Clinical data on 29 patients with leprosy.

IntroductionThe World Health Organization (WHO) recommends rifampicin, dapsone and clofazimine multi-drug therapy (MDT) for the treatment of leprosy. Severe adverse effects include dapsone hypersensitivity syndrome, skin pigmentation, haemolytic anaemia, and hepatitis. At the Hospital for Tropical Diseases (HTD), London, United Kingdom monthly rifampicin, ofloxacin and minocycline (mROM) is used as first line treatment for leprosy.ObjectivesTo determine the clinical outcomes and experiences of individuals treated with mROM.MethodsA retrospective study of individuals with leprosy who were prescribed mROM at HTD was conducted. Demographic and clinical data were collected on outcomes including relapses, leprosy reactions, bacterial index (BI) and adverse effects. Individuals were interviewed using a semi-structured questionnaire to understand their experiences of mROM.Results29 individuals were identified and 20 interviewed. 26 (89.7%) individuals completed monthly mROM. 9 (31%) had switched from WHO MDT to mROM (five of whom (55.6%) were interviewed). BI reduced significantly following mROM treatment (p = 0.04). 17 individuals (58.6%) experienced a leprosy reaction. One of the 29 (3.4%) relapsed. The relapse rate was 9.5/1000 person years. 49 reports of adverse effects were either mild or moderate. The most frequent adverse effect (14/49) reported was orange discolouration of urine. No adverse effect required hospitalisation or discontinuation of mROM. Most individuals reported that skin lesions improved by the time they had completed mROM.ConclusionsIn this small study in a non-endemic setting mROM was safe, effective and acceptable. mROM therapy is associated with improvement in skin lesions, decline in bacterial index and acceptable adverse effects. Larger, prospective, randomised studies are needed to determine whether relapse rates with mROM are equivalent or better than WHO MDT and to provide robust data on the seemingly better adverse effect profile of mROM.

引言
世界卫生组织（World Health Organization, WHO）推荐采用利福平、氨苯砜与氯法齐明联合多药治疗（multi-drug therapy, MDT）方案治疗麻风病，其严重不良反应包括氨苯砜超敏综合征、皮肤色素沉着、溶血性贫血及肝炎。英国伦敦热带病医院（Hospital for Tropical Diseases, HTD）将每月一次的利福平、氧氟沙星与米诺环素联合疗法（monthly rifampicin, ofloxacin and minocycline, mROM）作为麻风病的一线治疗方案。

研究目的
明确接受mROM治疗的麻风病患者的临床结局与治疗体验。

研究方法
本研究为回顾性研究，纳入在伦敦热带病医院开具mROM治疗处方的麻风病患者。收集患者的人口统计学与临床数据，评估指标包括复发情况、麻风反应、细菌指数（bacterial index, BI）及不良反应。采用半结构化问卷对患者进行访谈，以了解其接受mROM治疗的相关体验。

研究结果
本研究共纳入29例患者，其中20例接受了访谈。26例（89.7%）患者完成了全程每月一次的mROM治疗。9例（31%）患者由WHO推荐的MDT方案转换为mROM治疗（其中5例接受访谈，占比55.6%）。接受mROM治疗后，患者的细菌指数显著下降（p=0.04）。17例（58.6%）患者出现麻风反应。29例患者中1例（3.4%）出现复发，复发率为9.5/1000人年。共报告49例次不良反应，均为轻度或中度；最常见的不良反应为尿液橙染（14/49）。无不良反应导致患者住院或停用mROM治疗。多数患者表示，完成mROM治疗后皮肤皮损得到改善。

研究结论
在这项非麻风病流行地区开展的小型研究中，mROM治疗展现出良好的安全性、有效性与患者接受度。mROM治疗可改善皮肤皮损、降低细菌指数，且不良反应可耐受。未来需开展更大样本量的前瞻性随机对照研究，以明确mROM的复发率是否不劣于甚至优于WHO推荐的MDT方案，并为mROM更优的不良反应特征提供可靠数据支持。