静灵口服液联合盐酸哌甲酯治疗儿童注意缺陷多动障碍有效性和安全性的系统评价

Systematic Review of Efficacy and Safety of Jingling Oral Liquid Combined with Methylphenidate Hydrochloride in the Treatment of Children with Attention Deficit Hyperactivity Disorder

目的:系统评价静灵口服液联合盐酸哌甲酯治疗儿童注意缺陷多动障碍(attention deficit hyperactivity disorder,ADHD)的有效性和安全性,为中药治疗该病提供参考依据。方法:检索the Cochrane Library、Pub Med、EMBase、中国知网、万方数据库以及中国生物医学文献数据库,纳入静灵口服液联合盐酸哌甲酯(研究组)与单纯使用盐酸哌甲酯(对照组)分别治疗儿童ADHD的随机对照试验(randomized controlled trial,RCT),检索时限从建库起至2020年9月。按纳入与排除标准筛选文献、提取资料并评估纳入研究的方法学质量后,采用Rev Man 5.4软件进行荟萃分析(Meta分析)。结果:共7项RCT纳入分析,涉及523例儿童ADHD患者,其中研究组患儿265例,对照组患儿258例;年龄7~15岁;对照组患儿单纯使用盐酸哌甲酯治疗,研究组患儿在对照组基础上加用静灵口服液。结局指标包括多动指数、显效率、总有效率和不良反应。Meta分析结果显示,两组患儿的显效率(RR=1.45,95%CI=1.26~1.72,P<0.01)、总有效率(RR=1.22,95%CI=1.13~1.33,P<0.01)、多动指数(MD=-0.7,95%CI=-8.53~-5.44,P<0.01)和不良反应发生率(RR=0.33,95%CI=0.17~0.64,P<0.01)比较,差异均有统计学意义,研究组患儿均优于对照组。结论:静灵口服液联合盐酸哌甲酯治疗儿童ADHD的有效性和安全性均高于单纯使用盐酸哌甲酯。

OBJECTIVE:To systematically evaluate the efficacy and safety of Jingling oral liquid combined with methylphenidate hydrochloride in the treatment of children with attention deficit hyperactivity disorder(ADHD),so as to provide reference for the treatment of the disease with traditional Chinese medicine.METHODS:The Cochrane Library,PubMed,EMBase,CNKI,Wanfang database and CMB were retrieved to collect the randomized controlled trial(RCT)of Jingling oral liquid combined with methylphenidate hydrochloride(study group)and methylphenidate hydrochloride alone(control group)in the treatment of children with ADHD.The retrieval time was from the establishment of the database to Sept.2020.After screening the literature according to the inclusion and exclusion criteria,extracting the data and evaluating the methodological quality of the included literature,RevMan 5.4 software was used for Meta-analysis.RESULTS:A total of 7 RCT were included,including 523 children with ADHD aged from7 to 15 years old,with 265 cases in the study group and 258 cases in the control group.The control group was treated with methylphenidate hydrochloride alone,while the study group received Jingling oral liquid on the basis of the control group.Outcome indicators included conners index of hyperactivity,significant efficiency,total efficiency and adverse drug reactions were analyzed.Meta-analysis results showed that the significant efficiency(RR=1.45,95%CI=1.26-1.72,P<0.01),total efficiency(RR=1.22,95%CI=1.13-1.33,P<0.01),conners index of hyperactivity(MD=-0.7,95%CI=-8.53--5.44,P<0.01)and adverse drug reactions(RR=0.33,95%CI=0.17-0.64,P<0.01)were statistically significantly different between two groups,and the study group was higher than the control group.CONCLUSIONS:The efficacy and safety of Jingling oral liquid combined with methylphenidate hydrochloride in the treatment of children with ADHD are higher than that of methylphenidate hydrochloride alone.