Background

Vaccination and single-dose rifampin are the main proven effective intervention types for preventing leprosy among contacts of Mycobacterium leprae endemic areas. Currently, no high-quality evidence is available regarding the best prophylactic intervention.

Objectives

Our primary study aim is to detect the most effective prophylactic intervention for the prevention of leprosy.

Methods

In May 2019, 12 databases were searched systematically. Updated search terms were developed in March 2020 to complete an updated search. All randomized controlled trials (RCTs) comparing the different types of chemoprophylactic and immunoprophylactic interventions in leprosy prevention were included. Our participants were contacts of patients with leprosy or people residing in leprosy endemic communities. We searched for different types of chemoprophylactic and immunoprophylactic interventions used in leprosy prevention. We used network meta-analysis and meta-analysis. Quality assessment was performed using Cochrane Risk of Bias for included RCTs, in which all included RCTs were rated to be low to moderate risk. We registered our protocol in Prospero with ID CRD42019143207.

Results

Among 11 included studies (326 264 patients) from original and updated search terms, eight were eligible for network meta-analysis (NMA) while four were eligible for MA. Findings suggest that Bacillus Calmette–Guérin (BCG) vaccination was the most effective intervention compared to placebo (risk ratios (RRs) 0.49 (0.30, 0.80), p 0.77), followed by combined BCG vaccination and single-dose rifampicin (SDR) with similarly low values (RR 48%, p 0.77). BCG revaccination was the least effective intervention compared to placebo (RR 1.08 (0.36, 3.22), p 0.26).

Conclusion

Compared to placebo, the BCG vaccine was the most effective prophylactic intervention. The combination of BCG vaccination + SDR had nearly the same efficacy as BCG vaccination alone, while BCG revaccination was the least effective. Thus, vaccination proved to be a more effective treatment than SDR alone. A well-designed multicenter RCT is warranted to evaluate the safety of these vaccines.

中文翻译：

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麻风病预防中化学预防和免疫预防的功效：随机对照试验的系统评价和网络荟萃分析

背景

疫苗接种和单剂量利福平是预防麻风分枝杆菌流行区接触者麻风病的主要被证明有效的干预类型。目前，没有关于最佳预防干预的高质量证据。

目标

我们的主要研究目的是发现预防麻风病的最有效的预防性干预措施。

方法

2019年5月，系统检索了12个数据库。更新的搜索词于 2020 年 3 月开发，以完成更新的搜索。所有比较麻风预防中不同类型的化学预防和免疫预防干预措施的随机对照试验（RCT）都被纳入。我们的参与者是麻风病患者或居住在麻风病流行社区的人的接触者。我们搜索了用于麻风预防的不同类型的化学预防和免疫预防干预。我们使用网络荟萃分析和荟萃分析。使用 Cochrane 偏倚风险对纳入的 RCT 进行质量评估，其中所有纳入的 RCT 均被评为低至中等风险。我们在 Prospero 中注册了我们的协议，ID 为 CRD42019143207。

结果

在来自原始和更新搜索词的 11 项纳入研究（326 264 名患者）中，8 项符合网络荟萃分析（NMA）的条件，4 项符合 MA 的条件。研究结果表明，与安慰剂相比，卡介苗 (BCG) 疫苗接种是最有效的干预措施（风险比 (RRs) 0.49 (0.30, 0.80)，p = 0.77），其次是卡介苗疫苗和单剂量利福平 (SDR)同样低的值（RR 48%，p = 0.77）。与安慰剂相比，卡介苗重新接种是最不有效的干预措施（RR 1.08 (0.36, 3.22)，p = 0.26）。

结论

与安慰剂相比，卡介苗疫苗是最有效的预防性干预措施。BCG疫苗+SDR的组合与单独BCG疫苗的效果几乎相同，而BCG再次接种的效果最差。因此，接种疫苗被证明是比单独使用 SDR 更有效的治疗方法。有必要进行精心设计的多中心 RCT 来评估这些疫苗的安全性。