Montgomery Stuart A, Andersen Henning F
Imperial College School of Medicine, University of London, London, UK.
Int Clin Psychopharmacol. 2006 Sep;21(5):297-309. doi: 10.1097/00004850-200609000-00008.
This article reanalyses and reviews data from the two published randomized clinical trials comparing escitalopram and venlafaxine XR in the treatment of patients with major depressive disorder. The aim was to further compare the efficacy and tolerability of escitalopram and venlafaxine XR and to assess the impact of the two treatments on the patient's quality of life, as well as the benefit/risk of treatment. A total of 243 escitalopram-treated patients and 240 venlafaxine XR-treated patients were included in this analysis. Comparable treatment efficacy was achieved with respect to the prospectively defined primary efficacy endpoint (mean change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) total score at week 8). An analysis of the outcome at the end of study by baseline severity showed that the treatment difference became greater the more severely depressed the patients were at baseline. At the highest permitted doses, in the subgroup of patients who were severely depressed (baseline MADRS > or =30), patients treated with escitalopram had a statistically significantly greater improvement (P<0.05) in mean MADRS total scores than patients treated with venlafaxine XR at endpoint. For these patients, treatment with 20 mg/day escitalopram resulted in a statistically significantly (P<0.05) higher remission rate at week 8 (47%) than treatment with venlafaxine XR (29%). This difference was confirmed by the analysis of the pooled data, which showed that patients in the escitalopram group had a significantly (P<0.05) higher mean number of depression-free days (30.4 days) than those in the venlafaxine XR group (26.2 days) over the 8-week period. The relative benefit of escitalopram versus venlafaxine XR was 1.46, indicating that a patient was more likely to benefit from treatment with escitalopram. The proportions of patients who withdrew owing to adverse events were 7.5% in the escitalopram group and 11.2% in the venlafaxine XR group. The mean number of discontinuation emergent signs and symptoms in the venlafaxine XR group (mean: 5.0) was significantly (P<0.001) higher than for the escitalopram group (mean: 2.4).
本文重新分析并回顾了两项已发表的随机临床试验数据，这两项试验比较了艾司西酞普兰和文拉法辛缓释剂治疗重度抑郁症患者的疗效。目的是进一步比较艾司西酞普兰和文拉法辛缓释剂的疗效和耐受性，评估两种治疗方法对患者生活质量的影响以及治疗的获益/风险。本分析共纳入了243例接受艾司西酞普兰治疗的患者和240例接受文拉法辛缓释剂治疗的患者。就预先定义的主要疗效终点（第8周时蒙哥马利-阿斯伯格抑郁评定量表（MADRS）总分相对于基线的平均变化）而言，两种治疗方法取得了相当的疗效。根据基线严重程度对研究结束时的结果进行分析表明，患者在基线时抑郁越严重，治疗差异就越大。在最高允许剂量下，在重度抑郁患者亚组（基线MADRS≥30）中，接受艾司西酞普兰治疗的患者在终点时MADRS总分的平均改善程度在统计学上显著高于接受文拉法辛缓释剂治疗的患者（P<0.05）。对于这些患者，在第8周时，每天服用20mg艾司西酞普兰治疗的缓解率（47%）在统计学上显著高于（P<0.05）服用文拉法辛缓释剂治疗的缓解率（29%）。汇总数据分析证实了这一差异，结果显示在8周期间，艾司西酞普兰组患者的无抑郁天数平均数（30.4天）显著高于（P<0.05）文拉法辛缓释剂组患者（26.2天）。艾司西酞普兰相对于文拉法辛缓释剂的相对获益为1.46，这表明患者更有可能从艾司西酞普兰治疗中获益。因不良事件而退出治疗的患者比例在艾司西酞普兰组为7.5%，在文拉法辛缓释剂组为11.2%。文拉法辛缓释剂组停药后出现的体征和症状的平均数（平均：5.0）显著高于（P<0.001）艾司西酞普兰组（平均：2.4）。
