Sanitas University Foundation, Bogota, Colombia.
Rev Panam Salud Publica. 2009 Oct;26(4):341-9. doi: 10.1590/s1020-49892009001000009.
To identify and summarize randomized clinical trials (RCTs) that assessed the effectiveness of chemoprophylaxis to prevent leprosy in contacts of patients newly diagnosed with the disease.
All studies were extracted from Medline (PubMed 1966 to November 2008), the Cochrane Controlled Trials Register (number 3 2008), LILACS (1982 to November 2008), and Scirus (November 2008). Manual searches and searches of crossed references of assessed articles were also done. RCTs' risk of bias was assessed according to the methodology proposed by the Cochrane Collaboration. The main outcome measure was diagnosis of leprosy (secondary cases) in contacts of patients with the disease (primary cases).
The search identified 320 references, from which 7 RCTs with a total of 66 311 participants were included and evaluated. The combined results from the RCTs favored chemoprophylaxis to placebo with 2-4 years of follow-up (6 RCTs, 66 107 participants, relative risk (RR) 0.59, 95% confidence interval (CI) 0.50-0.70, I(2) = 0 (I(2) describes percent total variation across studies caused by heterogeneity)). Single-dose rifampicin (21 711 participants, RR 0.43, 95% CI 0.28-0.67, number needed to treat 285), dapsone once or twice weekly for at least 2 years (3 RCTs, 43 137 participants, RR 0.60, 95% CI 0.48-0.76, I(2) = 0), and acedapsone every 10 weeks for 7 months (2 RCTs, 1 259 participants, RR 0.49, 95% CI 0.33-0.72, I(2) = 0) were significantly superior to placebo in preventing secondary cases of leprosy.
Chemoprophylaxis is effective in lowering the incidence of leprosy in contacts of patients diagnosed with the disease.
确定并总结评估新诊断为麻风病患者的接触者使用化学预防以预防麻风病的有效性的随机临床试验(RCT)。
所有研究均从 Medline(PubMed 1966 年至 2008 年 11 月)、Cochrane 对照试验登记处(第 3 期 2008 年)、LILACS(1982 年至 2008 年 11 月)和 Scirus(2008 年 11 月)中提取。还进行了手工检索和评估文章的交叉引用检索。根据 Cochrane 协作组提出的方法评估 RCT 的偏倚风险。主要结局指标是疾病患者(原发性病例)接触者的麻风病(继发性病例)诊断。
检索共识别出 320 篇参考文献,其中纳入并评估了 7 项 RCT,共计 66311 名参与者。7 项 RCT 的综合结果均支持化学预防优于安慰剂(2-4 年随访)(6 项 RCT,66107 名参与者,相对风险(RR)0.59,95%置信区间(CI)0.50-0.70,I²=0(I² 描述研究间由于异质性导致的总变异百分比))。单剂利福平(21711 名参与者,RR 0.43,95%CI 0.28-0.67,需要治疗人数 285)、每周一次或两次至少 2 年的氨苯砜(3 项 RCT,43137 名参与者,RR 0.60,95%CI 0.48-0.76,I²=0)和每 10 周 7 个月的乙酰氨苯砜(2 项 RCT,1259 名参与者,RR 0.49,95%CI 0.33-0.72,I²=0)在预防麻风病继发性病例方面明显优于安慰剂。
化学预防可有效降低新诊断为麻风病患者接触者的麻风病发病率。