Manickam P, Nagaraju B, Selvaraj V, Balasubramanyam S, Mahalingam V N, Mehendale S M, Pannikar V K, Gupte M D
National Institute of Epidemiology (ICMR), R127, TNHB, Ayappakkam, Chennai-600 077, Tamil Nadu, India.
Indian J Lepr. 2012 Jul-Sep;84(3):195-207.
We conducted randomized double-blind trial for single-dose of Rifampicin, Ofloxacin and Minocycline (ROM) compared to WHO-PB-MDT among paucibacillary (PB) leprosy patients with 2-5 skin lesions. We enrolled 1526 patients from five centres (ROM=762; WHO-PB-MDT=764) and followed them for 36 months posttreatment during 1998-2003. We generated information on clearance of skin lesions and relapse rates per 100 person-years (PY) for all the five centres. At base-line, the patients in the two arms were comparable. Complete clearance of skin lesions was similar (72% vs. 72.1%; p=0.95) in both the arms. Clinical scores declined steadily and equally. Difference in relapse rates was statistically highly significant (ROM=1.13 and WHO-PB-MDT=0.35 per 100 PY; mid-p exact=0.001016). Twenty eight of 38 of these relapses occurred within 18 months. In all, 10 suspected adverse drug reactions were.observed (ROM=2; WHO-PB-MDT=8). We extended the follow-up to 48 months for 1082 of 1526 patients from two programme-based centres. No further relapses occurred. Decline in clinical score was not dependent on age, gender, number of lesions or affected body parts. Single dose ROM, though less effective than the standard WHO-PB-MDT regimen conceptually offers an alternative treatment regimen for PB leprosy patients with 2-5 lesions only when careful follow-up for relapse is possible. Registered at the Clinical Trials Registry of India;
CTRI/2012/05/002645
我们对2至5处皮肤损害的少菌型麻风患者进行了一项单剂量利福平、氧氟沙星和米诺环素（ROM）与世界卫生组织少菌型麻风联合化疗方案（WHO-PB-MDT）的随机双盲试验。我们从五个中心招募了1526名患者（ROM组=762人；WHO-PB-MDT组=764人），并在1998年至2003年期间对他们进行了36个月的治疗后随访。我们收集了所有五个中心皮肤损害清除情况及每100人年复发率的信息。在基线时，两组患者具有可比性。两组皮肤损害的完全清除情况相似（72%对72.1%；p=0.95）。临床评分稳步且同等程度下降。复发率差异具有高度统计学意义（ROM组每100人年为1.13，WHO-PB-MDT组为0.35；精确中位数p=0.001016）。这些复发事件中的38例中有28例发生在18个月内。总共观察到10例疑似药物不良反应（ROM组=2例；WHO-PB-MDT组=8例）。我们将来自两个项目中心的1526名患者中的1082名患者的随访延长至48个月。未再出现复发情况。临床评分的下降不取决于年龄、性别、损害数量或受累身体部位。单剂量ROM虽然在概念上不如标准的WHO-PB-MDT方案有效，但仅在能够对复发进行仔细随访的情况下，为仅有2至5处损害的少菌型麻风患者提供了一种替代治疗方案。在印度临床试验注册中心注册；
CTRI/2012/05/002645
