Balagon Marivic F, Cellona Roland V, Abalos Rodolfo M, Gelber Robert H, Saunderson Paul R
Leonard Wood Memorial Center for Leprosy Research, Cebu, Philippines.
Lepr Rev. 2010 Mar;81(1):27-33.
To compare the efficacy of a 4-week ofloxacin-containing regimen and the standard WHO-MDT regimen for PB leprosy, in terms of the rate and timing of relapse after treatment completion.
124 PB patients were enrolled in a randomised, double-blind trial. Of these, 66 received the standard 6-month WHO-MDT regimen, whereas 58 received 28 daily supervised doses of rifampicin 600mg + ofloxacin 400 mg, plus 5 months of placebo. Patients were regularly monitored for clinical response and for signs of relapse after treatment completion.
Patients enrolled in the ofloxacin group had a mean follow-up of 10.8 years (628 patient-years) with 1 early relapse at 3 years after treatment completion. On relapse, this patient remained smear negative but was reclassified by current WHO criteria (> or =6 skin lesions) as multibacillary (MB). Patients on the WHO-MDT regimen had a mean follow-up of 11.3 years (749 patient-years) with two late relapses at 8 and 12 years, both still classified as PB on relapse.
In conclusion, both regimens appeared generally efficacious, and, in particular, resulted in few relapses.
比较含氧氟沙星的4周治疗方案与世界卫生组织麻风病多药联合化疗（MDT）标准方案治疗结核样型（PB）麻风病的疗效，观察治疗结束后复发率及复发时间。
124例PB患者纳入一项随机双盲试验。其中，66例接受标准的6个月世界卫生组织MDT方案，而58例接受28次每日督导剂量的利福平600mg+氧氟沙星400mg，加5个月安慰剂治疗。定期监测患者的临床反应及治疗结束后的复发迹象。
氧氟沙星组患者平均随访10.8年（628患者年），治疗结束后3年有1例早期复发。复发时，该患者涂片仍为阴性，但根据现行世界卫生组织标准（≥6处皮肤损害）重新分类为多菌型（MB）。接受世界卫生组织MDT方案的患者平均随访11.3年（749患者年），8年和12年有2例晚期复发，复发时均仍分类为PB。
总之，两种方案总体上均显示有效，特别是复发较少。
