Brasil M T, Opromolla D V, Marzliak M L, Nogueira W
Leprosy Surveillance Service, State of São Paulo, Brazil.
Int J Lepr Other Mycobact Dis. 1996 Jun;64(2):97-104.
The implementation of the World Health Organization's multidrug therapy (WHO/MDT) in Brazil began slowly and gradually in 1986, and in 1991 it was adopted officially by the Brazilian Ministry for Health. After 1991, during the intensive phase of WHO/MDT implementation, there was some concern about the number of cases of renal failure observed in several Brazilian states, including some fatalities. This was the motive behind the state of São Paulo's Health Department's decision to carry out a study that would evaluate not only the incidence rate of adverse effects of rifampin in relation to kidney function but also in relation to the use of WHO/MDT in general. Due to the existence in the state of São Paulo of health services with a program for the control of Hansen's disease and an organized and stratified system of epidemiological surveillance, it was possible to elaborate a subsystem for data collecting. During the period from July 1991 to December 1993, 20,667 patients were treated with WHO/MDT. Among this group there were 127 notifications considered as adverse effects, mainly: "flu"-like syndrome (54), acute renal failure (20), cutaneous reactions (15), toxic hepatitis (15), gastrointestinal complaints (8), hemolytic anemia (6), methemoglobinemia (4), thrombocytopenic purpura (2), hypotension (2) and disseminated intravascular coagulation (1). There was a predominance of adverse effects among multibacillary (MB) patients and the majority of the reactions occurred before the 6th dose; 82.7% of MB patients had had previous treatment with dapsone and rifampin and, due the fact that most severe reactions were related to rifampin, a booster mechanism could be an explanation for this occurrence. So far, there are seven published reports on renal failure in the world, and in Brazil only in the state of Søao Paulo there were 20 cases reported among 20,667 patients under WHO/MDT treatment, This striking difference deserves a better explanation, but in no way do these reports undermine the positive aspects of WHO/MDT. However, the authors believe that a world alert about its possible serious side effects is not only necessary but ethically required.
世界卫生组织的多药疗法（WHO/MDT）于1986年在巴西缓慢且逐步地开始实施，并于1991年被巴西卫生部正式采用。1991年之后，在WHO/MDT实施的强化阶段，巴西几个州出现了一些肾衰竭病例，包括一些死亡病例，这引发了一些关注。这就是圣保罗州卫生部决定开展一项研究的动机，该研究不仅要评估利福平不良反应的发生率与肾功能的关系，还要评估其与总体使用WHO/MDT的关系。由于圣保罗州存在有麻风病控制项目的卫生服务机构以及有组织且分层的流行病学监测系统，因此有可能精心设计一个数据收集子系统。在1991年7月至1993年12月期间，20667名患者接受了WHO/MDT治疗。在这组患者中，有127例被视为不良反应通报，主要有：“流感”样综合征（54例）、急性肾衰竭（20例）、皮肤反应（15例）、中毒性肝炎（15例）、胃肠道不适（8例）、溶血性贫血（6例）、高铁血红蛋白血症（4例）、血小板减少性紫癜（2例）、低血压（2例）和弥散性血管内凝血（1例）。多菌型（MB）患者中不良反应占主导，且大多数反应发生在第6剂之前；82.7%的MB患者之前接受过氨苯砜和利福平治疗，由于大多数严重反应与利福平有关，一种增强机制可能是这种情况发生的原因。到目前为止，世界上有七篇关于肾衰竭的已发表报告，而在巴西，仅圣保罗州在20667名接受WHO/MDT治疗的患者中有20例报告。这种显著差异值得更好的解释，但这些报告绝没有削弱WHO/MDT的积极方面。然而，作者认为，对其可能的严重副作用发出全球警报不仅是必要的，而且在伦理上也是必需的。
