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艾司西酞普兰与文拉法辛缓释剂治疗重度抑郁症的双盲对照研究

A double-blind comparison of escitalopram and venlafaxine extended release in the treatment of major depressive disorder.

作者信息

Bielski Robert J, Ventura Daniel, Chang Chung-Chi

机构信息

Summit Research Network, Okemos, MI 48864, USA.

出版信息

J Clin Psychiatry. 2004 Sep;65(9):1190-6. doi: 10.4088/jcp.v65n0906.

Abstract

BACKGROUND

Escitalopram is the most selective serotonin reuptake inhibitor (SRI) antidepressant available. Venlafaxine is a non-selective SRI that also inhibits noradrenergic re-uptake. This study compared escitalopram and venlafaxine extended release (XR) in depressed outpatients at the highest doses recommended in the United States.

METHOD

In this randomized trial, patients (diagnosis of DSM-IV-defined major depressive disorder; baseline Hamilton Rating Scale for Depression score of >/= 20) received 1 week of single-blind placebo treatment, followed by 8 weeks of double-blind, fixed-dose treatment with either escitalopram or venlafaxine XR (rapidly titrated to 20 mg/day and 225 mg/day, respectively, in accordance with prescribing information). The primary efficacy variable was change from baseline to week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. Data were collected from May to December 2002.

RESULTS

Mean baseline MADRS scores for the escitalopram (N = 97) and venlafaxine XR (N = 98) groups were 30.7 and 30.0, respectively. There were no significant differences in measures of efficacy between the 2 antidepressants. Mean changes from baseline to endpoint in MADRS total score for escitalopram and venlafaxine XR were -15.9 and -13.6, respectively. Remission (MADRS score of </= 10) rates at endpoint were 41.2% for escitalopram and 36.7% for venlafaxine XR. Response (>/= 50% reduction from baseline MADRS score) rates for the escitalopram and venlafaxine XR groups were 58.8% and 48.0%, respectively. Tolerability measures favored escitalopram over venlafaxine XR treatment. The venlafaxine XR group had a higher incidence than the escitalopram group of treatment-emergent adverse events (85.0% vs. 68.4%) and discontinuation due to adverse events (16.0% vs. 4.1%; p <.01).

CONCLUSION

Results of this study indicate that, when titrated rapidly to their maximum recommended doses, escitalopram is at least as effective as venlafaxine XR and significantly better tolerated. These results do not support the hypothesis that nonselective SRIs have greater efficacy than selective SRIs.

摘要

背景

艾司西酞普兰是目前选择性最高的5-羟色胺再摄取抑制剂(SRI)类抗抑郁药。文拉法辛是一种非选择性SRI,它还能抑制去甲肾上腺素的再摄取。本研究在美国推荐的最高剂量下,对艾司西酞普兰和文拉法辛缓释剂(XR)在门诊抑郁症患者中的疗效进行了比较。

方法

在这项随机试验中,患者(诊断为DSM-IV定义的重度抑郁症;汉密尔顿抑郁量表基线评分≥20)接受为期1周的单盲安慰剂治疗,随后进行为期8周的双盲、固定剂量治疗,分别使用艾司西酞普兰或文拉法辛XR(根据处方信息迅速滴定至每日20毫克和225毫克)。主要疗效变量是蒙哥马利-艾斯伯格抑郁量表(MADRS)总分从基线到第8周的变化。数据收集于2002年5月至12月。

结果

艾司西酞普兰组(N = 97)和文拉法辛XR组(N = 98)的平均基线MADRS评分分别为30.7和30.0。两种抗抑郁药在疗效指标上没有显著差异。艾司西酞普兰和文拉法辛XR从基线到终点的MADRS总分平均变化分别为-15.9和-13.6。终点时的缓解率(MADRS评分≤10),艾司西酞普兰组为41.2%,文拉法辛XR组为36.7%。艾司西酞普兰组和文拉法辛XR组的反应率(MADRS评分较基线降低≥50%)分别为58.8%和48.0%。耐受性指标显示艾司西酞普兰优于文拉法辛XR治疗。文拉法辛XR组治疗中出现的不良事件发生率高于艾司西酞普兰组(85.0%对68.4%),因不良事件停药的发生率也更高(16.0%对4.1%;p <.01)。

结论

本研究结果表明,当迅速滴定至最大推荐剂量时,艾司西酞普兰至少与文拉法辛XR疗效相当,且耐受性显著更好。这些结果不支持非选择性SRI比选择性SRI疗效更好的假设。

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