在儿童抑郁症中选择性血清素再吸收抑制剂:发表与未发表数据的系统审查
Craig J Whittington1, Tim Kendall, Peter Fonagy
1Centre for Outcomes Research and Effectiveness, Subdepartment of Clinical Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK. c.whittington@ucl.ac.uk
Lancet (London, England)
|April 28, 2004
概括
关于治疗儿童抑郁症的抗抑郁药的公布数据是不完整的. 包括未发表的试验数据显示,风险可能会超过大多数选择性血清素再吸收抑制剂 (SSRI) 的益处,除了fluoxetine.
科学领域:
- 儿科精神病学 儿科精神病学
- 临床药理学 临床药理学
- 基于证据的医学基于证据的医学.
背景情况:
- 对于选择性血清素再吸收抑制剂 (SSRI) 用于治疗儿童抑郁症的安全性存在担忧.
- 对SSRI风险和益处的全面评估需要检查公布和未公布的试验数据.
研究的目的:
- 为了比较和对比已公布和未公布的关于SSRI在儿童抑郁症治疗中的风险和益处的数据.
- 在考虑所有可用的证据时,评估SSRI的整体风险-收益概况.
主要方法:
- 进行了随机对照试验 (RCT) 的元分析,比较5-18岁儿童的SSRI与安慰剂.
- 包含的试验是同行评审的公布和未公布的监管审查数据.
- 评估的结果包括治疗缓解,反应,症状得分,严重不良事件,与自杀有关的行为和停止治疗.
主要成果:
- 已公布的数据表明,fluoxetine具有有利的风险-益处概况.
- 对于帕罗克塞丁和塞特拉林,公布的数据显示了模两可或微弱的益处,但未公布的数据表明风险超过益处.
- 西塔洛普拉姆和文拉法辛未发表的试验表明风险-益处概况不利.
结论:
- 虽然已公布的数据可能表明一些SSRI的风险-收益概况有利,但将未公布的数据纳入其中,揭示了对大多数人 (不包括fluoxetine) 的潜在风险超过收益.
- 不完整的试验发表可能导致对儿科抑郁症的治疗建议不准确.
- 报告所有干预研究数据的透明度提高对于明智的临床决策和准则制定至关重要.
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