Pedersen Anders Gersel
Drug Development, H. Lundbeck A/S, Copenhagen, Denmark.
Int Clin Psychopharmacol. 2005 May;20(3):139-43. doi: 10.1097/00004850-200505000-00003.
The escitalopram clinical trial database, consisting of all placebo-controlled and relapse prevention trials within major depressive disorder (MDD) and anxiety disorders, was analysed for specific adverse events indicative of suicidal behaviour (fatal suicide, non-fatal self-harm or suicidal thoughts) in relation to treatment. The number of events was low, with no fatal suicides in the first 2 weeks of treatment. There was one fatal suicide during the full treatment period on placebo (incidence 0.1%; rate 0.003), and none on escitalopram. None of these figures were significantly different between escitalopram (n=2277) and placebo (n=1814) patients. There was no indication that escitalopram provokes suicidal behaviour compared to placebo in either MDD or anxiety disorders. Based on efficacy ratings (Montgomery-Asberg Depression Rating Scale, item 10), escitalopram was more efficacious versus placebo in lowering suicidal thoughts from weeks 1 through 8 in the treatment of patients with MDD.
对艾司西酞普兰临床试验数据库进行了分析，该数据库包含重度抑郁症（MDD）和焦虑症领域内所有安慰剂对照试验和预防复发试验，以研究与治疗相关的、表明自杀行为的特定不良事件（致命自杀、非致命自残或自杀念头）。不良事件数量较少，治疗的前两周内无致命自杀事件。在整个治疗期间，安慰剂组有1例致命自杀事件（发生率0.1%；发生率为0.003），艾司西酞普兰组无致命自杀事件。在艾司西酞普兰组（n = 2277）和安慰剂组（n = 1814）患者之间，这些数字均无显著差异。没有迹象表明，在MDD或焦虑症中，与安慰剂相比，艾司西酞普兰会引发自杀行为。根据疗效评分（蒙哥马利-艾斯伯格抑郁量表，第10项），在治疗MDD患者时，从第1周到第8周，艾司西酞普兰在降低自杀念头方面比安慰剂更有效。
