艾司西酞普兰治疗抑郁症的随机双盲对照试验

目的比较艾司西酞普兰和西酞普兰治疗抑郁症的疗效和安全性。方法本研究为6周的多中心、随机、双盲双模拟、平行阳性对照试验。共入组240例符合中国精神障碍分类与诊断标准第3版的抑郁症诊断标准的患者,其中试验组（艾司西酞普兰）120例和对照组（西酞普兰）120例。试验组剂量为10～20mg/d,对照组剂量为20～40mg/d,评估量表为17项汉密尔顿抑郁量表（HAMD-17）,汉密尔顿焦虑量表（HAMA）以及临床总体印象量表（CGI）。安全性评估包括评估不良事件、体检、实验室检查和心电图检查等。结果 212例患者完成了研究,试验组108例,对照组104例。全分析集（FAS）结果显示：治疗6周后,试验组的HAMD减分为（15.4±7.1）分,对照组为（14.5±7.1）分;试验组的有效率为78.3%,临床痊愈率为57.5%,对照组分别为73.3%、52.5%;两组差异无统计学意义。两组治疗后HAMA评分均下降,组间差异无统计学意义。两组在各访视点CGI严重程度评分差异皆无统计学意义。治疗第2周时,试验组的有效率高于对照组（分别为22.5%,10.8%,χ^2=5.88,P=0.02）,临床痊愈率也高于对照组（分别为11.7%,2.5%,χ^2=7.66,P〈0.01）。试验组中有39例（32.5%）发生不良反应,对照组中有37例（30.8%）发生不良反应,两组差异无统计学意义。试验组常见的不良反应为恶心（12.5%）、口干（10.0%）、头晕（9.2%）,对照组为恶心（14.2%）、口干（7.5%）。结论艾司西酞普兰治疗抑郁与西酞普兰的疗效相当,耐受性好,起效可能更快。

Randomized double-blind controlled trial of escitalopram versus citalopram in the treatment of depression

Objective：Compare the efficacy and safety of escitalopram and citalopram in patients with depression.Methods：This multicenter,randomized,double-blind,double-dummy study enrolled 240 patients who met the Chinese Classification of Mental Disorders（CCMD-3）criteria for depression and randomly assigned them to 6 weeks of treatment with 10-20 mg/d escitalopram（n=120）or 20-40 mg/d citalopram（n=120）.Efficacy was assessed with the Hamilton rating scale for depression（HAMD-17）,the Hamilton rating scale for anxiety（HAMA）and the Clinical Global Impression scale（CGI）.Monitoring for adverse events was based on the results of laboratory tests,electrocardiograms,and regular assessments of vital signs.Results：At the end of the study 108 patients remained in the escitalopram group and 104 in the citalopram group.Using the Full Analysis Set method（i.e.,only considering subjects who took at least one dose of the medication）the mean（sd）change in the total HAMD score at 6 weeks in the escitalopram and citalopram groups were not significantly different 15.4（7.1）and 14.5（7.1）,P〈0.05];and the proportions who met criteria for response（78.3% versus 73.3%,respectively）,and the proportions who met criteria for remission（57.5% versus 52.5%,respectively）were not significantly different.The results for the HAMA and CGI also found no significant differences between the groups.However,at the end of the second week the response rate was higher in the escitalopram group（22.5% versus 10.8%,P=0.02）and the remission rate was also higher in the escitalopram group（11.7% versus 2.5%,P〈0.01）.The rates of occurrence of adverse events in the escitalopram group（n=39,32.5%）and citalopram group（n=37,30.8%）were not significantly different（P=0.60）.Nausea（12.50%）,dry mouth（10.0%）and dizziness（9.2%）were the most frequently reported adverse events in the escitalopram group;and nausea（14.2%）and dry mouth（7.5%）were the most frequently reported in the citalopram group.Conclusion：Escitalopram is as effective as and as safe as citalopram in patients with depression;it may have a more rapid onset of action.