地牡宁神口服液治疗儿童ADHD有效性、安全性

目的研究地牡宁神口服液治疗儿童注意缺陷多动障碍(attentiondeficit/hyperactivity disorder,ADHD)的临床疗效、安全性,为证实中医药治疗儿童ADHD有效性、安全性提供依据。方法将2014年3月—2018年9月符合入组标准的ADHD儿童126例,采用随机对照临床试验设计,分为地牡宁神口服液组(研究组)64例,哌甲酯控释片组(methylphenidate,MPH对照组)62例,疗程为24周,以Swanson儿童行为量表第4版(version of Swanson Nolan and Pelham,Version IV Scale-parent form,SNAP-IV)、中医证候量表评估其疗效,以血生化、心电图(ECG)评价安全性。结果两组儿童SNAP-IV总积分、治疗后各时点积分比较,在第8周时研究组高于对照组(P<0.05);研究组第8周、16周、24周的有效率分别为42.2%、67.2%、73.4%,对照组有效率分别为61.3%、66.1%、71.0%。中医证候疗效比较,研究组控显率为43.7%,总有效率为78.1%;对照组控显率为21.0%,总有效率为64.5%,研究组中医证候疗效优于对照组(P<0.05)。两组在血生化检查方面,治疗前后组内比较,差异无统计学意义(P>0.05);心电图变异率及不良反应发生率,两组组间比较,差异无统计学意义(P>0.05)。结论地牡宁神口服液在改善ADHD儿童核心症状方面,长期疗效与MPH相当,且不良反应少,安全性更高。

An Efficacy and Safety Study on Dimu Ningshen Koufuye Which was Used to Treat Children With Attention Deficit Hyperactivity Disorder

Objective To study the clinical efficacy and safety of Dimu Ningshen Koufuye in the treatment of children's attentiondeficit/hyperactivity disorder(ADHD),and to provide evidence for the effectiveness and safety of traditional Chinese medicine in the treatment of ADHD in children.Methods 126 children with ADHD into the standard set from march 2014 to September 2018,randomized controlled clinical trial design,divided into Dimu Ningshen Koufuye group(research group),64,and methylphenidate group(MPH control group),62 people,treatment for 24 weeks.The version IV Scale-parent form and TCM syndrome scale were used to evaluate its efficacy,and blood biochemistry and electrocardiogram(ECG)were used to evaluate its safety.Results The total score of SNAPIV in the two groups was higher than that in the control group(P<0.05).The effective rates at week 8,week 16 and week 24 were 42.2%,67.2% and 73.4% in the study group,and 61.3%,66.1% and 71.0% in the control group.The control rate of TCM syndromes in the study group was 43.7%,and the total effective rate was 78.1%.In the control group,the control rate was 21.0%,the total effective rate was 64.5%,and the effect of TCM syndromes in the study group was better than that in the control group(P<0.05).In terms of blood biochemical examination,there was no significant difference between the two groups before and after treatment(P>0.05).There was no significant difference between the two groups(P>0.05).Conclusion In improving the core symptoms of ADHD children,Dimu Ningshen oral solution has the same long-term efficacy as MPH,with less adverse reactions and higher safety.