Llorca P M, Brousse G, Schwan R
Centre Medico-Psychologique B, Centre Hospitalier Universitaire, BP 69, 63003 Clermont-Ferrand.
Encephale. 2005 Jul-Aug;31(4 Pt 1):490-501. doi: 10.1016/s0013-7006(05)82410-8.
Escitalopram is a selective serotonin reuptake inhibitor (SSRI); it is the therapeutically active S-enantiomer of the racemic mixture, citalopram. This review aimed to compare the efficacy and tolerability of escitalopram versus citalopram and several other SSRIs (citalopram, fluoxetine, paroxetine, sertraline), and a selective reuptake inhibitor of noradrenaline and serotonin, venlafaxine XR, for treatment of DSM IV (Diagnostic and Statistical Manual of mental disorders - fourth edition) major depressive disorder, based on the studies evaluated by the Commission de la Transparence de la R6publique Frangaise, and data from a pooled analysis presented in 2005 at the 158th annual congress of the American Psychiatric Association. Change from baseline to end-point on total MADRS (Montgomery-Asberg Depression Rating Scale--10 items, score range: 0-60) was the primary efficacy parameter; changes on HAM-D17 (Hamilton rating scale for depression--17 items), CGI-S and CGI-I (Clinical global Impression-Severity and-Improvement), and response rates (> or = 50% MADRS score reduction) and remissions (< 12 MADRS score) were the secondary efficacy parameters. Tolerability assessment was based on the numbers and rates of adverse events observed with treatment, and the DESS (Discontinuation Emergent Signs and Symptoms-43 items) scale was used for assessment of adverse events observed with treatment withdrawal. Analyses were based on intention to treat using the LOCF (last observation carried forward) method. Efficacy of escitalopram appeared to be at least equivalent to that of the active comparators in all cases. The difference between active compounds was more marked when depressive symptoms were more severe. From the point of view of tolerability, frequency of adverse effects occurring on treatment and the frequency of treatment discontinuations due to adverse effects were comparable with both escitalopram and the active comparators; however, the comparisons were mostly favourable to escitalopram, though differences were generally not statistically significant. In both studies of escitalopram versus venlafaxine XR, treatment discontinuations due to adverse events were less frequent on escitalopram than on venlafaxine XR (7.5% vs 11.2%, and 4.1% vs 16.0% respectively). With regard to adverse events associated with the withdrawal period, the signs and symptoms occurring on treatment discontinuation assessed after 1 week using the DESS scale were less frequent on escitalopram than on venlafaxine XR at 8 weeks and paroxetine at 24 weeks. Concerning suicide risk, a review of clinical trials involving 2277 patients on escitalopram and 1814 patients on placebo showed that this risk was minimal, and similar in both groups; moreover, no evidence was found suggesting that escitalopram might promote suicidal behaviour compared with placebo. These results suggest that escitalopram is suitable to be considered as a first-line drug treatment for major depressive disorder.
艾司西酞普兰是一种选择性5-羟色胺再摄取抑制剂(SSRI);它是消旋混合物西酞普兰中具有治疗活性的S-对映体。本综述旨在基于法国共和国透明度委员会评估的研究以及2005年在美国精神病学协会第158届年会上发表的汇总分析数据,比较艾司西酞普兰与西酞普兰以及其他几种SSRI(西酞普兰、氟西汀、帕罗西汀、舍曲林),还有一种去甲肾上腺素和5-羟色胺的选择性再摄取抑制剂文拉法辛缓释剂治疗《精神疾病诊断与统计手册》第四版(DSM-IV)重度抑郁症的疗效和耐受性。从基线到终点时蒙哥马利-艾斯伯格抑郁评定量表(MADRS,10项,评分范围:0 - 60)的变化是主要疗效参数;汉密尔顿抑郁评定量表(HAM-D17,17项)、临床总体印象严重程度(CGI-S)和临床总体印象改善情况(CGI-I)的变化,以及缓解率(MADRS评分降低≥50%)和痊愈率(MADRS评分<12)是次要疗效参数。耐受性评估基于治疗中观察到的不良事件数量和发生率,停药出现的症状和体征量表(DESS,43项)用于评估停药时观察到的不良事件。分析采用末次观察结转(LOCF)方法按意向性治疗进行。在所有情况下,艾司西酞普兰的疗效似乎至少与活性对照药物相当。当抑郁症状更严重时,活性化合物之间的差异更为明显。从耐受性角度来看,治疗中出现不良反应的频率以及因不良反应而停药的频率在艾司西酞普兰和活性对照药物中相当;然而,比较结果大多对艾司西酞普兰有利,尽管差异通常无统计学意义。在艾司西酞普兰与文拉法辛缓释剂的两项研究中,因不良事件导致停药的情况在艾司西酞普兰组比文拉法辛缓释剂组更少见(分别为7.5%对11.2%和4.1%对16.0%)。关于与停药期相关的不良事件,使用DESS量表在停药1周后评估的停药时出现的症状和体征,在艾司西酞普兰组比8周时的文拉法辛缓释剂组以及24周时的帕罗西汀组更少见。关于自杀风险,一项对涉及2277例服用艾司西酞普兰患者和1814例服用安慰剂患者的临床试验的综述表明,这种风险极小,且两组相似;此外,未发现证据表明与安慰剂相比,艾司西酞普兰可能会促发自杀行为。这些结果表明,艾司西酞普兰适合被视为重度抑郁症的一线药物治疗。