龙牡清心合剂治疗儿童注意缺陷多动障碍临床疗效及安全性评价

Clinical efficacy and safety evaluation of Longmu Qingxin mixture in the treatment of children with attention deficit hyperactivity disorder

关键词:  注意缺陷多动障碍  龙牡清心合剂  临床疗效  安全性

Key words:  attention deficit hyperactivity disorder  Longmu Qingxin mixture  clinical efficacy  security

摘要:

[目的] 评价龙牡清心合剂治疗儿童注意缺陷多动障碍（ADHD）的临床疗效及安全性。[方法] 本研究采用随机信封法将100名ADHD患儿随机分为对照组和治疗组，每组各50例。对照组予以盐酸哌甲酯控释片口服，治疗组在对照组基础上联合龙牡清心合剂口服，疗程均为12周。比较两组患儿治疗前后注意缺陷多动障碍筛查量表（SNAP-Ⅳ）、Conners父母症状问卷（PSQ）和Weiss功能缺陷量表-父母版（WFIRS-P）评分，评估两组患儿中医证候疗效，并进行安全性评价。[结果] 1）SNAP-Ⅳ核心症状评分：治疗4周时，治疗组患儿的注意缺陷、多动/冲动得分较对照组明显降低（P<0.05）；治疗12周时，治疗组患儿的注意缺陷、多动/冲动和对立违抗得分均明显低于对照组（P<0.05）。2）PSQ行为能力评分：治疗4周时，治疗组患儿的学习问题及冲动/多动得分较对照组明显降低（P<0.05）；治疗12周时，治疗组患儿的品行问题、学习问题、身心问题和冲动/多动得分均明显低于对照组（P<0.05）。3）WFIRS-P社会功能评分：治疗12周时，治疗组患儿家庭、学习学校、生活技能得分明显低于对照组（P<0.05）。4）中医证候疗效：治疗结束时治疗组总有效率为90.00%，对照组总有效率为72.00%，治疗组明显优于对照组（P＜0.05）。5）安全性评价：治疗期间及治疗结束后两组患儿均未出现试验相关的严重不良反应。[结论] 龙牡清心合剂可改善ADHD患儿的核心症状、行为能力和社会功能，中医证候疗效显著，且安全性较好。

Abstract:

[Objective] To evaluate the clinical efficacy and safety of Longmu Qingxin mixture in the treatment of children with attention deficit hyperactivity disorder（ADHD）. [Methods] In this study，the random envelope method was employed to allocate 100 children diagnosed with ADHD into two groups：a control group and a treatment group，each comprising 50 participants. The control group received treatment with methylphenidate hydrochloride controlled-release tablets，whereas the experimental group was administered the Longmu Qingxin mixture in addition to the regimen provided to the control group. The duration of the treatment was 12 weeks. The scores of attention deficit hyperactivity disorder screening scale（SwansonNolan，and Pelham-Ⅳ rating scales，SNAP-Ⅳ），Conners’ parent symptom questionnaire（PSQ） and Weiss functional impairment rating scales parent report（WFIRS-P） were compared between the two groups before and after treatment. The curative effect of traditional Chinese medicine（TCM） syndrome in the two groups was evaluated，and the safety was evaluated. [Results] 1） SNAP-Ⅳ core symptom score：after 4 weeks of treatment，the treatment group had significantly lower attention deficit and hyperactivity/impulsivity scores than the control group（P<0.05）；after 12 weeks of treatment，the treatment group had significantly lower scores for attention deficit，hyperactivity/impulsivity，and oppositional defiance compared to the control group（P<0.05）. 2） PSQ behavioral ability score：after 4 weeks of treatment，the treatment group had significantly lower scores for learning problems and impulsivity/hyperactivity compared to the control group（P<0.05）；after 12 weeks of treatment，the treatment group had significantly lower scores in conduct，learning，physical，mental，and impulsivity/hyperactivity problems compared to the control group（P<0.05）. 3） WFIRS-P social function score：after 12 weeks of treatment，the treatment group had significantly lower scores in family，school，and life skills compared to the control group（P<0.05）. 4） TCM syndrome efficacy：at the end of treatment，the total effective rate of the treatment group was 90.00%，and that of the control group was 72.00%，which was significantly better than that of the control group（P<0.05）. 5） Safety evaluation：neither group of children had serious adverse reactions during or after the treatment. [Conclusion] Longmu Qingxin mixture can improve the core symptoms，behavioral ability and social function of children with ADHD，and the curative effect of TCM syndrome is significant，and the safety is good.