盐酸托莫西汀治疗儿童注意缺陷多动障碍疗效与安全性的系统评价

摘要

Objective:To assess the efficacy and safety of atomoxetine hydrochloride in the treatment of attention deficit hyperactivity disorder( ADHD).Methods: 7 comparative studies of tomoxetine hydrochloride in the treatment of ADHD were analyzed by Meta-analysis.Results:A total of 7 RCTs were included.The sample size was 1304 patients.Results of Meta-analysis showed that the im-provement of ADHD-RS[MD=-5.86,95%CI( -7.73,-3.99),P<0.00001]、ADHD-RS hyperactivity/impulsive[MD=-2.64, 95%CI(-3.75,-1.52),P<0.00001],ADHD-RS inattention[MD=-2.35,95%CI( -3.87,-0.83),P<0.00001]in atomoxetine hydrochloride group were significantly greater than in control group.The incidence of abdominal pain,nausea,somnolence,decreased appe-tite and vomiting in atomoxetine group were higher than in control group ( P<0.05).Conclusion:Atomoxetine is effective in the treat-ment of children with ADHD and can improve hyperactivity/impulsivity and attention deficit in children with ADHD.But the side effects of them should be considered.%目的：探讨盐酸托莫西汀治疗儿童注意缺陷多动障碍（ ADHD）的疗效和安全性。方法：计算机检索相关医学数据库，采用Meta分析对7项盐酸托莫西汀与安慰剂对比治疗ADHD对照研究的文献进行分析。结果：本研究纳入7篇文献，均为国外文献（ Jadad评分≥3分）；样本含量为1304例；Meta分析结果显示，治疗后盐酸托莫西汀组的注意缺陷／多动评定量表（ ADHD-RS）总分值[MD ＝－5.86，95％CI（－7.73，－3.99），P＜0.00001]、ADHD-RS多动／冲动分量表分值[MD ＝－2.64，95％CI （－3.75，－1.52），P＜0.00001]、ADHD-RS注意缺陷分量表分值[MD＝－2.35，95％CI（－3.87，－0.83），P＜0.00001]改善均显著优于对照组，两组比较有显著性差异；盐酸托莫西汀组患儿比对照组更容易发生腹痛、恶心、呕吐、嗜睡和食欲减退等不良反应（ P＜0.05）。结论：盐酸托莫西汀治疗儿童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，但应注意其不良反应。