Clinical data on 29 patients with leprosy.

Introduction
The 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.
Objectives
To determine the clinical outcomes and experiences of individuals treated with mROM.
Methods
A 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.
Results
29 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.
Conclusions
In 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（WHO）推荐采用利福平、氨苯砜与氯法齐明组成的多药联合治疗（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、溶血性贫血与肝炎。英国伦敦热带病医院（HTD）将每月予利福平、氧氟沙星与米诺环素的联合疗法（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
本研究对在HTD接受mROM处方治疗的麻风病患者开展回顾性研究。研究收集了患者的人口学特征与临床数据，结局指标涵盖复发、麻风反应、细菌指数（Bacterial Index, BI）及不良反应；同时采用半结构化问卷对患者开展访谈，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例完成访谈。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方案，其中5例（55.6%）参与了本次访谈。经mROM治疗后，患者的细菌指数（BI）显著降低（p=0.04）。17例（58.6%）患者出现麻风反应。29例患者中仅1例（3.4%）出现复发，复发率为9.5例/1000人年。共报告49次不良反应，均为轻度或中度；其中最常见的不良反应为尿液橙染，共报告14次。无任何不良反应导致患者住院或终止mROM治疗。多数患者表示，完成mROM治疗时其皮肤病变已得到改善。

研究结论
本项在麻风病非流行地区开展的小型研究显示，mROM治疗安全、有效且可被患者接受。该疗法可改善皮肤病变、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似乎更优的不良反应特征提供可靠数据。