溴夫定治疗带状疱疹的疗效和安全性评价

Evaluation of efficacy and safety of brivudine once daily versus 4 times daily in the treatment of herpes zoster

目的评价溴夫定125 mg每天1次和每天4次治疗带状疱疹的疗效和安全性。方法多中心、随机、双盲、平行对照临床试验。226例带状疱疹患者分别接受溴夫定125mg每天1次(112例)或每天4次(114例)治疗,疗程7d,再随访3周。结果新水疱停止出现时间,单次剂量组平均为3.88d,4次剂量组为3.79d,两组比较,差异无统计学意义。水疱完全消退时间、开始结痂时间、全部结痂时间、开始脱痂时间、全部脱痂时间、疼痛开始减轻时间和疼痛完全消失时间两组比较,差异均无统计学意义。单次剂量组有34.5%、4次剂量组有30.4%的患者皮损痊愈后仍存在疱疹相关疼痛。药物相关不良反应发生率分别为5.4%和9.6%。结论溴夫定125mg每天1次和每天4次治疗带状疱疹同样有效,但单次剂量组更方便、安全。

Objective To assess efficacy and safety of oral brivudine 125 mg once daily versus 4 times daily in the treatment of herpes zoster. Methods A five-centre, randomized, double-blind, parallelcontrolled study was performed on 226 patients with herpes zoster. Oral brivudine 125 mg was given once daily to 112 patients, and four times daily to 114 patients, both for 7 days. All patients were followed up for 3 weeks after the end of treatment. Results The time to the last formation of new vesicles was 3.88 days for the once daily group, and 3.79 days for the 4 times daily group, without significant differences between the two groups. There was also no significant difference between the two groups with respect to the time to total resolution of vesicles, time to first crusts, time to full crusting, time to first loss of crusts, time to full loss of crusts, time to first relief of pain, and time to complete relief of pain. Postherpetic neuralgia occurred in 34.5% of patients in the once daily group, and 30.4% of patients in the 4 times daily group. The incidence of treatment-related adverse events was 5.4% and 9.6%, in the once daily group and 4 times daily group, respectively. Conelusious Brivudine 125 mg once daily is equally effective, more convenient and safe in comparison with brivudine 125 mg 4 times daily for the treatment of herpes zoster.