阿戈美拉汀治疗抑郁症急性期疗效的系统评价

Systematic Review of the Efficacy of Agomelatine in the Treatment of Depression in Acute Phase

目的:系统评价阿戈美拉汀治疗抑郁症急性期的疗效,以为临床治疗提供循证参考。方法:计算机检索Cochrane图书馆、Medline、EMBase、中国期刊全文数据库、中文科技期刊数据库、中国生物医学数据库、万方数据库以及世界卫生组织(WHO)临床试验注册平台和美国临床试验注册平台,收集阿戈美拉汀对比安慰剂治疗抑郁症急性期的随机对照试验(RCT),对符合纳入标准的临床研究进行质量评价和资料提取后,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入7项RCT,合计2 378例患者。Meta分析结果显示,阿戈美拉汀组患者有效率[RR=1.43,95%CI(1.29,1.59),P<0.001]、缓解率[RR=1.27,95%CI(1.03,1.57),P=0.02]均显著高于安慰剂组,抑郁量表终点评分值显著低于安慰剂组[MD=-2.92,95%C(I-3.65,-2.20),P<0.001],两组比较差异均有统计学意义。结论:阿戈美拉汀治疗抑郁症急性期的疗效显著。但受纳入研究方法学质量和样本量限制,该结论有待更多设计严格、长期随访的大样本RCT加以验证。

OBJECTIVE：To systematically review the efficacy of agomelatine in the treatment of depression in acute phase, and provide evidence-based reference for the clinical treatment. METHODS： Retrieved from Cochrane Library, Medline, EMBase, CJFD, VIP, CBM, Wanfang Database, WHO Clinical Trials Registry Platform and American Clinical Trials Registry Platform, the randomized controlled trials （RCT） about agomelatine versus placebo in the depression patients in acute phase. After quality evaluation and data extraction, Meta-analysis was conducted by using Rev Man 5.2 statistics software. RESULTS： A total of 7 RCT were included, involving 2 378 patients. Results of Meta-analysis showed the effective rate in agomelatine group was obviously bet- ter than placebo group [RR = 1.43,95 % CI （ 1.29,1.59 ）, P〈 0.001], remission rate was obviously better than placebo group [RR = 1.27,95 % CI （ 1.03,1.57 ）, P = 0.02], and the endpoint score of depression scales was obviously lower than placebo group [MD = - 2.92,95 % CI （ -- 3.65, -- 2.20）, P〈0.001], there was statistically significance. CONCLUSIONS： Agomelatine is effective in the treatment of depression patients in acute phase. However, due to the limit of methodological quality and sample size, it remains to be further verified with more rigorously designed and long-term follow-up of large-scale RCT.