艾司西酞普兰与帕罗西汀治疗老年性抑郁症对照研究

Efficacy and safety of escitalopram in elderly patients with major depression:A randomized and control study

目的:研究艾司西酞普兰治疗老年性抑郁症的疗效和安全性。方法:采用随机对照、开放性设计,将107例在精神病专科医院接受门诊和住院治疗的老年性抑郁症患者随机分配到两组,艾司西酞普兰治疗组52例,帕罗西汀治疗组55例,疗程8周。用汉密尔顿抑郁量表(Hamilton Rating Scale for Depres-sion,HRSD)和老年抑郁量表(Geriatric Depression Scale,GDS)评估患者疗效。用副反应量表(Treat-ment Emergent Symptom Scale,TESS)评估患者的药物不良反应。疗效分析采用意向性分析法(Intent to Treat Analysis,ITT),对中途退出或失访的病例采用末次分析截转法(Last Observation Carried Forward,LOCF)处理缺失值。结果:艾司西酞普兰组治疗期间脱落率低于帕罗西汀组(21.1%vs.40.0%,P=0.034)。在治疗8周末,艾司西酞普兰组患者痊愈10例(19.23%),显著进步11例(21.2%),好转17例(32.7%),无变化14例(26.9%);帕罗西汀组痊愈9例(16.4%),显著进步12例(21.8%),好转21例(38.2%),变化13例(23.6%),两组差异无统计学意义(P>0.05)。艾司西酞普兰治疗组抑郁症状评分改善的时间早于帕罗西汀组[治疗第一周末艾司西酞普兰组GDS分(13.7±4.5)低于帕罗西汀组(17.3±5.1),P<0.001;治疗第二周末艾司西酞普兰组HRSD评分(16.6±3.5)低于帕罗西汀组(24.4±6.1),P<0.001),且不良反应率低于帕罗西汀组(28.8%vs.47.3%,P<0.05)]。结论:与帕罗西汀相比,艾司西酞普兰治疗老年性抑郁症患者起效快和不良反应发生率低。

Objective： To evaluate the efficacy and safety of escitalopram in elderly patients with major depression. Method： This was an 8 weeks, randomized control and open-label study. Totally 107 elderly patients were randomly assigned to escitalopram group { n = 52 } or paroxetin group { n = 55 ] . The efficacy was evaluated with the Hamilton Rating Scale for Depression { HRSD ） and Geriatric Depression Seale{ GDS ） . The Treatment Emergent Symptom Scale { TESS } was used to evaluate the side effects caused by the antidepressants. Intent to Treat Analysis （TTT） was used to process study data, and Last Observation Carried Forward （LOCF） was adopted to deal with missing value caused by withdrawing patients during 8-week observation. Resdts： The 8-week drop rate in escitalopram group was lower than that in paroxetine group （ 21% vs. 40. 0%, P =0. 034 } . In patients who completed 8-week trial, the difference of symptom improvement rate between eseitalopram group and paroxetine group was not statistically significant { P 〉0. 05 } . ITr analysis showed that at the end of 8-week observation, there was no statistically difference in efficacy between the two groups. But eseitalopram group showed earlier improvement in depressive symptoms than paroxetine group （ e. g. GDS score at the end of the 1st week, { 13.7 ± 4.5 } vs. {17.3±5.1）, P〈0.001; HRSD score at the end of the 2nd week, （16.6±3.5） vs. （24.4±6.1）, P〈0. 001 ）, and lower rate of adverse reactions than paroxetine group （28. 8% vs. 47. 3%, P 〈0. 05 ） . Conclusion： Escitalopram in the treatment of depression in elderly patients may have better efficacy and tolerance than paroxetine.