艾司西酞普兰与舍曲林治疗门诊抑郁症的对照研究

Comparison of efficacy and safety between escitalopram and sertraline in the treatment of depressive outpatients

目的探讨艾司西酞普兰对门诊抑郁症病人的疗效和安全性。方法68例符合CCMD-3抑郁发作的门诊病人随机分为艾司西酞普兰组和舍曲林组,艾司西酞普兰剂量10～20mg/d,舍曲林50～200mg/d,疗效采用汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)评定,不良反应和安全性用TESS和实验室检查评定。观察时间为期6周。结果艾司西酞普兰组有效率70.6%,治愈率47.1%,舍曲林组有效率61.8%,治愈率41.2%,两组比较差异无显著性。艾司西酞普兰主要不良反应为食欲下降(11.8%)、恶心(8.8%)、头晕(8.8%)、口干(5.9%)等,与舍曲林无差异。脱落率和失访率各为11.8%和14.7%,无显著差异。结论艾司西酞普兰治疗门诊抑郁症病人安全有效,疗效和不良反应与舍曲林相似。

Objective： To study the efficacy and safety of escitalopram in the treatment of depressive outpatients. Methods： This was a randomized, open -label, 6 weeks flexible dose study. 68 outpatients diagnosed as depression based on CCMD - 3 criteria were randomly assigned to eseitalopram treatment group with escitalopram 10 - 20mg per day （ n = 34 ） or sertraline treatment group with sertraline 50 - 200mg per day （ n = 34）. Clinical effectiveness was evaluated using HAMD and HAMA, and adverse reactions and safety were assessed with TESS and laboratory examination. Results：The mean values of HAMD and HAMA total scores improved for both groups from the baseline to week 6, with no statistically significant difference between two groups. The response rate and remission rate were 70.6% and 47.1% for eseitalopram group and were 61.8% and 41.2% for sertraline group respectively, without statistically significant difference between two groups for both rates. The main adverse reactions were lack of appetite, nausea, dizziness, and dry mouth for both groups. Four patients in escitalopram group and five patients in sertraline group dropped out because of the adverse reactions. Conclusion： Escitalopram （10 - 20mg/day） demonstrated as effectively and tolerably as sertraline over 6 weeks treatment of depressive outpatients.