阿托莫西汀与哌甲酯治疗儿童注意缺陷多动障碍疗效与安全性的Meta分析

A Meta-analyses Comparing Atomoxetine with Methylphenidate for Treatement of Children with Attention-Deficit/Hyperactivity Disorder

目的系统评价阿托莫西汀与哌甲酯治疗儿童注意缺陷多动障碍的临床疗效。方法计算机检索Cochrane图书馆(2008年第2期)、PubMed(1970～2008)、EMbase(1971～2008)、Medscape(1990～2008)、CBM(1978～2008)、NRR(1950～2008),手工检索已发表与未发表的资料,收集有关阿托莫西汀与哌甲酯比较治疗儿童注意缺陷多动障碍的随机对照试验(RCT)。由两名评价者独立选择试验、提取资料和评估方法学质量,采用Cochrane协作网RevMan4.2.8软件进行统计分析。结果最终纳入3个RCT,共1597例患者。Meta分析结果显示,两组ADHD-RS量表总分数、多动/冲动分量表分值及CGI-ADHD-S量表分值差异均无统计学意义,其RR(95%CI)分别为–1.09(–5.35,3.16),–0.27(–2.85,2.31)和–0.06(–0.49,0.38)。而两组ADHD-RS注意缺陷分量表分值差异有统计学意义[RR–1.79,95%C(I–2.22,–1.35)],表明哌甲酯在注意缺陷评定分量表上优于阿托莫西汀。两组副反应也无差异。结论阿托莫西汀与哌甲酯比较,尚不能确定何者疗效更明显。由于纳入RCT太少,且测量指标为终点替代指标,故其长期疗效、对不同亚组患者作用的差别及其安全性等尚不明确,仍需开展更多高质量的RCT进一步验证。

Objective To assess atomoxetine and methylphenidate therapy for attention-deficit/hyperactivity disorder （ADHD） . Methods We electronically searched the Cochrane Library （Issue 2, 2008）, PubMed （1970 to 2008）, MEDLINE （1971 to 2008）, EMbase （1971 to 2008）, Medscape （1990 to 2008）, CBM （1978 to 2008）, and NRR （1950 to 2008）. We also hand-searched some published and unpublished references. Two independent reviewers extracted data. Quality was assessed by the Cochrane Reviewer＇s Handbook 4.0. Meta-analysis was conducted by The Cochrane Collaboration＇s RevMan 4.2.8 software. Results We finally identified 3 randomized controlled trials that were relevant to the study. Treatment response （reducing ADHD-RS Inattention subscale score） was significantly greater for patients in the methylphenidate group than in the atomoxetine group with WMD= -1.79 and 95%CI -2.22 to 1.35 （P〈0.000 01）. There was no statistical difference in other outcome measures between two groups （P〉0.05）. Conclusions The effectiveness and tolerance of methylphenidate and atomoxetine are similar in treatment of ADHD. Further large randomized, double blind, placebocontrolled trials with end-point outcome measures in long-term safety and efficacy are needed.