盐酸安非他酮缓释片治疗抑郁症的双盲双模拟随机对照试验

Double-blind, Double-dummy, Randomized Controlled Trials of Bupropion Hydrochloride Sustained-release Tablets for Depression

目的 评价盐酸安非他酮缓释片治疗抑郁症的疗效和安全性。方法 采用随机双盲双模拟方法，将符合CCMD-3有关单相抑郁发作和双相情感障碍抑郁发作标准的患者48例，随机分为安非他酮组和氟西汀组。两组患者于清洗3～7天后分别给予盐酸安非他酮缓释片300mg／d和氟西汀片20mg／d，疗程均为42天。临床疗效观察采用汉密尔顿抑郁量表（HAMD）评分、汉密尔顿焦虑量表（HAMA）评分、临床总体印象量表（CGI）评分和治疗药物副作用量表（TESS），实验室检查包括血常规、小便常规、生化和心电图。结果 两组基线与治疗各。阶段HAMD量表、HAMA量表评分的变化情况显示：安非他酮组治疗有效率83．3％（20/24），氟西汀组为62．5％（15／24）两组不良反应率均为45．9％（11／24），未见严重不良反应。结论 安非他酮和氟西汀组疗效相当，能有效治疗抑郁症及伴随焦虑症状，不良反应轻微。

Objective To evaluate the therapeutic effect and safety of Bupropion hydrochloride sustained-release tablets in the treatment of depression. Methods A total of 48 patients meeting the diagnostic criteria of depression of CCMD-3 were randomly treated withBupropion hydrochloride sustained-release tablets or Fluoxetine tablets for 42 days. Hamilton depression rating scale, Hamilton anxiety rating scale, clinical global impression and treatment emergent symptom scale were used to evaluate the therapeutic effect. Blood routine test, urine routine test and electrocardiogram were examined before and after the treatment. Results The effective rate of Bupropion hydrochloride sustained-release tablets [83% （20/ 24） ] was higher than that of Fluoxetine tablets [63% （15/24）], with a P value of 0.104. The incidence of adverse reactions was 46% （11/24） in both groups. Conclusion The therapeutic effect of Bupropion hydrochloride sustained-release tablets on depression is similar to that of Fluoxetine tablets, with mild adverse reactions to bothtreatments.