盐酸安非他酮缓释片治疗抑郁症的随机、双盲、双模拟平行对照研究

Bupropion SR in treatment of major depression:a randomized, double blind, double dummy and controlled study

目的比较盐酸安非他酮缓释片与盐酸氟西汀治疗抑郁症的疗效和安全性。方法采用随机、双盲、双模拟、平行对照的方法,门诊抑郁症患者随机分为安非他酮组30例和氟西汀组30例,以盐酸安非他酮150mgbid,盐酸氟西汀20mgqd共治疗6周,以汉密尔顿抑郁量表(HAMD评定疗效,TESS评定安全性。结果安非他酮和氟西汀组的有效率分别为81.8%和85.7%,临床痊愈率分别为45.5%和67.9%,2组的差异无统计学意义;2组的不良事件发生率的差异无统计学意义。结论盐酸安非他酮缓释片是有效安全的抗抑郁药。

Objective： To compare the efficacy and safety of Bupropion SR versus fluoxetine in the treatment of major depression. Methods： Thirty depressive outpatients enrolled in bupropion SR group and 30 patients in fluoxetine group in a randomized, double blind, double dummy, and controlled study. The dose of Bupropion SR was 150mg, bid, and fluoxetine was 20mg, qd. The duration of treatment was 6 wk. HAMD was adopted to evaluate the efficacy, safety was evaluated by TESS. Results： The response rates of bupropion SR and fluoxetine group were 81.8% and 85.7%, respectively. The remission rate were 45.5% and 67.9%,respectively. There was no statistically difference between the two groups（ P 〉 0.05 ）. The rate of adverse event was no statistically difference between the two groups （P 〉 0.05 ）. Conclusion： Bupropion SR is an effective and safe antidepressant.