March John S, Klee Brian J, Kremer Charlotte M E
Department of Psychiatry and Behavioral Sciences, Duke Child and Family Study Center, Duke University Medical Center, Durham, North Carolina 27710, USA.
J Child Adolesc Psychopharmacol. 2006 Feb-Apr;16(1-2):91-102. doi: 10.1089/cap.2006.16.91.
The aim of this study was to examine the balance between the benefits of treatment and the risk of suicidality in children and adolescents in multicenter, randomized, controlled trials of sertraline versus placebo.
The published literature was searched for multicenter, randomized, placebo-controlled trials of sertraline for pediatric mental disorders. Four trials were identified: Two (pooled) in pediatric major depressive disorder (MDD; Wagner 2003) and two in obsessive-compulsive disorder (OCD; March et al. 1998; POTS Team 2004). Using intent-to-treat (ITT) analysis populations, the authors calculated the number needed to treat (NNT) for response and remission and the number needed to harm (NNH) for suicidality, and their ratio, for each clinical trial.
NNTs ranged from 2 to 10, indicating clinically meaningful benefits. Benefit was greater for OCD than for MDD, and for adolescents as compared with children in MDD. No age effect was apparent for OCD. Suicidality was reported in 8 patients (5 assigned to sertraline and 3 assigned to placebo). All but 1 (a placebo-treated patient in the Pfizer OCD trial) were enrolled in the sertraline MDD trial. The NNH for suicidality in MDD was 64. Treatment emergent suicidality was more common in children (NNH 28.7) than in adolescents (NNH 706.3). Because no patient developed suicidality in sertraline-treated OCD patients, the NNH for sertraline in OCD approaches infinity.
With the stipulation that doctor and patient preferences necessarily play a critical role in the choice of treatment, NNT to NNH ratios indicate a positive benefit-to-risk ratio for sertraline in adolescents with MDD and in patients of all ages with OCD.
本研究旨在探讨在舍曲林与安慰剂对比的多中心、随机、对照试验中，儿童及青少年治疗获益与自杀风险之间的平衡。
检索已发表文献，查找舍曲林用于儿童精神障碍的多中心、随机、安慰剂对照试验。共识别出四项试验：两项（合并）针对儿童重度抑郁症（MDD；瓦格纳，2003年），两项针对强迫症（OCD；马奇等人，1998年；小儿强迫症治疗研究团队，2004年）。作者使用意向性治疗（ITT）分析人群，计算每项临床试验中反应和缓解所需治疗人数（NNT）以及自杀所需伤害人数（NNH）及其比值。
NNT范围为2至10，表明具有临床意义的获益。强迫症的获益大于重度抑郁症，且在重度抑郁症中，青少年的获益大于儿童。强迫症未显示出年龄效应。有8例患者报告有自杀行为（5例分配至舍曲林组，3例分配至安慰剂组）。除1例（辉瑞强迫症试验中接受安慰剂治疗的患者）外，所有患者均纳入舍曲林重度抑郁症试验。重度抑郁症中自杀行为的NNH为64。治疗中出现的自杀行为在儿童中（NNH 28.7）比在青少年中（NNH 706.3）更常见。由于舍曲林治疗的强迫症患者中无患者出现自杀行为，舍曲林在强迫症中的NNH接近无穷大。
规定医生和患者的偏好必然在治疗选择中起关键作用，NNT与NNH比值表明舍曲林对患有重度抑郁症的青少年以及所有年龄段的强迫症患者具有积极的获益风险比。
