Efficacy and safety of atomoxetine for attention-deficit/hyperactivity disorder in children and adolescents-meta-analysis and meta-regression analysis
Efficacy and safety of atomoxetine for attention-deficit/hyperactivity disorder in children and adolescents-meta-analysis and meta-regression analysis
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DOI：
10.1007/s00213-007-0840-x
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发表时间：
2007-10-01
影响因子：
3.4
通讯作者：
Ng, Emil M. L.
中科院分区：
文献类型：
--
作者：
Cheng, Jackie Y. W.;Chen, Ronald Y. L.;Ng, Emil M. L.
目的本研究的目的是评估托莫西汀在儿童和青少年中的疗效和安全性。材料和方法我们通过Medline，PubMed，PsychInfo和科克伦对照试验中心注册中心（CENTRAL 2006第3期），使用与托莫西汀和注意力缺陷/多动障碍（ADHD）相关的关键词，并通过参考文献列表进行扫描。我们纳入了9个随机安慰剂对照试验（托莫西汀：安慰剂= 1，150：678）。结果托莫西汀在减轻ADHD症状方面上级安慰剂（p < 0.01），在不同评分者（家长、教师、临床医生）评定的不同量表（注意缺陷/多动障碍评定量表-IV、Conners父母和教师评定量表-修订版：简表、临床总体印象-严重程度）方面均优于安慰剂。治疗缓解和复发预防的需要治疗数量（NNT）分别为3.43（95% CI，2.79-4.45）和10.30（95% CI，5.89-40.62）。高基线ADHD症状（p=0.02）与ADHD症状的更大减少相关，而男性（p=0.02），共病对立违抗性障碍（ODD）状态（p=0.01）和ADHD多动/冲动亚型（p=0.01）与较小的减少相关。最常见的不良事件为胃肠道[食欲下降，需要伤害的次数（NNH）=8.81;腹痛，NNH=22.48;呕吐，NNH=29.96;消化不良，NNH=49.38]和睡眠相关（嗜睡，NNH=19.41）。年轻（p=0.03）和高基线多动/冲动症状（p < 0.01）与更多的不良事件相关，而ADHD注意力不集中亚型（p=0.04）与较少的不良事件相关。托莫西汀治疗改善了使用儿童健康问卷（CHQ）的生活质量（p < 0.01）。ADHD+ODD共病组ADHD和ODD症状均减少（p < 0.01），ODD状态与更多不良事件无关。共病广泛性焦虑障碍或抑郁症的疗效和副作用没有改变。结论托莫西汀是有效的，在减少ADHD症状。它可能在治疗共病的ODD或抑郁症中起作用，并且可能在共病的焦虑症中起作用。
Objectives The objective of this study was to evaluate the efficacy and safety of atomoxetine in children and adolescents.Materials and methods We searched for studies published between 1985 and 2006 through Medline, PubMed, PsychInfo and Cochrane Central Register of Controlled Trials (CENTRAL 2006 Issue 3) using keywords related to atomoxetine and attention-deficit/hyperactivity disorder (ADHD) and scanned though reference lists. We included nine randomized placebo-controlled trials (atomoxetine:placebo=1,150:678).Results Atomoxetine was superior (p < 0.01) to placebo in reducing ADHD symptoms across different scales (Attention-Deficit/Hyperactivity Disorder Rating Scale-IV, Conners' Parent and Teacher Rating Scales-Revised:Short Form, Clinical Global Impression-Severity) rated by different raters (parent, teacher, clinician). The number-needed-to-treat (NNTs) for treatment response and relapse prevention were 3.43 (95% CI, 2.79-4.45) and 10.30 (95% CI, 5.89-40.62), respectively. High baseline ADHD symptoms (p=0.02) was associated with greater reduction in ADHD symptoms, whereas male gender (p=0.02), comorbid oppositional defiant disorder (ODD) status (p=0.01) and ADHD hyperactive/impulsive subtype (p=0.01) were associated with smaller reductions. The commonest adverse events were gastrointestinal [appetite decrease, number-needed-to-harm (NNH)=8.81; abdominal pain, NNH=22.48; vomiting, NNH=29.96; dyspepsia, NNH=49.38] and sleep related (somnolence, NNH=19.41). Young age (p=0.03) and high baseline hyperactive/impulsive symptoms (p < 0.01) were associated with more adverse events, whereas ADHD inattentive subtype (p=0.04) was associated with less adverse events. Quality of life using Child Health Questionnaire (CHQ) improved (p < 0.01) with atomoxetine treatment. Both ADHD and ODD symptoms (p < 0.01) were reduced in comorbid ADHD+ODD, and ODD status was not associated with more adverse events. Efficacy and side effects were not altered by comorbid general anxiety disorder or major depression.Conclusions Atomoxetine is efficacious in reducing ADHD symptoms. It may have a role in treating comorbid ODD or depression, and probably in comorbid anxiety.