 50%的人类免疫缺陷病毒（HIV）感染者中发生。我们研究了长期锌补充与 HIV 疾病进展的关系。
方法
进行了一项前瞻性、随机、对照临床试验，涉及 231 名 HIV 感染且血浆锌水平低（<0.75mg/L）的成年人，他们被随机分配接受锌（女性 12mg 元素锌，男性 15mg 元素锌）或安慰剂治疗 18 个月。主要终点是免疫失败。每 6 个月检测一次 HIV 病毒载量和 CD4+细胞计数。问卷、药丸计数以及血浆锌和 C 反应蛋白水平用于监测对研究补充剂和抗逆转录病毒治疗的依从性。意向治疗分析采用多事件分析，将 CD4+细胞计数<200 个细胞/mm3 作为复发性免疫失败事件。Cox 比例风险模型和一般线性模型用于分析发病率和死亡率数据。
结果
锌补充治疗 18 个月，将免疫失败的可能性降低了 4 倍，控制了年龄、性别、食物不安全、基线 CD4+细胞计数、病毒载量和抗逆转录病毒治疗（相对风险率，0.24；95%置信区间，0.10-0.56；P<.002）。病毒载量表明抗逆转录病毒治疗控制不佳，但不受锌补充的影响。锌补充还将腹泻率降低了一半以上（比值比，0.4；95%置信区间，0.183-0.981；P=.019），与安慰剂相比。两组之间的死亡率没有显著差异。
结论
这项研究表明，营养水平的长期（18 个月）锌补充延迟了免疫失败，并随着时间的推移减少了腹泻。这一证据支持将锌补充作为对病毒控制不佳的 HIV 感染成年患者群体的辅助治疗。试验注册。ClinicalTrials.gov 标识符：NCT00149552。
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