Richardus Jan H, Withington Stephen G, Anderson Alison M, Croft Richard P, Nicholls Peter G, Van Brakel Wim H, Smith W Cairns S
Department of Public Health, Erasmus MC, University Medical Center Rotterdam, PO Box 1738, 3000 DR Rotterdam, The Netherlands.
Lepr Rev. 2003 Dec;74(4):319-27.
Reactions in leprosy causing nerve function impairment (NFI) are increasingly treated with standardized regimens of corticosteroids, often under field conditions. Safety concerns led to an assessment of adverse events of corticosteroids, based on data of three trials studying prevention of NFI (the TRIPOD study). A multicentre, randomized, double-blind placebo-controlled trial was conducted in leprosy control programmes in Nepal and Bangladesh. Treatment was with prednisolone according to fixed schedules for 16 weeks, starting in one trial with 20 mg/day (prophylactic regimen: total dosage 1.96 g) and in the other two trials with 40 mg/day (therapeutic regimen: total dosage 2.52 g). Minor adverse events were defined as moon face, fungal infections, acne, and gastric pain requiring antacid. Major adverse events were defined as psychosis, peptic ulcer, glaucoma, cataract, diabetes and hypertension. Also, the occurrence of infected plantar, palmar, and corneal ulceration was monitored, together with occurrence of TB. Considering all three trials together, minor adverse events were observed in 130/815 patients (16%). Of these, 51/414 (12%) were in the placebo group and 79/401 (20%) in the prednisolone group. The relative risk for minor adverse events in the prednisolone group was 1.6 (P = 0.004). Adverse events with a significantly increased risk were acne, fungal infections and gastric pain. Major adverse events were observed in 15/815 patients (2%); 7/414 (2%) in the placebo group and 8/401 (2%) in the prednisolone group. No major adverse events had a significantly increased risk in the prednisolone arm of the trials. No cases of TB were observed in 300 patients who could be followed-up for 24 months. Standardized regimens of corticosteroids for both prophylaxis and treatment of reactions and NFI in leprosy under field conditions in developing countries are safe when a standard pre-treatment examination is performed, treatment for minor conditions can be carried out by field staff, referral for specialized medical care is possible, and sufficient follow-up is done during and after treatment.
在麻风病导致神经功能损害（NFI）的反应中，越来越多地采用标准化的皮质类固醇治疗方案，通常是在现场条件下进行。出于安全考虑，基于三项研究预防NFI的试验（TRIPOD研究）的数据，对皮质类固醇的不良事件进行了评估。在尼泊尔和孟加拉国的麻风病控制项目中开展了一项多中心、随机、双盲、安慰剂对照试验。根据固定疗程使用泼尼松龙治疗16周，在一项试验中起始剂量为20mg/天（预防方案：总剂量1.96g），在另外两项试验中起始剂量为40mg/天（治疗方案：总剂量2.52g）。轻微不良事件定义为满月脸、真菌感染、痤疮以及需要使用抗酸剂治疗的胃痛。严重不良事件定义为精神病、消化性溃疡、青光眼、白内障、糖尿病和高血压。此外，还监测了足底、手掌和角膜感染性溃疡的发生情况以及结核病的发生情况。综合三项试验来看，在130/815例患者（16%）中观察到轻微不良事件。其中，安慰剂组有51/414例（12%），泼尼松龙组有79/401例（20%）。泼尼松龙组发生轻微不良事件的相对风险为1.6（P = 0.004）。风险显著增加的不良事件为痤疮﹑真菌感染和胃痛。在15/815例患者（2%）中观察到严重不良事件；安慰剂组有7/414例（2%），泼尼松龙组有8/401例（2%）。在试验的泼尼松龙治疗组中，没有严重不良事件的风险显著增加。在300例可随访24个月的患者中未观察到结核病病例。在发展中国家的现场条件下，当进行标准的预处理检查、现场工作人员可对轻微病症进行治疗、能够转诊至专科医疗护理机构并在治疗期间和治疗后进行充分随访时，用于预防和治疗麻风病反应及NFI的标准化皮质类固醇治疗方案是安全的。
