安非他酮治疗抑郁症的随机双盲平行对照的多中心临床试验.DOCVIP

国产安非他酮缓释片治疗抑郁症的II期临床研究( 姜荣环1， 张鸿燕1，舒 良1 ，杜 波2，李华芳3，殷美丽3，朱海兵4，刘忠纯5 （1 北京大学第六医院，北京 100083；2 河北省第六人民医院,保定 071000；3 上海市精神卫生中心, 上海 200030；4 广州市脑科医院，广州 510370；5 武汉大学人民医院, 武汉 430060） [摘要] 目的：评价安非他酮治疗抑郁症的疗效和安全性。方法：采用随机、双盲、多中心、平行对照研究。共入组抑郁症患者237例，其中试验组119例，对照组118例，分别口服安非他酮150～450mg·d-1，氟西汀10～30mg·d-1。疗程均为6周。用汉密尔顿抑郁量表（HAMD）和临床总体印象量表（CGI）评定疗效，药物不良反应量表（TESS）评定安全性。结果：治疗6周后两组患者HAMD 评分较基线均显著降低（P0.05），总有效率安非他酮组70.69%，氟西汀组74.14%，组间差异无显著性（P0.05）。不良反应发生率安非他酮组41.4%，氟西汀组44.8%，组间差异无显著性（P0.05）。结论：安非他酮治疗抑郁症安全有效。 [关键词] 安非他酮；氟西汀；抑郁症 [中图分类号] Ｒ971.4;R969.4 文献标识码］A 文章编号］1003-3734 A phase II clinical trial of Bupropion SR for treatment of depressive disorders JIANG Rong-huan1, ZHANG Hong-yan1, SHU Liang1, DU Bo2, LI Hua-fang3, YIN Mei-ru3, ZHU Hai-bin4, LIU Zhong-chun5 (1 Institute of Mental Health, Peking University, Beijing 100083, China; 2 The Sixth Hospital of Hebei Province, Baoding 071000, China; 3 Shanghai Mental Health Center, Shanghai 200030, China；4 Guangzhou Brain Hospital, Guangzhou 510370, China；5 People’s Hospital of Wuhan University, Wuhan 430060, China) [Abstract] Objective: To evaluate the efficacy and safety of bupropion for the treatment of depressive disorders. Methods: 237 patients with depressive disorders were enrolled in a randomized, double blind, multi-center, parallel controlled study. The patients were randomized to orally receive either bupropion 150～450mg daily (n=119) or fluoxetine 10～30mg daily (n=118) for 6 weeks. Hamilton Depression Rating Scale and Clinical Global Impression were used to evaluate the efficacy. The Treatment Emergent Symptom Scale were used to assess the safety. Results: Both groups’ endpoint HAMD scores and CGI scores reduced significantly in comparison with the baseline（P0.05）.The response rate of bupropion and fluoxetine were 70.69% and 74.14%, respectively（P0.05）. There was no significant difference between two groups. The adverse reaction rate of bupropion and fluoxetine were 41.4% and 44.8 %, respectively（P0.05）. Conclusion: Bupropion i