Wade Alan, Friis Andersen Henning
CPS Clinical Research Centre, Glasgow, UK.
Curr Med Res Opin. 2006 Nov;22(11):2101-10. doi: 10.1185/030079906X148319.
To analyse the significance of 'onset of effect' on clinical outcome in the treatment of depression and the contribution of individual Montgomery-Asberg Depression Rating Scale (MADRS) items to improvements in the MADRS total score.
All five published placebo-controlled clinical studies in depression as per January 1, 2005, with escitalopram, were included in this pooled analysis.
Of the 1636 patients who were randomised to either escitalopram (882) or placebo (754), 1333 completed 8 weeks of treatment (707 escitalopram and 626 placebo). A statistically significant difference (p < 0.05) between the MADRS total score responses of escitalopram and placebo treatments was observed at week 1. All 10 MADRS single items showed a significant treatment effect at week 8. For items representing core symptoms of depression (apparent sadness, reported sadness, inner tension, concentration difficulties, inability to feel, pessimistic thoughts and suicidal thoughts) the effect was detected early (week 1) and for other items (reduced sleep, reduced appetite and lassitude) the effect was detected later (week 6-8). Of the patients who showed an onset of effect (> or = 20% reduction in MADRS) after 2 weeks, and who remained on escitalopram until week 8, 63% were in remission at week 8 (mean MADRS score of 6.1).
Onset of treatment response at 2 weeks is an important indicator of subsequent remission at 8 weeks. It would therefore be a reasonable clinical recommendation that if patients fail to show a measurable clinical improvement within 2 weeks, a dose increase should be considered at this time.
分析“起效”对抑郁症治疗临床结局的意义,以及蒙哥马利-艾斯伯格抑郁量表(MADRS)各单项对MADRS总分改善的贡献。
纳入2005年1月1日之前发表的所有五项使用艾司西酞普兰的抑郁症安慰剂对照临床研究进行汇总分析。
1636例随机分组至艾司西酞普兰组(882例)或安慰剂组(754例)的患者中,1333例完成了8周治疗(707例艾司西酞普兰组和626例安慰剂组)。在第1周时,观察到艾司西酞普兰与安慰剂治疗的MADRS总分反应存在统计学显著差异(p < 0.05)。所有10个MADRS单项在第8周时均显示出显著治疗效果。对于代表抑郁核心症状的条目(明显悲伤、自述悲伤、内心紧张、注意力不集中、情感麻木、悲观想法和自杀念头),效果在早期(第1周)即被检测到,而对于其他条目(睡眠减少、食欲减退和倦怠),效果在后期(第6 - 8周)被检测到。在2周后显示起效(MADRS降低≥20%)且持续使用艾司西酞普兰至第8周的患者中,63%在第8周时达到缓解(MADRS平均分为6.1)。
2周时出现治疗反应是8周后缓解的重要指标。因此,合理的临床建议是,如果患者在2周内未显示出可测量的临床改善,此时应考虑增加剂量。