Gray D M, Workman L J, Lombard C J, Jennings T, Innes S, Grobbelaar C J, Cotton M F, Zar H J
Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa.
Biostatistics Unit, Medical Research Council, Cape Town, South Africa.
Int J Tuberc Lung Dis. 2014 Mar;18(3):322-7. doi: 10.5588/ijtld.13.0354.
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.
To assess the efficacy, tolerability and safety of isoniazid (INH) in HIV-infected children on ART.
A pilot randomised controlled study of INH was undertaken in HIV-infected children on ART. The primary outcome measure was TB disease or death.
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%).
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.
结核病是感染人类免疫缺陷病毒（HIV）儿童死亡和发病的常见原因。关于接受抗逆转录病毒治疗（ART）的HIV感染儿童中异烟肼预防性治疗（IPT）疗效的数据尚无定论。
评估异烟肼（INH）对接受ART的HIV感染儿童的疗效、耐受性和安全性。
对接受ART的HIV感染儿童进行了一项关于INH的试点随机对照研究。主要结局指标为结核病或死亡。
共有167名儿童被随机分组，分别接受INH（n = 85）或安慰剂（n = 82），并随访了34个月（四分位间距[IQR]24 - 52）。中位年龄为35个月（IQR 15 - 65）。接受INH治疗的儿童中有1例死亡，安慰剂组无死亡。发生了11例（6.6%）结核病病例，INH组4例（5%），安慰剂组7例（9%）。在结核病病例中，5例经培养确诊——INH组2例，安慰剂组3例，均对INH敏感。严重不良事件很少发生（n = 6；2%）。
在接受ART的HIV感染儿童中，IPT安全且耐受性良好。本研究支持需要进行更大规模的研究，以评估结核病流行地区HIV感染儿童的疗效。
