度洛西汀与帕罗西汀治疗抑郁症的多中心双盲对照研究

Duloxetine versus paroxetine in the treatment of major depressive disorder:a randomized double-blind multicentre controlled study

目的:以帕罗西汀为对照,评价度洛西汀治疗抑郁症的疗效和安全性。方法:采用随机双盲多中心对照研究方法,244例患者纳入研究,度洛西汀组121例(60 mg.d-1),帕罗西汀组123例(20 mg.d-1),疗程8周。以汉密尔顿抑郁评定量表17项作为主要疗效评价指标。结果:度洛西汀组与帕罗西汀组的有效率分别为71.1%和71.5%(P>0.05)。度洛西汀的不良事件发生率(75.0%)高于帕罗西汀组(62.3%),差异有统计学意义(P=0.0381)。结论:度洛西汀治疗抑郁症的疗效与帕罗西汀相当,个别不良事件发生率度洛西汀高于帕罗西汀。

Objective： To evaluate the efficacy and safety of duloxetine in comparison with paroxetine in patients who met Diagnostic and Statistical Manual fourth edition（DSM-IV） criteria of major depressive disorder.Methods： A randomized,double-blind,controlled multicentre clinical trial was conducted.All subjects（n=244） were treated with either duloxetine 60 mg·d-1（n=121） or paroxetine 20 mg·d-1（n=123） for 8 weeks.The main efficacy measure was the change in total score of the Hamilton Depression Scale 17 item（HAMD17） from baseline to endpoint.Results： The response rates were 71.1%（duloxetine） and 71.5%（paroxetine）.There were no significant differences between 2 groups.The efficacy of duloxetine was non-inferiority of paroxetine＇s in treatment of MDD.There were significantly higher adverse events in the duloxetine group（75.0%） than in the paroxetine group（62.3%,P=0.038 1）.Conclusion： Duloxetine and paroxetine have similar therapeutic effect in treatment of patients with major depressive disorder,but duloxetine causes more adverse events.