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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 evaluate the efficacy and safety of brivudine 125 mg once daily and 4 times daily for the treatment of shingles. Methods Multicenter, randomized, double-blind, parallel-controlled clinical trial. A total of 226 patients with herpes zoster received brivudine 125 mg once daily (n = 112) or 4 times daily (n = 114) for 7 days and followed up for 3 weeks. Results new blisters stopped appearing time, the average single dose group was 3.88d, 4 dose group was 3.79d, the two groups, the difference was not statistically significant. There was no significant difference between the two groups when the blisters completely subsided, the time of initial scab, the time of total scab, the time of initial scab, the time of total scab, the time of relieving pain and the complete disappearance of pain. 34.5% in single-dose group and 30.4% in 4-dose group still had herpes-related pain after healed. The incidence of drug-related adverse events were 5.4% and 9.6%, respectively. Conclusion Brivudine 125mg once daily and 4 times a day are equally effective in the treatment of herpes zoster, but the single dose group is more convenient and safe.