Isoniazid preventive therapy in HIV-infected children on antiretroviral therapy: a pilot study
Isoniazid preventive therapy in HIV-infected children on antiretroviral therapy: a pilot study
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DOI：
10.5588/ijtld.13.0354
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发表时间：
2014-03-01
影响因子：
4
通讯作者：
Zar, H. J.
中科院分区：
文献类型：
--
作者：
Gray, D. M.;Workman, L. J.;Zar, H. J.
背景：结核病（TB）是感染人类免疫缺陷病毒（HIV）的儿童死亡和发病的常见原因。异烟肼预防性治疗（IPT）在接受抗逆转录病毒治疗（ART）的HIV感染儿童的疗效数据是inconclusive.OBJECTIVE：为了评估异烟肼（INH）在HIV感染儿童ART. DESIGN的有效性，耐受性和安全性在HIV感染儿童ART. The主要结局措施是结核病或死亡的INH进行了试点随机对照研究。研究结果：共有167名儿童随机接受INH（n = 85）或安慰剂（n = 82），中位随访时间为34个月（四分位距[IQR] 24-52）。中位年龄为35个月（IQR 15-65）。INH组有一名儿童死亡，安慰剂组没有死亡。发生11例（6.6%）结核病，INH组4例（5%），安慰剂组7例（9%）。在结核病病例中，5例经培养证实--异烟肼组2例，安慰剂组3例，均对异烟肼敏感。严重的不良事件很少发生（n = 6; 2%）。结论：IPT是安全的，耐受性良好的艾滋病毒感染的儿童同时ART. This研究支持需要一个更大的研究，以评估疗效艾滋病毒感染的儿童生活在结核病流行地区。
SETTING: Tuberculosis (TB) is a common cause of mortality and morbidity in children infected with the human immunodeficiency virus (HIV). Data on isoniazid preventive therapy (IPT) efficacy in HIV-infected children receiving antiretroviral therapy (ART) are inconclusive.OBJECTIVE: To assess the efficacy, tolerability and safety of isoniazid (INH) in HIV-infected children on ART. DESIGN: A pilot randomised controlled study of INH was undertaken in HIV-infected children on ART. The primary outcome measure was TB disease or death. RESULTS: A total of 167 children were randomised to receive INH (n = 85) or placebo (n = 82), and followed for a median of 34 months (interquartile range [IQR] 24-52). The median age was 35 months (IQR 15-65). There was one death in a child on INH and none in the placebo group. Eleven (6.6%) cases of TB occurred, 4 (5%) in the INH and 7 (9%) in the placebo group. Among the TB cases, 5 were culture confirmed-2 in the INH group and 3 in the placebo group, all susceptible to INH. Severe adverse events occurred rarely (n = 6; 2%).CONCLUSION: IPT is safe and well tolerated in HIV-infected children on concomitant ART. This study supports the need for a larger study to assess efficacy in HIV-infected children living in TB-endemic areas.