艾司西酞普兰与氟西汀治疗老年期抑郁症对照研究

A comparative study on treatment of elderly depression with Escitaiopram and Fluoxetine

目的观察艾司西酞普兰治疗老年期抑郁症的疗效和安全性。方法采用随机对照、开放标签设计，103例老年抑郁症患者随机分到艾司西酞普兰治疗组和氟西汀治疗组，治疗8周。汉密尔顿抑郁量表（HAMD）和汉密尔顿焦虑量表（HAMA）评估患者疗效，意向治疗分析法（Intent to Treat Analysis，ITT）处理研究数据。对中途退出或失访的病例按照末次观察推进法（Last Observation Carried Forward，LOCF）处理缺失值。结果治疗8周脱落率艾司西酞普兰组低于氟西汀组，差异有统计学显著性（21％：41％，χ^2=4．82，P〈0．028）；完成8周疗效观察的病例，艾司西酞普兰组有效率为90．3％；氟西汀组有效率86．6％，两组差异无统计学差异（χ^2=1．282，P=0．673）；ITT分析显示两组8周时疗效显著性差异，艾司西酞普兰治疗组抑郁和焦虑症状评分改善的时间早于氟西汀组，且不良反应率低于氟西汀组。结论艾司西酞普兰治疗老年抑郁症患者疗效和耐受性均优于氟西汀。

Objective To evaluate the efficacy and safety of escitalopram in treatment of elderly patients with major depression. Methods Using randomized control and open-- label study, 103 elderly patients with depression were randomly assigned to either eseitalopram or fluoxetine group, and treated for 8 weeks. Primary outcome was measured by scores of HAMD （Hamilton Depression Scale） and HAMA （Hamilton Anxiety Scale）. ITT （Intent to Treat Analysis） was used to process data and LOCF （Last Observation Carried Forward） was adopted to deal with missing value caused by withdrawing patients during 8--week observation. Results 8--weeks drop off rate of escitalopram group was lower than that of fluoxetine group, the difference was statistically significant （21% vs 41% ）χ^2 = 4.82, P =0. 028）. In patients who completed 8--week trail, symptom improvement rate in escitalopram group was 90.3% vs 86.6% in fluoxetine group, the difference was not statistically significant （ χ^2 = 1. 282, P = 0. 673） ; ITT analysis showed that at the end of 8-- week observation, no statistical difference in effecacy was found between two groups, while escitalopram treatment group showed earlier improvement in depression and anxiety symptom score, and rate of adverse reactions was lower than that of fluoxetine group. Conclusions Escitalopram in the treatment of elderly patients with depression has better efficacy and tolerance than fluoxetine.