Randomized, controlled clinical trial of zinc supplementation to prevent immunological failure in HIV-infected adults.

Randomized, controlled clinical trial of zinc supplementation to prevent immunological failure in HIV-infected adults.
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DOI:
10.1086/652864
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发表时间:
2010-06-15
期刊:
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子:
--
通讯作者:
Campa A
Campa A
中科院分区:
其他
文献类型:
--
作者:
Baum MK;Lai S;Sales S;Page JB;Campa A

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充足的锌对免疫功能至关重要;然而,锌缺乏症发生在50%的艾滋病毒感染的成年人。我们研究了长期补充锌对HIV疾病进展的安全性和有效性。一项前瞻性随机对照临床试验对231名血浆锌水平低(<0.75 μg/ml)的HIV阳性成年人进行了为期18个月的随机对照试验,随机分配到锌组(女性12 mg元素锌,男性15 mg)或安慰剂组。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。问卷调查、药片计数、血浆锌和c反应蛋白(hsCRP)用于监测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细胞/mm3视为复发性免疫失败事件。采用Cox比例风险模型和一般线性模型分析发病率和死亡率数据。在控制年龄、性别、缺乏食物、基线CD4+细胞计数、病毒载量和抗逆转录病毒治疗的情况下,补锌18个月使免疫功能衰竭的可能性降低了4倍(RR=0.24[95%CI:0.10,0.56],p<0.002)。病毒载量表明抗逆转录病毒治疗控制不佳,但补充锌没有影响。与安慰剂相比,补充锌也使腹泻率降低了一半以上(OR=0.4[95%CI:0.183-0.981],p=0.019)。两组患者的死亡率无显著差异。该研究表明,在营养水平上长期(18个月)补充锌可以延缓免疫功能衰竭,减少腹泻。这一证据支持在病毒控制不佳的HIV+成人队列中使用锌补充剂作为辅助治疗。该研究表明,在营养水平上长期(18个月)补充锌可以延缓免疫功能衰竭,减少腹泻。这一证据支持在病毒控制不佳的HIV+成人队列中使用锌补充剂作为辅助治疗。
Adequate zinc is critical for immune function; however, zinc deficiency occurs in >50% of HIV-infected adults. We examined the safety and efficacy of long-term zinc supplementation on HIV disease progression. A prospective randomized controlled clinical trial was conducted with 231 HIV+ adults with low plasma zinc levels (<0.75 μg/ml), randomly assigned into zinc (12 mg of elemental zinc for women and 15 mg for men) or placebo, for 18 months. The primary endpoint was immunological failure. HIV-viral load and CD4+ cell count were determined every 6 months. Questionnaires, pill-counts, plasma zinc and C-reactive protein (hsCRP) were used to monitor adherence with study supplements and ART. Intent-to-treat analysis utilized multiple-event analysis, treating CD4+ cell count <200 cells/mm3 as recurrent immunological failure event. Cox proportional-hazard models and the general-linear model were used to analyze morbidity and mortality data. Zinc supplementation for 18 months reduced four-fold the likelihood of immunological failure, controlling for age, gender, lack of food, baseline CD4+ cell count, viral load, and antiretroviral therapy (RR=0.24[95%CI:0.10,0.56],p<0.002). Viral load indicated poor control with ART but was not affected by zinc supplementation. Zinc supplementation also reduced the rate of diarrhea by more than half (OR=0.4[95%CI:0.183-0.981],p=0.019) compared to placebo. There was no significant difference in mortality between the two groups. 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 in HIV+ adult cohorts with poor viral control. 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 in HIV+ adult cohorts with poor viral control.
DOI: 10.1097/qai.0b013e31817bebb3
发表时间: 2008-08-15
期刊: Journal of acquired immune deficiency syndromes (1999)
影响因子: --
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影响因子: 4.2
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发表时间: 2008-03-01
影响因子: 1
作者:
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