托莫西汀治疗儿童注意缺陷多动障碍的疗效与安全性的系统评价

A Systematic Review of Therapeutic Efficacy and Safety of Atomoxetine in the Treatment of Attention Deficit Hyperactivity Disorder in Children

目的:系统评价托莫西汀治疗儿童注意缺陷多动障碍(ADHD)的疗性与安全性。方法:计算机检索Cochrane library、Medline、EMbase、中国生物医学文献数据库,查找托莫西汀治疗儿童ADHD的随机对照试验(RCT),采用Rev Man 5.1统计软件进行Meta分析。结果:共纳入17项RCT,包括2 548例患儿。Meta分析结果显示,治疗后托莫西汀组的注意缺陷/多动评定量表(ADHD-RS)总分值[MD=-7.53,95%CI(-9.56,-5.51),P<0.01]、ADHD-RS多动/冲动分量表分值[MD=-4.15,95%CI(-5.25,-3.06),P<0.01]、ADHD-RS注意缺陷分量表分值[MD=-3.80,95%C(I-5.08,-2.51),P<0.01]及临床总体印象-总体严重度量表(CGI-S)分值[MD=-0.74,95%C(I-1.23,-0.26),P<0.01]改善均显著优于对照组,两组比较差异有统计学意义;两组患儿治疗过程中脱落失访例数比较,差异无统计学意义[RR=1.00,95%C(I0.85,1.18),P=0.99];托莫西汀组患儿比对照组更容易发生恶心、呕吐、食欲减退、腹痛、头痛、头晕、倦怠、易激惹、疲劳、体质量下降等不良反应(P<0.05)。结论:托莫西汀治疗儿童ADHD具有良好的疗效,可显著改善儿童ADHD的多动/冲动以及注意缺陷,其耐受性与对照组无显著性差异,但应注意其不良反应。

OBJECTIVE：To evaluate therapeutic efficacy and safety of atomoxetine in the treatment of attention deficit hyperactivity disorder（ADHD）in children.METHODS：Retrieved from Cochrane library,Medline,EMbase and CBM,RCT about atomoxetine in the treatment of ADHD in children were collected and analyzed by Rev Man 5.1 software.RESULTS：A total of 17 RCT were included,involving 2 548 patients.Results of Meta-analysis showed that the improvement of ADHD-RS [MD=-7.53,95%CI（-9.56,-5.51）,P0.01],ADHD-RS Hyperactive/Impulsive [MD=-4.15,95%CI（-5.25,-3.06）,P0.01],ADHD-RS Inattention [MD=-3.80,95%CI（-5.08,-2.51）,P0.01] and CGI-S [MD=-0.74,95%CI（-1.23,-0.26）,P0.01] in atomoxetine group were significantly greater than in control group.There was no statistical difference in the number of lost to follow-up between 2 groups during treatment [RR=1.00,95%C（I0.85,1.18）,P=0.99].The incidence of nausea,vomiting,loss of appetite,abdominal pain,headache,dizziness,somnolence,irritability,fatigue and weight loss in atomoxetine group were higher than in control group（P0.05）.CONCLUSIONS：Atomoxetine is effective in the treatment of children with ADHD,and can improve hyperactivity/impulsivity and attention deficit in children with ADHD.No significant difference is observed in atomoxetine group and placbo group.But the side effects of them should be considered.