度洛西汀肠溶片治疗抑郁症多中心随机双盲对照临床研究  

A multi-center,randomized,and double-blind controlled clinical trial of duloxetine enteric-coated tablets in treatment of depression

作　　者：解魏卫[1] 赵靖平[1] 伍海姗[1] 张宏耕[2] 谢世平[3] 张波[4] 郑洪波[5] 李乐华[1] 

机构地区：[1]中南大学湘雅二医院精神卫生研究所,湖南长沙410011 [2]湖南省脑科医院,湖南长沙410007 [3]南京医科大学脑科医院,江苏南京210029 [4]四川大学华西医院,四川成都610041 [5]广州市脑科医院,广东广州510370

出　　处：《中国新药与临床杂志》2013年第8期632-636,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的评价国产度洛西汀肠溶片治疗抑郁症的疗效和安全性。方法采用随机双盲双模拟多中心阳性药平行对照临床研究。两组分别口服度洛西汀60 mg·d^(-1)、帕罗西汀20 mg·d^(-1),疗程为6周。在基线和治疗1、2、4、6周末以汉密尔顿抑郁量表17项(HAMD-17)进行疗效评价,以不良事件、实验室检查和心电图检查等评价安全性。结果共入组269例抑郁症患者,全分析数据集(FAS)和安全性数据集(SS)均为257例,度洛西汀组128例、帕罗西汀组129例。两组经6周治疗后HAMD-17评分呈减分趋势,各时点评分与基线比较均有显著差异(P<0.01);治疗后两组间各时点HAMD-17评分、减分值及减分率比较无显著差异(P>0.05)。度洛西汀组与帕罗西汀组有效率分别为71.1%和78.3%,临床治愈率分别为50.8%和59.7%,组间无显著差异(P>0.05);药物治疗中不良事件发生率分别为36.7%、34.9%,组间无显著差异(P>0.05)。结论国产度洛西汀肠溶片治疗抑郁症安全、有效。AIM To evaluate the efficacy and safety of domestic duloxetine enteric-coated tablets in the treatment of depression. METHODS A randomized, double- blinded, double- dummy, paroxetine- controlled, muhicentre clinical trial was conducted. In the six-week triM, two groups were treated with duloxetine 60 mg·d^-1 or paroxetine 20 mg·d^-1, respectively. The clinical efficacy was evaluated by the score changes of 17-Items Hamilton Depression Rating Scale （HAMD- 17） after 0, 1, 2, 4, 6 weeks of the treatment, and the safety was estimated by the reports of adverse events and the results of laboratory and electrocardiogram examination. RESULTS Totally 269 patients with depression were enrolled. There were 257 patients in Full Analysis Set and Safety Set respectively, 129 patients in the paroxetine group and 128 patients in the duloxetine group. During the six-week treatment, the HAMD-17 scores in both groups had significant reduction in comparison with the baseline （P 〈 0.01 ） , while there were no significant differences between the two groups in HAMD- 17 total scores, reduce scores and reduce rate （P 〉 0.05）. The effective rate was 71.1% in the duloxetine group and 78.3% in the paroxetine group （P 〉 0.05）, the remission rate was 50.8% and 59.7% respectively （P 〉 0.05）, and the incidence rate of adverse events was 36.7% and 34.9% respectively （P 〉 0.05） , with no significant differences between the two groups. CONCLUSION Domestic duloxetine enteric- coated tablets is safe and effective in treatment of depression.

关 键 词：度洛西汀 帕罗西汀 抑郁症 多中心研究 随机对照试验 

分 类 号：R971.4[医药卫生—药品]