Indian J Lepr. 1997 Apr-Jun;69(2):121-9.
A multicentre double-blind controlled clinical trial was carried out to compare the efficacy of a combination of rifampicin 600 mg plus ofloxacin 400 mg plus minocycline 100 mg (ROM) administered as single dose with that of the standard six-month WHO/MDT/PB regimen. The subjects included 1483 cases with one skin lesion who were previously untreated, were smear-negative, and had no evidence of peripheral nerve trunk involvement, and they were randomly divided into study and control groups. The total duration of the study from the day of intake was 18 months, and 1381 patients completed study. Only 12 patients were categorized as treatment failure and no difference was observed between the two regimens. Occurrence of mild side-effects and leprosy reactions were minimal (less than 1%) in both groups. This study showed that ROM is almost as effective as the standard WHO/MDT/PB in the treatment of single lesion PB leprosy.
开展了一项多中心双盲对照临床试验，以比较利福平600毫克加氧氟沙星400毫克加米诺环素100毫克（ROM）单剂量联合用药与世界卫生组织/多药联合化疗/少菌型标准六个月疗程的疗效。研究对象包括1483例此前未接受过治疗、涂片阴性且无周围神经干受累证据的单发皮肤损害患者，他们被随机分为研究组和对照组。从摄入药物当天起，研究总时长为18个月，1381名患者完成了研究。仅有12例患者被归类为治疗失败，两种治疗方案之间未观察到差异。两组中轻度副作用和麻风反应的发生率均极低（低于1%）。本研究表明，ROM在治疗单发少菌型麻风方面几乎与世界卫生组织/多药联合化疗/少菌型标准疗法同样有效。
