地牡宁神口服液治疗3~6岁多动症患儿有效性、安全性

目的探究地牡宁神口服液治疗3~6岁多动症患儿临床疗效及安全性,为证实中医药治疗儿童多动症有效性及安全性提供临床依据。方法文章采用自身对照研究,2014年3月-2018年9月,将符合入组标准的3~6岁多动症儿童31人作为研究对象,疗程为24周,以Conners父母用症状问卷(parent symptom questionnaire,PSQ)、中医证候量表及韦氏智力量表评估其疗效,以血生化、血常规、心电图及不良反应发生率评价其安全性。结果在第24周,患儿PSQ在第24周末与治疗前相比,PSQ中各维度评分均较治疗前降低,且除心身障碍维度外[治疗前(0.37±0.29)分,第24周(0.26±0.21)分,Z=-1.490,P=0.140],余差异均具有统计学意义(P<0.05)。中医症候疗效:在第8周、16周、24周,中医证候主、次症积分及总积分均低于治疗前(P<0.05),且总有效率分别为61.29%、80.65%、83.87%。第24周时,韦氏幼儿智力结果显示:总智商,知觉推理、工作记忆、加工速度得分,皆高于基线分,差异具有统计学意义(P<0.05)。血常规、血生化差异皆无统计学意义(P>0.05),治疗前后心电图检查均未有异常发现,不良反应发生率为约13%。结论地牡宁神口服液治疗小儿多动症疗效确切,且不良反应少,安全性高。

An Efficacy and Safety Study on Dimu Ningshen Koufuye Which was Used to Treat Children With Attention Deficit Hyperactivity Disorder at 3~6 Years Old

Objective To explore the clinical efficacy and safety of Dimu Ningshen Koufuye in the treatment of 3~6-year-old children with ADHD.Methods From March 2014 to September 2018,31 hyperactivity children aged 3~6 years who met the enrollment criteria were selected as the study subjects in a self-control study.The course of treatment was 24 weeks.The parents of Conners used the parent symptom questionnaire Questionnaire,PSQ,TCM Syndrome Scale and Wechsler Intelligence Scale were used to evaluate the efficacy,and blood biochemistry,blood routine,ECG and adverse reactions were used to evaluate the safety.Results At the 24 th week,the scores of PSQ in all dimensions of PSQ were lower than those before treatment at the 24 th week,and the other differences were statistically significant(P<0.05),except for the dimension of psychosomatic disorders[(0.37±0.29)points before treatment,(0.26±0.21)points at the 24 th week,z=-1.490,P=0.140].Effect of TCM syndromes:at week 8,16 and 24,the main,secondary and total scores of TCM syndromes were lower than before treatment(P<0.05),and the total effective rates were 61.29%,80.65%and 83.87%,respectively.At week 24,wechsler infant intelligence scores were significantly higher than baseline(P<0.05).There was no significant difference in blood routine test and biochemical test(P>0.05).No abnormality was found in ECG before and after treatment.The incidence of adverse reactions was about 13%.Conclusion Dimu Ningshen Koufuye has definite curative effect on ADHD,less adverse reactions and high safety.