中成药治疗儿童注意缺陷多动障碍疗效和安全性的系统评价

Efficacy and Safety of Chinese Patent Medicines in Treatment of Attention Deficit Hyperactivity Disorder in Children:A Systematic Review

目的系统评价中成药治疗儿童注意缺陷多动障碍的疗效和安全性。方法检索中国知网、万方数据库、维普网、中国生物医学文献服务系统、PubMed、Cochrane Library、PsycINFO、Embase中所有关于中成药治疗儿童注意缺陷多动障碍的随机对照试验。根据预先设定的标准由两名研究者独立筛选,使用Review Manager 5.3软件进行纳入研究的偏倚风险评估和Meta分析。结果最终23项研究共2314个对象被纳入数据分析,未发现中成药与安慰剂比较的研究。中成药组与哌甲酯组的总有效率比较,差异无统计学意义(RR=1.06,95%CI为0.99~1.13,P=0.08),但中成药组的不良反应总发生率低于哌甲酯组,差异有统计学意义(RR=0.14,95%CI为0.08~0.24,P<0.00001)。中成药联合哌甲酯组总有效率高于哌甲酯组,差异有统计学意义(RR=1.17,95%CI为1.07~1.29,P=0.0005);两组不良反应总发生率的差异无统计学意义(RR=0.53,95%CI为0.24~1.17,P=0.11)。结论中成药治疗儿童注意缺陷多动障碍疗效良好且不良反应少,但仍需要设计更合理的高质量随机对照研究,尤其是与安慰剂对照的研究来证实。

Objective To systematically review the efficacy and safety of Chinese patent medicines(CPMs)in the treatment of attention deficit hyperactivity disorder(ADHD)in children.Methods CNKI,Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,PsycINFO,and Embase were searched for randomized controlled trials(RCTs)on CPMs in the treatment of ADHD in children.Two independent investigators screened the studies according to pre-specified criteria,and Review Manager 5.3 was used to assess the risk of bias of included studies and perform the meta-analysis.Results A total of 23 RCTs were included,with 2314 subjects in total,and there were no studies on the comparison of CPMs and placebo.There was no significant difference in overall response rate between the CPM group and the methylphenidate group[risk ratio(RR)=1.06,95%confidence interval(CI):0.99-1.13,P=0.08)],but the CPM group had a significantly lower overall incidence rate of adverse events than the methylphenidate group(RR=0.14,95%CI:0.08-0.24,P<0.00001).The CPM+methylphenidate group had a significantly higher overall response rate than the methylphenidate group(RR=1.17,95%CI:1.07-1.29,P=0.0005)and there was no significant difference in the overall incidence rate of adverse events between the two groups(RR=0.53,95%CI:0.24-1.17,P=0.11).Conclusion CPMs have good efficacy and few adverse effects in the treatment of ADHD in children,which needs to be verified by more reasonable RCTs with high quality,especially randomized placebo-controlled studies.