Siagian Joyce Novelyn, Menaldi Sri Linuwih
Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.
Department of Dermatology and Venereology, Faculty of Medicine, University of Indonesia and Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
SAGE Open Med. 2022 Apr 19;10:20503121221089448. doi: 10.1177/20503121221089448. eCollection 2022.
Main therapy for leprosy reactions is 12 weeks corticosteroids according to World Health Organization recommendations, but recovery cannot be achieved and recurrence occurs. Long duration of administration was thought to provide better clinical improvement. Evidence of the efficacy of corticosteroids in leprosy reactions is still lacking, and optimal dose and duration of therapy vary, while the need for long-term high-dose corticosteroids makes it difficult to avoid adverse effects.
This is a retrospective cohort study analyzing the difference between therapeutic effectiveness and adverse effects of 12 weeks and >12 weeks corticosteroids, involving all new leprosy patients without age restriction, at Cipto Mangunkusumo Hospital and Cakung Community Health Center in Indonesia during 1 January 2015-31 December 2017. Secondary data were collected from medical records, and observations carried out until December 2018. Therapeutic effectiveness was assessed from clinical improvement to corticosteroids discontinuation, without 3 months recurrence after first cycle was completed. Adverse effects were assessed by all corticosteroids-related side effects.
Of 195 patients, 57 (29.2%) used 12 weeks corticosteroids, and 138 (70.8%) for >12 weeks. Effectiveness occurred in 38 (66.7%) of 12 weeks group and 106 (76.8%) of >12 weeks group (relative risk = 0.604, 95% confidence interval = 0.307-1.189, p = 0.143). Of 145 patients, adverse effects occurred in 12 (31.6%) of 12 weeks group and 70 (65.4%) of >12 weeks group (relative risk = 0.244, 95% confidence interval = 0.111-0.538, p < 0.001). Of 171 adverse effects, 37.4% were mild such as dyspepsia, skin disorders, and lipodystrophy, while 62.6% were severe in the form of neuropsychiatric disorders, eye disorders, cardiovascular disease, gastrointestinal bleeding, metabolic-hormonal abnormalities, and reactivation of infections.
There is no effectiveness difference in the form of clinical improvement without 3 months recurrence, between 12 weeks and >12 weeks corticosteroid, while longer administration causes 4 times more events.
根据世界卫生组织的建议，麻风反应的主要治疗方法是使用12周的皮质类固醇，但无法实现康复且会复发。人们认为延长给药时间能带来更好的临床改善。目前仍缺乏皮质类固醇治疗麻风反应有效性的证据，治疗的最佳剂量和疗程各不相同，而长期使用高剂量皮质类固醇难以避免不良反应。
这是一项回顾性队列研究，分析了12周和超过12周皮质类固醇治疗效果和不良反应的差异，研究对象为2015年1月1日至2017年12月31日期间印度尼西亚西托·曼古库苏莫医院和贾孔社区卫生中心所有无年龄限制的新麻风病患者。从病历中收集二手数据，并持续观察至2018年12月。治疗效果通过从临床改善到停用皮质类固醇来评估，在第一个周期完成后3个月内无复发。不良反应通过所有与皮质类固醇相关的副作用来评估。
195例患者中，57例（29.2%）使用12周皮质类固醇，138例（70.8%）使用超过12周皮质类固醇。12周组38例（66.7%）有效，超过12周组106例（76.8%）有效（相对风险=0.604，95%置信区间=0.307-1.189，p=0.143）。145例患者中，12周组12例（31.6%）出现不良反应，超过12周组70例（65.4%）出现不良反应（相对风险=0.244，95%置信区间=0.111-0.538，p<0.001）。在171例不良反应中，37.4%为轻度，如消化不良、皮肤疾病和脂肪代谢障碍，而62.6%为重度，表现为神经精神疾病、眼部疾病、心血管疾病、胃肠道出血、代谢-激素异常和感染复发。
在3个月内无复发的临床改善形式方面,12周和超过12周的皮质类固醇治疗效果没有差异，但延长给药时间会使不良反应事件增加4倍。
