安非他酮缓释片治疗抑郁伴随焦虑症状的随机双盲临床研究  

Bupropion SR in the treatment of depression comorbid with anxiety:a randomized,double-blind clinical trial

作　　者：吴彦[1,2] 沈一峰[1,2] 李华芳[1] 孙学礼[3] 许秀峰[4] 高成阁[5] 顾牛范 

机构地区：[1]上海交通大学医学院附属精神卫生中心,200030 [2]复旦大学附属华山医院 [3]四川大学华西医院 [4]昆明医学院附属第一医院 [5]西安交通大学第一医院

出　　处：《上海精神医学》2009年第5期285-288,共4页Shanghai Archives of Psychiatry

摘　　要：目的评价安非他酮缓释片治疗抑郁伴随焦虑的疗效和安全性。方法采用随机、双盲双模拟、多中心、氟西汀平行对照的研究方法,为期6周,共入组汉密尔顿抑郁量表17项评分(HAMD17)≥18且汉密尔顿焦虑量表(HAMA)评分≥14的抑郁伴焦虑患者169例,完成146例,其中安非他酮组79例,氟西汀组67例。剂量分别为安非他酮缓释片300mg/d、氟西汀20mg/d治疗。结果治疗6周后,安非他酮组和氟西汀组的HAMA总分减分值分别为11.8±7.5与11.6±5.8,与治疗前相比差异均有统计学意义,但两组之间相比差异无统计学意义(P>0.05)。2组的不良反应发生率分别为47.19%和42.31%,差异无统计学意义。结论安非他酮缓释片治疗抑郁伴随的焦虑症状有效。Objective： To evaluate efficacy and safety of bupmpion SR in the treatment of depression comorbid with anxiety. Methods： This 6- week, randomized, double- blind, double-dummy, parallel controlled, multi-center clinical trial compared the efficacy and safety measures of bupropion SR to those of fluoxetine in patients of depression comorbid with anxiety symptoms. One hundred sixty - nine patients with HAMD17≥18 and HAMA ≥14 were enrolled in this clinical trial, 146 patients completed the period of treatment. Among these, 79 patients received bupropion SR 300 mg/d （study group） and 67 patients received fluoxetine 20 mg/d （control group）. Results：The mean change of HAMA total score from baseline to week 6 was （11.8±7.5） in study group and （11.6±5.8） in control group and the difference between baseline and week 6 was statistically significant in both groups. However, there was no significant difference between the two groups （P 〉0.05）. Patients reporting adverse reactions during the clinical trial were 47.19% in study group and 42.31% in control group and the difference between the two groups was not statistically significant. Conclusion ： Bupropion SR is an effective antidepressant in the treatment of depression comorbid with anxiety.

关 键 词：安非他酮 抑郁伴发焦虑 氟西汀 疗效 安全性 随机 双盲 

分 类 号：R749.4[医药卫生—神经病学与精神病学]