Meta分析阿托西汀治疗儿童注意力缺陷多动障碍的临床疗效  

The efficacy of atomoxetine in treatment of attention-deficit hyperactivity disorder(ADHD)—Meta-analysis of RCT

作　　者：汤亚南[1] 魏玲[1] 赵凤临[1] 

机构地区：[1]北京大学附属第三医院儿科,北京100083

出　　处：《中国实用儿科杂志》2007年第11期864-869,共6页Chinese Journal of Practical Pediatrics

摘　　要：目的评价阿托西汀治疗18岁以下注意缺陷多动障碍(ADHD)患儿的临床疗效。方法2006-09—2006-12在北京大学第三医院儿科应用计算机检索Medline/PubMed(1977～2006)医学数据库、荷兰医学文摘(Embase,1989～2006)和OVID全文数据库、Cochrane系统评价数据库(2006年)、中国学术期刊网全文数据库(CNKI,1994～2006)、中国生物医学文献数据库(CBMdisc,1978～2006)和国家科技图书文献中心,收集阿托西汀治疗儿童ADHD的临床试验,进行质量评价,并对符合纳入标准的研究进行Meta分析。结果共查阅到国内外相关临床研究42篇,纳入随机对照研究14篇,其中国外13篇,国内1篇,均为高质量研究(Jadad评分均≥3分)。其中小剂量组[<1.5mg/(kg.d)]阿托西汀与安慰剂的疗效对比共5篇,患儿1125例;大剂量组[≥1.5mg/(kg.d)]阿托西汀与安慰剂的疗效对比共6篇,患儿1351例;阿托西汀与哌甲酯的临床疗效对比共3篇,患儿446例。合并分析表明,不同剂量阿托西汀与安慰剂相比,均可显著降低患儿ADHD-RS量表的评分(P<0.01),其中小剂量组平均减分值[95%可信限(95%CI)]为[-3.62(-4.51,-2.72)],大剂量组平均减分值(95%CI)为[-5.97(-8.67,-3.27)];阿托西汀与哌甲酯在改善患儿核心症状方面差异无显著性(P=0.31),平均减分值之差(95%CI)为[-1.18(-3.43,1.08)]。结论从现有的临床证据看,阿托西汀在改善18岁以下ADHD患儿的核心症状方面,疗效显著。阿托西汀与哌甲酯尤其是缓释哌甲酯的疗效对比仍需大规模、高质量、随访结局统一的临床试验以进一步验证。Objective To assess the efficacy of atomoxetine in treatment of attention deficit/hyperactivity disorder （ADHD）. Methods According to the requirements of Cochrane systematic review,a thorough literature search was performed among Medline/PubMed （ 1977 - 2006 ） ,Embase （ 1989 - 2006 ） , OVID, Cochrane （ 2006 ） , Chinese Digital Hospital Library （ www. chkd. cnki. net） and Chinese Biomedical Literature Disk Database （CBMdisk）. Quality assessments of clinical trials were carried out. Randomized controlled trials （RCTs） with atomoxetine and ADHD was enrolled for meta-analysis. Results A total of 42 papers met the inclusion criteria. 14 RCTs were included, 13 papers were done in overseas and 1 paper was done in China. In Jadad score, all trials scored over 3. All of the RCTs described the method of randomization, allocation concealment and mentioned whether blindness was used. In the meta-analysis ,hyperactive/impulsive scores of Attention-Deficit/Hyperactivity Disorder Rating Scale were significantly lower for children treated with atomoxetine low dose [ 〈 1.5mg/（ kg·d） ] compared with those treated with placebo （ P 〈 0. 01 ）. Decrease scores from endpoint to baseline [ （95% confidence interval （CI） ] was [ -3.62（ -4. 51, -2. 72） ]. Similar results were observed for the atomoxetine high dose [≥1.5mg/（ kg · d） ]. Decrease scores from endpoint to baseline （95% CI） was [ -5.97 （ 8.67, - 3.27 ） ]. No statistically significant differences between atomoxetine and methylphenidate groups were observed on the core symptoms （ P = 0. 31 ）. Difference between decrease scores from endpoint to baseline （95% CI） was [ - 1.18 （ - 3.43,1.08 ） ]. Conclusion The clinical evidences available so far indicate that atomoxetine treatment appears generally effective in the treatment of children 〈 18ys with ADHD. Well designed RCTs are still needed to evaluate the value between atomoxetine and methylphenidate （ especially extended-release methylphenidate） in t

关 键 词：注意缺陷多动障碍 阿托西汀 儿童 META分析 

分 类 号：R72[医药卫生—儿科]