Apter Alan, Lipschitz Alan, Fong Regan, Carpenter David J, Krulewicz Stan, Davies John T, Wilkinson Christel, Perera Philip, Metz Alan
Schneiders Childrens Medical Center of Israel, Sackler School of Medicine, Petah Tikva, Israel.
J Child Adolesc Psychopharmacol. 2006 Feb-Apr;16(1-2):77-90. doi: 10.1089/cap.2006.16.77.
The aim of this study was to summarize results of a blinded review of potential suicidal events and analyses comparing incidence rates between paroxetine- and placebo-treated pediatric patients.
One thousand one hundred ninety-one (1191) children and adolescents received paroxetine (n = 642) or placebo (n = 549) during placebo-controlled portions of all acute double-blind trials of paroxetine (n = 5). An expert panel blindly reviewed and categorized all identified cases detected by electronic and manual search of adverse events (AEs), serious AEs, and selected cases as suicidal or non-suicidal behavior. Incidence rates were calculated for suicide-related events and for rating scale items assessing suicidality.
Suicide-related events occurred more often in paroxetine (22 of 642, 3.4%) than placebo groups (5 of 549, 0.9%); odds ratio (OR) 3.86 (95% CI 1.45, 10.26; p = 0.003). All suicide-related events occurred in adolescents of at least 12 years, except for 1 of 156 paroxetine-treated children. All suicide attempts occurred in major depressive disorder (MDD); few suicide-related events occurred in patients with a primary anxiety disorder. Suicide item analyses did not reveal significant differences between paroxetine and placebo.
Adolescents treated with paroxetine showed an increased risk of suicide-related events. Suicidality rating scales did not show this risk difference. The presence of uncontrolled suicide risk factors, the relatively low incidence of these events, and their predominance in adolescents with MDD make it difficult to identify a single cause for suicidality in these pediatric patients.
本研究旨在总结对潜在自杀事件进行盲法评估的结果，并分析比较接受帕罗西汀治疗和接受安慰剂治疗的儿科患者的发病率。
在帕罗西汀的所有急性双盲试验（共5项）的安慰剂对照阶段，1191名儿童和青少年接受了帕罗西汀（n = 642）或安慰剂（n = 549）治疗。一个专家小组对通过电子和人工搜索不良事件（AE）、严重不良事件以及选定为自杀或非自杀行为的病例进行了盲法评估和分类。计算了自杀相关事件以及评估自杀倾向的量表项目的发病率。
帕罗西汀组（642例中的22例，3.4%）自杀相关事件的发生率高于安慰剂组（549例中的5例，0.9%）；优势比（OR）为3.86（95%可信区间1.45，10.26；p = 0.003）。除156例接受帕罗西汀治疗的儿童中有1例自杀相关事件外，所有自杀相关事件均发生在至少12岁的青少年中。所有自杀未遂事件均发生在重度抑郁症（MDD）患者中；原发性焦虑症患者中很少发生自杀相关事件。自杀项目分析未显示帕罗西汀组和安慰剂组之间存在显著差异。
接受帕罗西汀治疗的青少年自杀相关事件风险增加。自杀倾向量表未显示出这种风险差异。存在未得到控制的自杀风险因素、这些事件的发生率相对较低以及它们在MDD青少年中占主导地位，使得难以确定这些儿科患者自杀倾向的单一原因。
