Pönnighaus J M, Boerrigter G
Universitats-Hautklinik, Homburg, Saar, Germany.
Int J Lepr Other Mycobact Dis. 1995 Mar;63(1):1-7.
A trial comparing 18 monthly and 30 monthly doses of the World Health Organization-recommended multidrug therapy (WHO/MDT) in 305 multibacillary leprosy patients in Malawi is described. Patients were randomly allocated to one of the two regimens at the time of taking the 18th supervised dose of WHO/MDT. The mean follow-up period was 3 years (maximum 6 years). No relapse was observed in either group. The cumulative probabilities of remaining slit-skin smear positive were significantly higher among patients receiving only the 18 monthly doses of WHO/MDT, but reached zero at month 60 of follow up. The percentage of patients who developed new disabilities during the trial period was similar in both groups. However, the overall percentage of patients who developed new disabilities (50/305, 16.4%) remains disturbingly high. On the whole, the results of the trial argue in favor of 18 monthly doses of WHO/MDT taken within 24 months as being sufficient for the treatment of multibacillary leprosy.
本文描述了一项在马拉维对305例多菌型麻风病患者进行的试验，该试验比较了世界卫生组织推荐的多药联合疗法（WHO/MDT）的两种服药方案，即分别服用18个月剂量和30个月剂量。患者在服用第18次监督剂量的WHO/MDT时被随机分配到两种方案之一。平均随访期为3年（最长6年）。两组均未观察到复发情况。仅接受18个月剂量WHO/MDT的患者中，皮肤涂片持续阳性的累积概率显著更高，但在随访第60个月时降至零。试验期间出现新残疾的患者百分比在两组中相似。然而，出现新残疾的患者总体百分比（50/305，16.4%）仍然高得令人不安。总体而言，该试验结果表明，在24个月内服用18个月剂量的WHO/MDT足以治疗多菌型麻风病。
