艾司西酞普兰与西酞普兰治疗抑郁症的随机、双盲、双模拟、多中心平行对照研究  

Escitalopram vs citalopram in treatment of depression:a randomized,double-blind,double-dummy,multicenter,parallel controlled study

作　　者：寻广磊[1] 李乐华[1] 赵靖平[1] 房茂胜[1] 张宏耕[2] 谢世平[3] 师建国[4] 杜波[5] 

机构地区：[1]中南大学湘雅二医院精神卫生研究所,湖南长沙410011 [2]湖南省脑科医院,湖南长沙410007 [3]南京脑科医院,江苏南京210029 [4]西安市精神卫生中心,陕西西安710061 [5]河北省精神卫生中心,河北保定071000

出　　处：《中国新药与临床杂志》2009年第4期263-267,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的评价国产艾司西酞普兰片治疗抑郁症的有效性和安全性。方法将240例单相抑郁症病人随机分为艾司西酞普兰组(120例)和西酞普兰组(120例),使用可变剂量进行为期6wk的双盲、双模拟对照研究,在治疗1、2、4、6wk末使用17项汉密尔顿抑郁量表(HAMD-17)、临床总体印象量表(CGI)进行疗效评价,使用不良事件记录表及相关实验室检查评价安全性。结果共计203例病人(艾司西酞普兰组101例,西酞普兰组102例)完成为期6wk治疗,2组的总体有效率分别为81.2%和83.3%,无显著差异(P=0.6891);但艾司西酞普兰组临床痊愈率(45.5%)高于西酞普兰组(29.4%),具有显著差异(P=0.0176)。2组不良反应总体发生率分别为28.7%和29.9%,无显著差异(P=0.8384),一般可以耐受。结论国产艾司西酞普兰片是一种安全有效的抗抑郁药物。AIM To evaluate the efficacy and safety of domestic manufactured escitalopram in treating unipolar depressioon. METHODS Two hundred and forty patients met with CCMD-3 criteria of depressive episode were randomized into escitalopram group （n = 120） and citalopram group （n = 120） for a six-week double-blind, double-dummy controlled study with flexible dosages for each respectively. The HAMD-17, CGI, adverse event rating scale and related laboratory examinations were employed to assess the effectiveness and safety of the treatment by the ends of 1, 2, 4, 6 wk. RESULTS Two hundred and three patients completed the study, 101 in escitalopram group and 102 in citalopram group; with total clinical effective rates of 81.2% and 83.3% respectively, and no significant difference between the two groups （P = 0.689 1） . The clinical curing rate was significantly higher in escitalopram group than that in citalopram group （45.5% vs 29.4%, P = 0.017 6）. The adverse reactions such as nausea and other gastrointestinal discomfort were well tolerated, with no significant difference in the prevalence between the two groups （28.7% vs 29.9%, P = 0.838 4）. CONCLUSION Domestic manufactured escitalopram is an effective and safe antidepressant.

关 键 词：抑郁症 西酞普兰 随机对照试验 双盲法 艾司西酥普兰 

分 类 号：R971.43[医药卫生—药品] R749.4[医药卫生—药学]