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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 evaluate the clinical efficacy of atomoxetine in children under 18 years of age with attention deficit hyperactivity disorder (ADHD). Methods From September 2006 to December 2006, Pedline Department of Pediatrics, Peking University Third Hospital was used to search the Medline / PubMed (1977 ~ 2006) medical databases, Embase (1989 ~ 2006) and OVID full - text databases, Cochrane Database (2006 Year), CNKI (from 1994 to 2006), CBMdisc (1978 ~ 2006) and National Science and Technology Library and Information Center, clinical trials of atomoxetine in children with ADHD were collected, Evaluation, and Meta-analysis of studies that met the inclusion criteria. Results A total of 42 clinical studies were reviewed at home and abroad, including 14 randomized controlled studies, of which 13 were in foreign countries and 1 was in domestic. All were high quality studies (Jadad score ≥3). Among them, the efficacy of low dose group [<1.5mg / (kg · d)] of atomoxetine and placebo was compared with 5 articles in 1125 children; the high dose group [≥1.5mg / (kg · d) Xetin and placebo efficacy comparison of a total of 6 articles, 1351 cases of children; the clinical efficacy of atomoxetine and methylphenidate in a total of 3 articles, 446 cases of children. The pooled analysis showed that all doses of atomoxetine significantly reduced the ADHD-RS score (P <0.01) in children compared with placebo, with an average reduction score of 95% confidence interval (95% confidence interval 95% CI) was -3.62 (-4.51, -2.72), and the average reduction score (95% CI) was -5.97 (-8.67, -3.27) in the high-dose group. There was no significant difference (P = 0.31) between the two groups in improving the core symptoms of children. The mean difference (95% CI) between the two groups was [-1.18 (-3.43,1.08)]. Conclusion From the available clinical evidence, atomoxetine has a significant effect in improving the core symptoms of children under 18 years of age with ADHD. The comparative efficacy of atomoxetine and methylphenidate, especially sustained-release methylphenidate, still requires large-scale, high-quality, and uniform follow-up clinical trials for further validation.