Lepr Rev. 1996 Dec;67(4):260-79.
During the period 1977-1983, clinical trials of five multidrug regimens were conducted among 215 patients with previously untreated multibacillary leprosy at the Institut Marchoux, Bamako, Mali, and the Central Leprosy Teaching and Research Institute, Chingleput, South India. The trials were designed primarily to permit measurement of the proportions of persisting Mycobacterium leprae in the patients' skin lesions. In addition, the combination of the large number of patients studied, the large volume of carefully standardized data, and the employment of multidrug regimens provided a unique opportunity to measure the clinical response of patients to treatment by these regimens. Persisting M. leprae were detected in 7.8% of all specimens; the frequency did not vary with centre, regimen, or duration of treatment. The bacterial index (BI) decreased by a mean annual rate of 75%, the logarithmic biopsy index by a mean annual rate of 87%, and the logarithm10 number of acid-fast bacilli per g tissue by a mean annual rate of 69%. The rate of decrease of these measures of the numbers of M. leprae was related to the 'strength' of the regimen. Although no difference of clinical status as a function of regimen was demonstrated, a difference was observed between the two centres, probably the result of different clinical criteria employed by the responsible physicians. A change of histopathological classification in the course of the trials was recorded for 12% of the patients, most representing upgrading from LLs to BL, without relation to regimen or treatment centre. ENL was less severe for the patients treated by the maximal regimen in Chingleput, which included daily clofazimine; as expected, the majority of patients treated by this regimen were found to have maximal pigmentation. Prednisolone was evidently preferred for treatment of ENL in Chingleput, whereas thalidomide was preferred in Bamako. Fourteen cases of jaundice were observed, primarily among the patients treated by the maximal regimens, that included daily administration of rifampicin for the entire two years of the trials. Measurements of weight and blood pressure, and studies of the blood and of hepatic and urinary tract function revealed only negligible differences among regimens and between centres. In many cases, those differences that were observed were associated with ENL.
1977年至1983年期间，在马里巴马科的马尔舒研究所和印度南部钦格利普特的中央麻风病教学与研究所，对215例先前未经治疗的多菌型麻风病患者进行了五种多药疗法的临床试验。这些试验主要旨在测定患者皮肤病变中持续存在的麻风分枝杆菌比例。此外，大量患者的研究、大量精心标准化的数据以及多药疗法的应用，为衡量患者对这些疗法的临床反应提供了独特的机会。在所有标本中，7.8%检测到有持续存在的麻风分枝杆菌；其频率在不同中心、疗法或治疗持续时间之间没有差异。细菌指数（BI）平均每年下降75%，对数活检指数平均每年下降87%，每克组织中抗酸杆菌的对数平均每年下降69%。这些衡量麻风分枝杆菌数量的指标的下降速率与疗法的“强度”有关。虽然未显示出临床状况因疗法不同而有差异，但在两个中心之间观察到了差异，这可能是负责医生采用不同临床标准的结果。在试验过程中，12%的患者组织病理学分类发生了变化，大多数是从LLs升级为BL，与疗法或治疗中心无关。在钦格利普特接受最大剂量疗法（包括每日服用氯法齐明）治疗的患者中，ENL症状较轻；正如预期的那样，接受该疗法治疗的大多数患者出现了最大程度的色素沉着。在钦格利普特，泼尼松龙显然更常用于治疗ENL，而在巴马科则更倾向使用沙利度胺。观察到14例黄疸病例，主要出现在接受最大剂量疗法治疗的患者中，这些疗法在整个两年的试验期间每日都使用利福平。体重和血压测量以及血液、肝脏和泌尿系统功能研究显示，不同疗法之间以及不同中心之间的差异微不足道。在许多情况下，观察到的这些差异与ENL有关。
