清心平肝定志方联合哌甲酯治疗心肝火旺证注意力缺陷多动障碍患者的疗效观察

Clinical Efficacy of Qingxin Pinggan Dingzhi Formula Combined with Methylphenidate in the Treatment of Attention Deficit Hyperactivity Disorder with Heart-Liver Fire Blazing Syndrome

目的 探讨清心平肝定志方联合哌甲酯治疗心肝火旺证注意力缺陷多动障碍(Attention deficit hyperactivity disorder,ADHD)的临床疗效。方法 选取2019年6月—2021年12月期间湖北省中医院儿科收治的138例ADHD患者,按随机数字表法分为对照组与试验组,每组69例。对照组给予盐酸哌甲酯控释片治疗,试验组在此基础上联合中医清心平肝定志方治疗,两组患儿均治疗8周。观察比较两组患儿西医疾病疗效、中医证候疗效、安全性,治疗前后注意缺陷多动障碍评估量表(SonNolanandPelham,VersionIVScale-parentform,SNAP-IV,SNAP-Ⅳ)评分、中医证候积分(任性冲动、多语多动、急躁易怒、好惹扰人、做事莽撞、神思涣散、语声高亢、面红目赤、小便色黄、大便秘结)及血清单胺类神经递质[去甲肾上腺素(Norepinephrine,NE)、5-羟色胺(5-hydroxytryptamine,5-HT)、多巴胺(Dopamine,DA)]、丘脑-垂体-肾上腺(Hypotha-lamic-pituitary-adrenal axis,HPA)轴指标[皮质醇(Cortisol,COR)、促肾上腺皮质激素(Adrenocorticotropic hormone,ACTH)]水平变化。结果 (1)西医疾病疗效:试验组西医疾病疗效总有效率92.75%(64/69)明显高于对照组79.10%(53/67),差异有统计学意义(P<0.05)。(2)中医证候疗效:试验组中医证候疗效总有效率89.86%(62/69)明显高于对照组67.16%(45/67),差异有统计学意义(P<0.05)。(3)疾病评分:治疗后两组患儿SNAP-Ⅳ多动/冲动症状、注意力缺陷症状各维度评分均较治疗前降低,差异有统计学意义(P<0.05);且试验组SNAP-Ⅳ多动/冲动症状、注意力缺陷症状各维度评分低于对照组,差异有统计学意义(P<0.05)。(4)中医证候积分:治疗后两组患儿各中医证候积分均较治疗前降低,差异有统计学意义(P<0.05);且试验组各中医证候积分低于对照组,差异有统计学意义(P<0.05)。(5)单胺类神经递质:治疗后两组患儿血清NE、5-HT、DA水平均较治疗前升高,差异有统计学意义(P<0.05);且试验组血清NE、5-HT、DA水平高于对照组,差异有统计学意义(P<0.05)。(6)HPA轴指标:治疗后两组患儿血清COR、ACTH水平均较治疗前升高,差异有统计学意义(P<0.05);且试验组血清COR、ACTH水平高于对照组,差异有统计学意义(P<0.05)。(7)安全性:两组患儿不良反应发生率比较,差异无统计学意义(P>0.05)。结论 清心平肝定志方联合哌甲酯治疗ADHD安全、有效,有利于改善患者注意力缺陷与多动/冲动症状,且可能与上调单胺类神经递质水平、调控HPA轴功能有关。

Objective To investigate the clinical efficacy of Qingxin Pinggan Dingzhi Formula combined with methylphenidate in treating attention deficit hyperactivity disorder(ADHD)with heart-liver fire blazing syndrome.Methods A total of 138 ADHD patients treated at the Department of Pediatrics,Hubei Provincial Hospital of Traditional Chinese Medicine between June 2019 and December 2021 were enrolled and divided into a control group and an experimental group using a random number table method,with 69 patients in each group.The control group received treatment with methylphenidate hydrochloride controlled-release tablets,while the experimental group received Qingxin Pinggan Dingzhi Formula on the basis of the treatment protocol of the control group.Both groups were treated for eight weeks.The western medicine therapeutic efficacy,traditional Chinese medicine(TCM)syndrome efficacy,and safety were observed and compared between the two groups.The changes in the Attention Deficit/Hyperactivity Disorder Rating Scale(SNAP-IV),traditional Chinese medicine syndrome scores(impulsivity,hyperactivity,irritability,restlessness,recklessness,scattered thoughts,high-pitched speech,red face and eyes,yellow urine,and constipation),serum monoamine neurotransmitters[norepinephrine(NE),5-hydroxytryptamine(5-HT),and dopamine(DA)],and hypothalamic-pituitary-adrenal(HPA)axis indicators[cortisol(COR)and adrenocorticotropic hormone(ACTH)]of the two groups were evaluated before and after treatment.Results(1)Western medicine therapeutic efficacy:The total effective rate in the experimental group was 92.75%(64/69),significantly higher than 79.10%(53/67)in the control group(P<0.05).(2)TCM syndrome efficacy:The total effective rate in the experimental group was 89.86%(62/69),significantly higher than 67.16%(45/67)in the control group(P<0.05).(3)Disease scores:After treatment,the SNAP-IV scores for impulsivity/hyperactivity and inattention decreased in both groups(P<0.05).The experimental group had lower SNAP-IV scores for impulsivity/hyperactivity and inattention than the control group(P<0.05).(4)TCM syndrome scores:After treatment,the TCM syndrome scores decreased in both groups(P<0.05).The experimental group had lower TCM syndrome scores than the control group(P<0.05).(5)Monoamine neurotransmitters:After treatment,serum NE,5-HT,and DA levels increased in both groups(P<0.05).The experimental group had higher serum NE,5-HT,and DA levels than the control group(P<0.05).(6)HPA axis indicators:After treatment,serum COR and ACTH levels increased in both groups(P<0.05).The experimental group had higher serum COR and ACTH levels than the control group(P<0.05).(7)Safety:There was no statistically significant difference in the incidence of adverse reactions between the two groups(P>0.05),and treatment was not affected.Conclusion Qingxin Pinggan Dingzhi Formula combined with methylphenidate for treating ADHD is safe and effective,which can improve symptoms of inattention and impulsivity/hyperactivity.The mechanism may be associated with upregulating monoamine neurotransmitter levels and regulating HPA axis function.