Mane I, Cartel J L, Grosset J H
Institut de Leprologie Appliquee, Dakar CD Annexe, Senegal.
Int J Lepr Other Mycobact Dis. 1997 Jun;65(2):224-9.
In 1995, a field trial was implemented in Senegal in order to evaluate the efficacy of a regimen based on the monthly supervised intake of rifampin 600 mg, ofloxacin 400 mg and minocycline 100 mg to treat leprosy. During the first year of the trial, 220 patients with active leprosy (newly detected or relapsing after dapsone monotherapy) were recruited: 102 paucibacillary (PB) (60 males and 42 females) and 118 multibacillary (MB) (71 males and 47 females). All of them accepted the new treatment (none requested to be preferably put under standard WHO/MDT), no clinical sign which could be considered as a toxic effect of the drug was noted, and none of the patients refused to continue treatment because of any clinical trouble. The compliance was excellent: the 113 patients (PB and MB) detected during the first 6 months of the trial have taken six monthly doses in 6 months, as planned. The rate of clearance and the progressive decrease of cutaneous lesions was satisfactory. Although it is too soon to give comprehensive results, it should be noted that no treatment failure was observed in the 56 PB patients who have completed treatment and have been followed up for 6 months. The long-term efficacy of the new regimen is to be evaluated on the rate of relapse during the years following the cessation of treatment. If that relapse rate is acceptable (similar to that observed in patients after treatment with current standard WHO/ MDT), the new regimen could be a solution to treat, for instance, patients very irregular and/or living in remote or inaccessible areas since no selection of rifampin-resistant Mycobacterium leprae should be possible (a monthly dose of ofloxacin and minocycline being as effective as a dose of dapsone and clofazimine taken daily for 1 month). Nevertheless, until longer term results of this and other trials become available, there is no justification for any change in the treatment strategy, and all leprosy patients should be put under standard WHO/MDT.
1995年，在塞内加尔开展了一项现场试验，以评估基于每月监督服用600毫克利福平、400毫克氧氟沙星和100毫克米诺环素的方案治疗麻风病的疗效。在试验的第一年，招募了220例活动性麻风病患者（新发现的或在单药氨苯砜治疗后复发的）：102例少菌型（PB）（60例男性和42例女性）和118例多菌型（MB）（71例男性和47例女性）。他们都接受了新治疗（无人要求优先接受世界卫生组织/多药联合化疗标准方案），未发现可被视为药物毒性作用的临床体征，也没有患者因任何临床问题而拒绝继续治疗。依从性极佳：在试验的前6个月发现的113例患者（PB和MB）按计划在6个月内服用了6个月度剂量。清除率和皮肤损害的逐渐减少情况令人满意。虽然现在给出全面结果还为时过早，但应注意到，在完成治疗并随访6个月的56例PB患者中未观察到治疗失败。新方案的长期疗效将根据治疗停止后数年的复发率来评估。如果该复发率可以接受（与目前世界卫生组织/多药联合化疗标准方案治疗后的患者中观察到的复发率相似），则新方案可能成为治疗例如非常不规律和/或生活在偏远或难以到达地区的患者的一种解决方案，因为不可能出现对利福平耐药的麻风分枝杆菌（每月一剂氧氟沙星和米诺环素与每日一剂氨苯砜和氯法齐明服用1个月一样有效）。然而，在获得该试验和其他试验的长期结果之前，没有理由改变治疗策略，所有麻风病患者都应接受世界卫生组织/多药联合化疗标准方案治疗。
