摘要目的:评价自拟清心补气平肝汤联合盐酸托莫西汀胶囊治疗注意缺陷多动障碍（ADHD）的疗效。方法:随机对照试验设计。选取2020年1月－2022年1月本院200例ADHD患儿作为观察对象，采用随机数字表法分为2组，每组100例。对照组口服盐酸托莫西汀胶囊，观察组在对照组基础上服用自拟清心补气平肝汤。2组均连续治疗3个月。分别于治疗前后进行中医症状评分，采用斯诺佩评定量表（SNAP-Ⅳ）评估患儿核心症状，Conners父母症状问卷（PSQ）评估患儿多动症倾向；采用化学发光免疫法测定血清皮质醇（COR）、促肾上腺皮质激素（ACTH）水平。观察治疗期间的不良反应，评价临床疗效。结果:观察组总有效率为97.0%（97/100）、对照组为88.0%（88/100），2组比较差异有统计学意义（ χ2=5.84， P=0.016）。观察组治疗后心神不宁、多动不安、意志不坚、形体消瘦、面色无华、睡眠不实积分低于对照组（ t值分别为17.90、11.79、10.01、23.27、11.79、12.03， P<0.01）；冲动因子、学习因子、多动因子、行为因子、身心因子、焦虑因子评分低于对照组（ t值分别为4.65、42.83、10.01、41.89、39.42、18.30， P<0.01）；注意缺陷、多动-冲动、行为表现评分低于对照组（ t值分别为11.68、9.69、28.42， P<0.01）。观察组治疗后血清COR［（337.26±17.22）nmol/L比（275.51±15.49）nmol/L， t=26.66］、ACTH［（24.47±1.12）ng/L比（19.23±1.43）ng/L， t=28.85］水平高于对照组（ P<0.01）。治疗期间，观察组不良反应发生率为6.0%、对照组为5.0%，2组比较差异无统计学意义（ χ2=0.10， P=0.756）。 结论:自拟清心补气平肝汤联合盐酸托莫西汀胶囊可改善ADHD患儿的临床症状，降低多动症程度，升高血清COR、ACTH水平，提高临床疗效。

abstractsObjective:To evaluate the efficacy of modified self-made Qingxin Buqi Pinggan Decoction combined with atomoxetine hydrochloride in the treatment of attention deficit hyperactivity disorder (ADHD).Methods:Randomized controlled trial. A total of 200 children with ADHD admitted to our hospital from January 2020 to January 2022 were selected as observation subjects by prospective cohort study, and were divided into two groups according to the random number table method. The control group was given oral administration of atomoxetine hydrochloride capsules, and the observation group was given self-made Qingxin Buqi Pinggan Decoction on the basis of the control group. Both groups were treated continuously for 3 months. Before and after treatment, the Traditional Chinese Medicine symptoms were scored, and the core symptoms of the children were evaluated by Swanson Nolan and Pelham-versionⅣ (SNAP-Ⅳ), and the hyperactivity tendency was assessed by Parent Symptom Questionnaire (PSQ). The serum cortisol (COR) and adrenocorticotropic hormone (ACTH) levels were measured by chemiluminescence immunoassay. Adverse reactions during treatment were observed and clinical efficacy was evaluated.Results:The total effective rate was 97.0% (97/100) in observation group and 88.0% (88/100) in control group ( χ2=5.84, P=0.016). After treatment, the scores of restlessness, hyperactivity, unsteadiness, emaciation, lusterless complexion and restless sleep in the observation group were significantly lower than those in the control group ( t=17.90, 11.79, 10.01, 23.27, 11.79, 12.03, P<0.01). The scores of impulsivity factor, learning factor, hyperactivity factor, behavior factor, psychosomatic factor and anxiety factor were significantly lower than those in the control group ( t=4.65, 42.83, 10.01, 41.89, 39.42, 18.30, P<0.01). The scores of attention deficit, hyperactivity-impulsivity and behavior performance were significantly lower than those in the control group ( t=11.68, 9.69, 28.42, P<0.01). After treatment, the levels of serum COR [(337.26±17.22) nmol/L vs. (275.51±15.49) nmol/L, t=26.66] and ACTH [(24.47±1.12) ng/L vs. (19.23±1.43) ng/L, t=28.85] were significantly higher in observation group than those in the control group ( P<0.01). During treatment, the incidence rate of adverse reactions was 6.0% in observation group and 5.0% in control group ( χ2=0.10, P=0.756). Conclusion:Modified self-made Qingxin Buqi Pinggan Decoction combined with atomoxetine hydrochloride can improve the clinical symptoms of children with ADHD, reduce the degree of hyperactivity disorder, increase the levels of serum COR and ACTH, and enhance the clinical efficacy.