From the Department of Pharmacology, All Indian Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Department of Pediatrics, All Indian Institute of Medical Science, Rishikesh, Uttrakhand, India.
Pediatr Infect Dis J. 2018 Aug;37(8):773-780. doi: 10.1097/INF.0000000000001879.
Isoniazid is recommended for prevention of tuberculosis (TB) in HIV-infected adults, but its efficacy in children living with HIV (CLHIV) is not known. We performed a systematic review to assess the efficacy of isoniazid for the prevention of TB in CLHIV.
We searched PubMed, Cochrane Clinical Trial Registry and Google Scholar from inception to December 2016. Any randomized controlled trial assessing the role of isoniazid for the prevention of TB in CLHIV was eligible for inclusion. The primary endpoint was TB incidence; secondary end points were mortality, overall survival and severe adverse events. Dual independent extraction of all data was performed. Data were pooled under a random effects model and summarized either as risk ratio (RR) or hazard ratio along with 95% confidence intervals (CIs).
Of 931 references, 3 randomized controlled trials enrolling 977 patients met the inclusion criteria. Pooled results showed a statistically nonsignificant reduction in TB incidence (RR: 0.70; 95% CI: 0.47-1.04; P = 0.07) and mortality (RR: 0.94; 95% CI: 0.39-2.23; P = 0.88) with the use of isoniazid compared with placebo. One study was stopped early because of excess deaths in the placebo arm. However, results from subgroup analysis restricted to only completed trials did not change the overall findings.
Isoniazid did not reduce the incidence of TB in CLHIV. All included studies were performed in regions with high prevalence of TB making the overall generalizability limited.
异烟肼被推荐用于预防 HIV 感染者中的结核病（TB），但其在 HIV 感染儿童（CLHIV）中的疗效尚不清楚。我们进行了一项系统评价，以评估异烟肼预防 CLHIV 中结核病的疗效。
我们从开始到 2016 年 12 月在 PubMed、Cochrane 临床试验注册中心和 Google Scholar 进行了搜索。任何评估异烟肼预防 CLHIV 中结核病作用的随机对照试验均符合纳入标准。主要终点是结核病发病率；次要终点是死亡率、总生存率和严重不良事件。对所有数据进行了双重独立提取。数据采用随机效应模型进行汇总，并以风险比（RR）或风险比（HR）及其 95%置信区间（CI）表示。
在 931 篇参考文献中，有 3 项随机对照试验纳入了 977 名患者符合纳入标准。汇总结果显示，与安慰剂相比，异烟肼的使用并未显著降低结核病发病率（RR：0.70；95%CI：0.47-1.04；P = 0.07）和死亡率（RR：0.94；95%CI：0.39-2.23；P = 0.88）。一项研究因安慰剂组死亡人数过多而提前终止。然而，仅对完成的试验进行亚组分析的结果并未改变总体发现。
异烟肼并未降低 CLHIV 中结核病的发病率。所有纳入的研究均在结核病高发地区进行，因此总体推广性有限。
