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常规项目条件下持续单剂量利福平暴露后预防(SDR-PEP)实施的有效性——尼泊尔的一项观察性研究

Effectiveness of ongoing single dose rifampicin post-exposure prophylaxis (SDR-PEP) implementation under routine programme conditions-An observational study in Nepal.

作者信息

Banstola Nand Lal, Hasker Epco, Mieras Liesbeth, Gurung Dambar, Baral Bhuwan, Mehata Suresh, Prasai Sagar, Ghimire Yograj, Das Brij Kumar, Napit Prashnna, van Brakel Wim

机构信息

Programme department, NLR, Biratnagar, Koshi, Nepal.

Mycobacterial Diseases and Neglected Tropical Diseases, Institute of Tropical Medicine, Antwerp, Belgium.

出版信息

PLoS Negl Trop Dis. 2024 Dec 4;18(12):e0012446. doi: 10.1371/journal.pntd.0012446. eCollection 2024 Dec.

Abstract

BACKGROUND/INTRODUCTION: Leprosy control remains a challenge in Nepal. Single-dose rifampicin post-exposure prophylaxis (SDR-PEP) shows promise in reducing leprosy incidence among contacts of index cases, contributing to reducing the transmission of Mycobacterium (M.) leprae. This study evaluates the effectiveness of routine SDR-PEP implementation in Nepal in addition to contact screening, focusing on its impact on reducing leprosy risk among contacts and potential population-level effects.

METHODOLOGY

We conducted a retrospective cohort study to compare leprosy case notification rates and leprosy risk among close contacts. We compared two districts implementing SDR-PEP (the intervention group) and two without (the comparator group). Data from 2015 onwards included demographics, index case types, and contact relationships. Statistical analyses, including Cox regression and Kaplan-Meier survival curves, assessed the impact of SDR-PEP implementation.

FINDINGS

All four districts showed a decrease in case notification rates since 2015, with the steepest decline in the intervention districts. The risk of developing leprosy among contacts was significantly lower in the intervention districts (HR 0.28, 95% CI 0.18-0.44). SDR-PEP offered 72% protection, consistent over time, as shown in Kaplan-Meier plots. The protective effect was equally strong in blood-related contacts (HR 0.29 versus 0.27 in others, p = 0.32), and the proportion of MB cases among incident cases was not significantly different post-PEP (51.4% vs. 53.6%, p = 0.82).

CONCLUSIONS

This study demonstrates the substantial protective effect of integrating SDR-PEP in routine leprosy control programs with contact screening, significantly lowering leprosy risk among contacts. SDR-PEP is equally effective for blood-related contacts and does not preferentially prevent PB cases. While suggesting potential population-level impact, the study design does not allow for firm conclusions at this level. Further research is needed to fully assess SDR-PEP's effectiveness in diverse contexts and optimize its implementation. Integrating SDR-PEP within well-organized contact screening programs is effective and is expected to reduce leprosy transmission when applied as a rolling intervention.

摘要

背景/引言:在尼泊尔,麻风病防控仍是一项挑战。单剂量利福平暴露后预防(SDR-PEP)在降低索引病例接触者中的麻风病发病率方面显示出前景,有助于减少麻风分枝杆菌的传播。本研究评估了尼泊尔除接触者筛查外常规实施SDR-PEP的有效性,重点关注其对降低接触者麻风病风险的影响以及潜在的人群水平效应。

方法

我们进行了一项回顾性队列研究,以比较麻风病病例报告率和密切接触者中的麻风病风险。我们比较了两个实施SDR-PEP的地区(干预组)和两个未实施的地区(对照组)。2015年起的数据包括人口统计学、索引病例类型和接触关系。统计分析,包括Cox回归和Kaplan-Meier生存曲线,评估了SDR-PEP实施的影响。

结果

自2015年以来,所有四个地区的病例报告率均有所下降,干预地区下降最为显著。干预地区接触者患麻风病的风险显著更低(风险比0.28,95%置信区间0.18 - 0.44)。如Kaplan-Meier图所示,SDR-PEP提供了72%的保护,且随时间保持一致。在血亲接触者中保护作用同样显著(风险比0.29,其他接触者为0.27,p = 0.32),暴露后发病病例中多菌型病例的比例无显著差异(51.4%对53.6%,p = 0.82)。

结论

本研究表明,将SDR-PEP纳入常规麻风病防控项目并结合接触者筛查具有显著的保护作用,能显著降低接触者中的麻风病风险。SDR-PEP对血亲接触者同样有效,且不会优先预防少菌型病例。虽然提示了潜在的人群水平影响,但本研究设计无法在此层面得出确凿结论。需要进一步研究以全面评估SDR-PEP在不同环境下的有效性并优化其实施。将SDR-PEP纳入组织良好的接触者筛查项目是有效的,作为滚动式干预措施应用时有望减少麻风病传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/856b/11649142/5ca5e1643d28/pntd.0012446.g001.jpg

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