Trkulja Vladimir
Vladimir Trkulja, Department of Pharmacology, Medical School, University of Zagreb, Salata 11, 10000 Zagreb, Croatia.
Croat Med J. 2010 Feb;51(1):61-73. doi: 10.3325/cmj.2010.51.61.
To evaluate clinical relevance of differences between escitalopram and citalopram (equimolar) for major depressive disorder.
Review and meta-analysis of comparative randomized controlled trials (RCT). Comparisons were in relation to Montgomery-Asberg depression rating scale (MADRS) score reduction at weeks 1 (5 RCTs), 4 (5 RCTs), 6 (4 RCTs), 8 (5 RCTs), and 24 (1 RCT); proportion of responders at weeks 2, 4, 6 (2 RCTs for each time point), 8 (5 RCTs), and 24 (1 RCT); clinical global impression-severity (CGI-S) reduction at weeks 6 (1 RCT), 8 (5 RCTs), and 24 (1 RCT), and discontinuation due to adverse events or inefficacy during short-term (up to 8 weeks) and medium-term (24 weeks) treatment.
MADRS reduction was greater with escitalopram, but 95% confidence intervals (CI) around the mean difference were entirely or largely below 2 scale points (minimally important difference) and CI around the effect size (ES) was below 0.32 ("small") at all time points. Risk of response was higher with escitalopram at week 8 (relative risk, 1.14; 95% CI, 1.04 to 1.26) but number needed to treat was 14 (95% CI, 7 to 111). All 95% CIs around the mean difference and ES of CGI-S reduction at week 8 were below 0.32 points and the limit of "small," respectively. Data for severe patients (MADRS> or =30) are scarce (only 1 RCT), indicating somewhat greater efficacy (response rate and MADRS reduction at week 8, but not CGI-S reduction) of escitalopram, but without compelling evidence of clinically relevant differences. Discontinuations due to adverse events or inefficacy up to 8 weeks of treatment were comparable. Data for the period up to 24 weeks are scarce and inconclusive.
Presently, the claims about clinically relevant superiority of escitalopram over citalopram in short-to-medium term treatment of major depressive disorder are not supported by evidence.
评估艾司西酞普兰与西酞普兰（等摩尔）治疗重度抑郁症时差异的临床相关性。
对比较随机对照试验（RCT）进行综述和荟萃分析。比较内容包括第1周（5项RCT）、第4周（5项RCT）、第6周（4项RCT）、第8周（5项RCT）和第24周（1项RCT）时蒙哥马利-艾斯伯格抑郁量表（MADRS）评分的降低情况；第2周、第4周、第6周（每个时间点2项RCT）、第8周（5项RCT）和第24周（1项RCT）时的缓解者比例；第6周（1项RCT）、第8周（5项RCT）和第24周（1项RCT）时临床总体印象-严重程度（CGI-S）的降低情况，以及短期（最长8周）和中期（24周）治疗期间因不良事件或无效而停药的情况。
艾司西酞普兰组的MADRS降低幅度更大，但各时间点平均差异的95%置信区间（CI）完全或大部分低于2个量表分值（最小重要差异），效应量（ES）的CI在所有时间点均低于0.32（“小”）。第8周时艾司西酞普兰组的缓解风险更高（相对风险，1.14；95%CI，1.04至1.26），但需治疗人数为14（95%CI，7至111）。第8周时CGI-S降低的平均差异和ES的所有95%CI分别低于0.32分和“小”的界限。重度患者（MADRS≥30）的数据较少（仅1项RCT），表明艾司西酞普兰的疗效略高（第8周时的缓解率和MADRS降低情况，但CGI-S降低情况并非如此），但缺乏临床相关差异的有力证据。治疗8周内因不良事件或无效而停药的情况相当。24周内的数据较少且无定论。
目前，关于艾司西酞普兰在重度抑郁症短期至中期治疗中比西酞普兰具有临床相关优势的说法尚无证据支持。
