Núcleo de Medicina Tropical, Universidade de Brasília, Brasília, DF, Brasil.
Mem Inst Oswaldo Cruz. 2012 Dec;107 Suppl 1:22-7. doi: 10.1590/s0074-02762012000900005.
Leprosy will continue to be a public health problem for several decades. The World Health Organization (WHO) recommends that, for treatment purposes, leprosy cases be classified as either paucibacillary or multibacillary (MB). A uniform leprosy treatment regimen would simplify treatment and halve the treatment duration for MB patients. The clinical trial for uniform multidrug therapy (U-MDT) for leprosy patients (LPs) in Brazil is a randomised, open-label clinical trial to evaluate if the effectiveness of U-MDT for leprosy equals the regular regimen, to determine the acceptability of the U-MDT regimen and to identify the prognostic factors. This paper details the clinical trial methodology and patient enrolment data. The study enrolled 858 patients at two centres and 78.4% of participants were classified as MB according to the WHO criteria. The main difficulty in evaluating a new leprosy treatment regimen is that no reliable data are available for the current treatment regimen. Relapse, reaction and impaired nerve function rates have never been systematically determined, although reaction and impaired nerve function are the two major causes of nerve damage that lead to impairments and disabilities in LPs. Our study was designed to overcome the need for reliable data about the current treatment and to compare its efficacy with that of a uniform regimen.
麻风病在未来几十年仍将是一个公共卫生问题。世界卫生组织（WHO）建议，为治疗目的，麻风病例应分为少菌型和多菌型（MB）。统一的麻风病治疗方案将简化治疗，并将 MB 患者的治疗时间缩短一半。巴西的麻风病患者统一多药物治疗（U-MDT）临床试验是一项随机、开放性临床试验，旨在评估 U-MDT 治疗麻风病的效果是否等同于常规方案，确定 U-MDT 方案的可接受性，并确定预后因素。本文详细介绍了临床试验的方法学和患者入组数据。该研究在两个中心共招募了 858 名患者，根据世界卫生组织的标准，78.4%的参与者被归类为 MB。评估新的麻风病治疗方案的主要困难在于，目前的治疗方案缺乏可靠的数据。复发、反应和神经功能障碍的发生率从未被系统地确定过，尽管反应和神经功能障碍是导致麻风病患者神经损伤、残疾的两个主要原因。我们的研究旨在克服对现有治疗方法的可靠数据的需求，并将其疗效与统一方案进行比较。
