Souza Araújo Outpatient Clinic, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
Leprosy Laboratory, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
PLoS Negl Trop Dis. 2021 May 3;15(5):e0009382. doi: 10.1371/journal.pntd.0009382. eCollection 2021 May.
The World Health Organization has raised concerns about the increasing number of Hansen disease (HD) relapses worldwide, especially in Brazil, India, and Indonesia that report the highest number of recurrent cases. Relapses are an indicator of MDT effectiveness and can reflect Mycobacterium leprae persistence or re-infection. Relapse is also a potential marker for the development or progression of disability. In this research, we studied a large cohort of persons affected by HD treated with full fixed-dose multibacillary (MB) multidrug therapy (MDT) followed for up to 20 years and observed that relapses are a rare event. We estimated the incidence density of relapse in a cohort of patients classified to receive MB regime (bacillary index (BI) > 0), diagnosed between September 1997 and June 2017, and treated with twelve-dose MB-MDT at a HD reference center in Rio de Janeiro, Brazil. We obtained the data from the data management system of the clinic routine service. We linked the selected cases to the dataset of relapses of the national HD data to confirm possible relapse cases diagnosed elsewhere. We diagnosed ten cases of relapse in a cohort of 713 patients followed-up for a mean of 12.1 years. This resulted in an incidence rate of 1.16 relapse cases per 1000 person-year (95% CI = 0.5915-2.076). The accumulated risk was 0.025 in 20 years. The very low risk observed in this cohort of twelve-dose-treated MB patients reinforces the success of the current MDT scheme.
世界卫生组织对全球范围内汉森病（HD）复发病例的不断增加表示担忧，尤其是巴西、印度和印度尼西亚这三个报告复发病例数最高的国家。复发是 MDT 有效性的指标，可能反映麻风分枝杆菌的持续存在或再感染。复发也是残疾发生或进展的潜在标志物。在这项研究中，我们研究了一个由大量接受过全剂量固定多菌型（MB）多药治疗（MDT）的 HD 患者组成的队列，这些患者的随访时间最长达 20 年，结果发现复发是一种罕见事件。我们在巴西里约热内卢的一个 HD 参考中心，对接受 MB 方案治疗的患者（细菌指数（BI）>0）队列进行了复发发生率密度的评估，该队列的患者于 1997 年 9 月至 2017 年 6 月间确诊，并接受了 12 剂 MB-MDT。我们从诊所常规服务的数据管理系统中获取了数据。我们将选定的病例与国家 HD 数据的复发数据集进行了关联，以确认在其他地方诊断的可能复发病例。我们在平均随访 12.1 年的 713 例患者队列中诊断出 10 例复发病例，导致发病率为每 1000 人年 1.16 例（95%CI=0.5915-2.076）。20 年内的累积风险为 0.025。在接受 12 剂治疗的 MB 患者队列中观察到的极低风险，进一步证实了当前 MDT 方案的成功。
