Effectiveness of single dose rifampicin in preventing leprosy in close contacts of patients with newly diagnosed leprosy: cluster randomised controlled trial
Effectiveness of single dose rifampicin in preventing leprosy in close contacts of patients with newly diagnosed leprosy: cluster randomised controlled trial
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DOI：
10.1136/bmj.39500.885752.be
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发表时间：
2008-04-05
影响因子：
105.7
通讯作者：
Richardus, Jan H.
中科院分区：
文献类型：
--
作者：
Moet, F. Johannes;Pahan, David;Richardus, Jan H.
目的 探讨单剂量利福平化学预防预防密切接触者麻风病的有效性。设计单中心、双盲、整群随机、安慰剂对照试验，在人口超过400万的孟加拉国西北部两个地区制定麻风病控制方案。研究对象为1037名新诊断麻风病患者的28 092名密切接触者。 21711 名接触者满足研究要求。 干预措施 在开始指示患者治疗的第二个月内，向密切接触者给予单剂利福平或安慰剂，并随访四年。 主要结局指标临床麻风病的发展。 结果 21711 名接触者中的 18 869 名 (86.9%) 在四年内进行了随访。安慰剂组的 9452 名接触者中有 91 人患有麻风病，利福平组的 9417 名接触者中有 59 人患有麻风病。头两年使用单剂利福平后麻风病发病率总体降低了 57%（95% 置信区间为 33% 至 72%）。这些组在两年和四年之间没有差异。为预防接触者中的一例麻风病而需要治疗 (NNT) 的总数为 297 例（95% 置信区间为 176 至 537）。亚组之间在两年内的发病率降低和 NNT 方面均存在差异。结论 对新诊断麻风病患者的接触者给予单剂利福平可有效预防两年内临床麻风的发展。效果得以维持，但安慰剂组和利福平组之间在两年后没有观察到差异。试验注册当前对照试验 ISRCTN61223447。
Objective To determine the effectiveness of chemoprophylaxis using a single dose of rifampicin to prevent leprosy in close contacts.Design Single centre, double blind, cluster randomised, placebo controlled trial.Setting Leprosy control programme in two districts of northwest Bangladesh with a population of more than four million.Participants 28 092 close contacts of 1037 patients with newly diagnosed leprosy. 21711 contacts fulfilled the study requirements.Interventions A single dose of rifampicin or placebo given to close contacts in the second month of starting the index patient's treatment, with follow-up for four years.Main outcome measure Development of clinical leprosy.Results 18 869 of the 21711 contacts (86.9%) were followed-up at four years. Ninety one of 9452 contacts in the placebo group and 59 of 9417 in the rifampicin group had developed leprosy. The overall reduction in incidence of leprosy using a single dose of rifampicin in the first two years was 57% (95% confidence interval 33% to 72%). The groups did not differ between two and four years. The overall number needed to treat (NNT) to prevent a single case of leprosy among contacts was 297 (95% confidence interval 176 to 537). Differences were found between subgroups at two years, both in reduction of incidence and in NNT.Conclusion A single dose of rifampicin given to contacts of patients with newly diagnosed leprosy is effective at preventing the development of clinical leprosy at two years. The effect was maintained, but no difference was seen between the placebo and rifampicin groups beyond two years.Trial registration Current Controlled Trials ISRCTN61223447.