A Trial of Mass Isoniazid Preventive Therapy for Tuberculosis Control
A Trial of Mass Isoniazid Preventive Therapy for Tuberculosis Control
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DOI：
10.1056/nejmoa1214289
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发表时间：
2014-01-23
影响因子：
158.5
通讯作者：
Grant, Alison D.
中科院分区：
文献类型：
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作者：
Churchyard, Gavin J.;Fielding, Katherine L.;Grant, Alison D.
结核病在南非金矿工人中流行。我们评估了一种干预措施，通过与活动性疾病或潜伏性感染治疗相关的大规模筛查来阻断结核病传播。在一项集群随机研究中，我们指定了15个集群，78,744名矿工作为干预集群（8个集群中有40,981名矿工）或控制集群（7个集群中有37,763名矿工）。在干预组中，所有矿工都接受了结核病筛查。如果确诊为活动性肺结核，他们将接受治疗；如果没有，则给予9个月的异烟肼预防治疗。主要结果是干预结束后12个月内的集群水平结核病发病率。次要结果包括研究结束时的结核病患病率。结果在干预组中，有27126名矿工接受了筛查，占66.2%。在这些矿工中，23,659人（87.2%）开始服用异烟肼，35 - 79%的矿工服用异烟肼的时间为6个月或更长。干预并没有降低结核病的发病率，干预组的发病率为3.02 / 100人-年，对照组为2.95 / 100人-年（干预组的发病率比为1.00；95%可信区间[CI]为0.75 - 1.34；P=0.98；调整后的发病率比为0.96；95% CI为0.76 - 1.21；P=0.71），也没有降低结核病的患病率（2.35% vs. 2.14%；调整后的患病率比为0.98；95% CI为0.65 - 1.48；P=0.90）。对10909名矿工使用异烟肼的直接效果分析显示，治疗期间结核病发病率降低（使用异烟肼的矿工每100人年发病率为1.10例，对照组为2.91例；调整后的比率为0.42；95% CI为0.20 ~ 0.88；P=0.03），但随后保护作用迅速丧失。结论南非金矿在治疗过程中使用异烟肼有效预防结核病，但对潜伏性结核病的大规模筛查和治疗对结核病控制没有显著效果。
BackgroundTuberculosis is epidemic among workers in South African gold mines. We evaluated an intervention to interrupt tuberculosis transmission by means of mass screening that was linked to treatment for active disease or latent infection.MethodsIn a cluster-randomized study, we designated 15 clusters with 78,744 miners as either intervention clusters (40,981 miners in 8 clusters) or control clusters (37,763 miners in 7 clusters). In the intervention clusters, all miners were offered tuberculosis screening. If active tuberculosis was diagnosed, they were referred for treatment; if not, they were offered 9 months of isoniazid preventive therapy. The primary outcome was the cluster-level incidence of tuberculosis during the 12 months after the intervention ended. Secondary outcomes included tuberculosis prevalence at study completion.ResultsIn the intervention clusters, 27,126 miners (66.2%) underwent screening. Of these miners, 23,659 (87.2%) started taking isoniazid, and isoniazid was dispensed for 6 months or more to 35 to 79% of miners, depending on the cluster. The intervention did not reduce the incidence of tuberculosis, with rates of 3.02 per 100 person-years in the intervention clusters and 2.95 per 100 person-years in the control clusters (rate ratio in the intervention clusters, 1.00; 95% confidence interval [CI], 0.75 to 1.34; P=0.98; adjusted rate ratio, 0.96; 95% CI, 0.76 to 1.21; P=0.71), or the prevalence of tuberculosis (2.35% vs. 2.14%; adjusted prevalence ratio, 0.98; 95% CI, 0.65 to 1.48; P=0.90). Analysis of the direct effect of isoniazid in 10,909 miners showed a reduced incidence of tuberculosis during treatment (1.10 cases per 100 person-years among miners receiving isoniazid vs. 2.91 cases per 100 person-years among controls; adjusted rate ratio, 0.42; 95% CI, 0.20 to 0.88; P=0.03), but there was a subsequent rapid loss of protection.ConclusionsMass screening and treatment for latent tuberculosis had no significant effect on tuberculosis control in South African gold mines, despite the successful use of isoniazid in preventing tuberculosis during treatment.