Sivakumaran Priyanka, Barros Barbara de, Antonio Dias Vivianne Lopes, Lockwood Diana N, Walker Stephen L
Royal London Hospital, London, United Kingdom.
Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
PLoS Negl Trop Dis. 2024 Dec 9;18(12):e0012699. doi: 10.1371/journal.pntd.0012699. eCollection 2024 Dec.
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.
To determine the clinical outcomes and experiences of individuals treated with mROM.
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.
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.
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.
世界卫生组织(WHO)推荐使用利福平、氨苯砜和氯法齐明联合化疗(MDT)治疗麻风病。严重不良反应包括氨苯砜超敏综合征、皮肤色素沉着、溶血性贫血和肝炎。在英国伦敦热带病医院(HTD),每月使用利福平、氧氟沙星和米诺环素(mROM)作为麻风病的一线治疗方案。
确定接受mROM治疗的患者的临床结局和治疗体验。
对在HTD接受mROM治疗的麻风病患者进行回顾性研究。收集人口统计学和临床数据,包括复发情况、麻风反应、细菌指数(BI)和不良反应。使用半结构化问卷对患者进行访谈,以了解他们对mROM的治疗体验。
共确定了29例患者,其中20例接受了访谈。26例(89.7%)患者完成了每月的mROM治疗。9例(31%)患者从WHO的MDT方案转换为mROM方案(其中5例(55.6%)接受了访谈)。mROM治疗后BI显著降低(p = 0.04)。17例患者(58.6%)出现了麻风反应。29例中有1例(3.4%)复发。复发率为9.5/1000人年。共报告了49例轻度或中度不良反应。最常见的不良反应(14/49)是尿液橙色变色。没有不良反应需要住院治疗或停用mROM。大多数患者报告说,在完成mROM治疗时皮肤病变有所改善。
在这个非麻风病流行地区的小型研究中,mROM安全、有效且可接受。mROM治疗与皮肤病变改善、细菌指数下降以及可接受的不良反应相关。需要进行更大规模的前瞻性随机研究,以确定mROM的复发率是否与WHO的MDT相当或更好,并提供关于mROM似乎更好的不良反应情况的有力数据。