艾司西酞普兰治疗老年慢性心力衰竭并抑郁障碍的近期疗效和安全性随机对照研究  

Randomized Controlled Study on Short-Term Efficacy and Safety of Escitalopram in Treating Senile Chronic Heart Failure Complicating Major Depression

作　　者：贾璐[1] 徐凌 杨容[1] 

机构地区：[1]重庆市第九人民医院心理卫生科,重庆400700 [2]重庆医药集团股份有限公司,重庆400010

出　　处：《中国药业》2012年第6期23-25,共3页China Pharmaceuticals

摘　　要：目的研究艾司西酞普兰治疗老年慢性心力衰竭合并抑郁障碍的疗效和安全性。方法采用随机对照、开放性设计,将98例在三甲综合医院接受门诊和住院治疗的患者随机分为两组,艾司西酞普兰组49例,舍曲林组49例,疗程8周。用汉密尔顿抑郁量表(HAMD-17)评估抗抑郁疗效,用副反应量表(TESS)评估患者的药物不良反应。结果艾司西酞普兰组治疗期间脱落率与舍曲林组比较,差异无统计学意义(18.36%比22.45%,P=0.616);起效时间早于舍曲林组,HAMD评分在第2周末(F=7.311,P=0.008)、第4周末(F=4.646,P=0.034)低于舍曲林组,但到第6周末(F=0.899,P=0.345)和第8周末(F=1.320,P=0.253)两组差异无统计学意义。第8周末时,艾司西酞普兰组痊愈12例(24.49%),显著进步22例(44.90%),进步3例(6.12%),无效12例(24.49%);舍曲林组痊愈10例(20.41%),显著进步23例(46.94%),进步2例(4.08%),无效14例(28.57%)。两组痊愈率(χ2=0.23,P=0.63)和显效率(x2=0.21,P=0.65)差异无统计学意义,不良反应发生率亦无统计学差异(26.53%比38.78%,P=0.396)。两种抗抑郁药物对左心室射血分数(LVEF)的改善无统计学差异(F=1.405,P=0.239)。心电图校正的QT间期(QTc)在两组患者治疗前后(F=0.069,P=0.793)和两组间(F=0.319,P=0.574)均无统计学差异。结论艾司西酞普兰治疗老年慢性心力衰竭合并抑郁障碍的疗效和安全性与舍曲林相当,但起效更快。Objective To evaluate the efficacy and safety of eseitalopram in the patients with elderly chronic heart failure complicating major depression. Methods By randomized controlled open-label study, 98 outpatients and inpatients in a Third Grade Class A hospital were randomly assigned to the eseitalopram group （n =49） and the sertraline group （n =49） for 8- week treatment. The anti- depression efficacy was evaluated with the Hamilton Depression Scale （HAMD- 17）. The Treatment Emergent Symptom Scale （TESS） was used to evaluate the adverse reactions. Results The drop rate of the escitalopram group was not statistically different from the sertraline group （18.36% vs. 22.45%, P=0. 616）. The escitalopram group showed earlier depressive symptoms improvement than the sertraline group. At the end of 2 weeks （F=7.311, P=0.008） and at the end of 4 weeks （F=4.646, P=0.034）,HAMD scores of the escitalopram group were lower than those of the sertraline group. But at the end of 6 weeks （F=0. 899, P=0. 345） and the end of 8 weeks （F= 1. 320, P=0. 253）, HAMD scores had no statistically difference between the two groups. At the end of 8 weeks, there were 12 cured cases（24.49% ）, 22 significant improvement eases（44.90% ）, 3 progress cases（6. 12% ） and 12 invalid cases（24.49% ） in the escitalopram group, while there were 10 cured eases（20. 41% ）, 23 significant improvement cases（46.94% ）, progress eases（4.08% ） and 14 invalid cases（28.57% ） in the sertraline group, showing no statistical difference between the two groups （χ2 =0.23. P=0. 63）.There was no statistical difference in the rates of adverse reactions between the two groups（26.53% vs. 38.78%, P=0. 396）. The difference of the improvements of cardiac function had no statistical significance between the two groups （F = 1. 405, P =0. 239）. Before and after treatment, the difference of ECG corrected QT interval （QTe） were not statistically significant different in two groups （F=0.069, P= 0. 793）.

关 键 词：心力衰竭 抑郁 艾司西酞普兰 舍曲林 随机对照研究 

分 类 号：R749.405.3[医药卫生—神经病学与精神病学] R971.43[医药卫生—临床医学]