Medical Statistics Group, ScHARR, University of Sheffield, Sheffield, UK.
Stat Methods Med Res. 2013 Apr;22(2):190-218. doi: 10.1177/0962280211432210. Epub 2012 Jan 19.
A number of meta-analyses have been undertaken to assess both the safety and efficacy of antidepressants in paediatric and adolescent patients. This article updates the analyses with additionally reported trials. The aim of this analysis was to investigate whether antidepressant treatments are associated with an increased risk of suicide-related outcomes in paediatric and adolescent patients. Also, in the same population, to assess whether antidepressant treatments are beneficial in terms of efficacy. A meta-analysis of randomised controlled trials of antidepressant treatments compared with placebo in paediatric and adolescent patients was undertaken of 6039 individuals participating in 35 randomised controlled trials. For suicide-related outcomes suicidal behaviour, suicidal ideation and suicidal behaviour or ideation were examined. These data presented the additional problem of the events of interest being rare. An analysis was described in this article to account for the rare events that also included studies which had no events on either treatment arm. There were trends to indicate that active treatments increased the risk of these events in absolute terms. For efficacy, the results indicated that antidepressant treatments did have a statistically significant effects compared to placebo but the effect was less for the trials in depression. The results are in the main consistent with previous meta-analyses on a smaller number of trials. There was evidence of an increased risk in suicide-related outcomes on antidepressant treatments, while antidepressant treatments were also shown to be efficacious.
已经进行了多项荟萃分析，以评估抗抑郁药在儿科和青少年患者中的安全性和疗效。本文更新了分析结果，增加了报告的试验。本分析的目的是调查抗抑郁治疗是否与儿科和青少年患者自杀相关结局的风险增加有关。此外，在同一人群中，评估抗抑郁治疗在疗效方面是否有益。对 35 项随机对照试验中 6039 名参与者进行了抗抑郁治疗与安慰剂治疗比较的随机对照试验荟萃分析。对于自杀相关结局，研究了自杀行为、自杀意念和自杀行为或意念。这些数据提出了一个额外的问题，即感兴趣的事件很少见。本文描述了一种分析方法，以解释罕见事件，该方法还包括在两个治疗组都没有事件的研究。有趋势表明，积极治疗会增加这些事件的绝对风险。对于疗效，结果表明，与安慰剂相比，抗抑郁治疗确实有统计学意义上的效果，但在抑郁症试验中效果较小。结果与之前关于较少试验的荟萃分析基本一致。抗抑郁治疗与自杀相关结局的风险增加有关，而抗抑郁治疗也显示出疗效。
