艾司西酞普兰与帕罗西汀对重度抑郁症患者长期治疗效果的比较研究。
A comparative study of the efficacy of long-term treatment with escitalopram and paroxetine in severely depressed patients.
作者信息
Boulenger J-P, Huusom A K T, Florea I, Baekdal T, Sarchiapone M
机构信息
University Department of Adult Psychiatry, CHU de Montpellier and INSERM E361, France.
出版信息
Curr Med Res Opin. 2006 Jul;22(7):1331-41. doi: 10.1185/030079906X115513.
OBJECTIVE
This randomised, double-blind, fixed-dose study evaluated the efficacy of escitalopram and paroxetine in the long-term treatment of severely depressed patients with major depressive disorder (MDD).
RESEARCH DESIGN AND METHODS
Patients with a primary diagnosis of MDD and baseline Montgomery-Asberg Depression Rating Scale (MADRS) >or= 30 were randomised to 24 weeks of double-blind treatment with fixed doses of either escitalopram (20 mg) (n = 232) or paroxetine (40 mg) (n = 227). The primary analysis of efficacy was an analysis of covariance (ANCOVA) of change from baseline to endpoint (Week 24) in MADRS total score (last observation carried forward, LOCF). MAIN OUTCOME MEASURES;
RESULTS
At endpoint (24 weeks), the mean change from baseline in MADRS total score was -25.2 for patients treated with escitalopram (n = 228) and -23.1 for patients with paroxetine (n = 223), resulting in a difference of 2.1 points (p < 0.05). The difference in the change in the MADRS total score (LOCF) was significantly in favour of escitalopram from Week 8 onwards. The proportion of remitters (MADRS <or= 12) after 24 weeks was 75% for escitalopram and 67% for paroxetine (p < 0.05). The results on the primary efficacy scale were supported by significantly greater differences in favour of escitalopram on the Hamilton Anxiety, Hamilton Depression and Clinical Global Impression-Improvement and -Severity scales. For very severely depressed patients (baseline MADRS >or= 35), there was a difference of 3.4 points at endpoint in the MADRS total score in favour of escitalopram (p < 0.05). The overall withdrawal rate for patients treated with escitalopram (19%) was significantly lower than with paroxetine (32%) (p < 0.01). The withdrawal rate due to adverse events was significantly lower for escitalopram (8%) compared to paroxetine (16%) (p < 0.05). There were no significant differences in the incidence of individual adverse events during treatment.
CONCLUSION
Escitalopram is significantly more effective than paroxetine in the long-term treatment of severely depressed patients.
目的
本随机、双盲、固定剂量研究评估了艾司西酞普兰和帕罗西汀对重度抑郁症（MDD）患者的长期治疗效果。
研究设计与方法
原发性诊断为MDD且蒙哥马利-艾斯伯格抑郁评定量表（MADRS）基线评分≥30的患者被随机分配，接受为期24周的双盲治疗，分别服用固定剂量的艾司西酞普兰（20毫克）（n = 232）或帕罗西汀（40毫克）（n = 227）。疗效的主要分析是对从基线到终点（第24周）MADRS总分变化（末次观察值结转，LOCF）进行协方差分析（ANCOVA）。主要观察指标；
结果
在终点（24周）时，接受艾司西酞普兰治疗的患者（n = 228）MADRS总分较基线的平均变化为-25.2，接受帕罗西汀治疗的患者（n = 223）为-23.1，差异为2.1分（p < 0.05）。从第8周起，MADRS总分（LOCF）变化的差异显著有利于艾司西酞普兰。24周后，艾司西酞普兰组的缓解者（MADRS≤12）比例为75%，帕罗西汀组为67%（p < 0.05）。在汉密尔顿焦虑量表、汉密尔顿抑郁量表以及临床总体印象-改善和-严重程度量表上，显著更有利于艾司西酞普兰的差异支持了主要疗效量表的结果。对于非常严重抑郁的患者（基线MADRS≥35），终点时MADRS总分差异为3.4分，有利于艾司西酞普兰（p < 0.05）。接受艾司西酞普兰治疗的患者总体退出率（19%）显著低于帕罗西汀组（32%）（p < 0.01）。因不良事件导致的退出率，艾司西酞普兰（8%）显著低于帕罗西汀（16%）（p < 0.05）。治疗期间个体不良事件的发生率无显著差异。
结论
在对重度抑郁症患者的长期治疗中，艾司西酞普兰比帕罗西汀显著更有效。
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