中医药治疗儿童注意缺陷多动障碍的临床研究证据图谱分析

Evidence mapping of clinical research on traditional Chinese medicine interventions for attention deficit hyperactivity disorder in children

关键词:  中医药  注意缺陷多动障碍  证据图  临床研究  随机对照试验

Key words:  traditional Chinese medicine  attention deficit hyperactivity disorder  evidence map  clinical study  randomized controlled trials

摘要:

[目的] 运用证据图谱系统分析中医药治疗注意缺陷多动障碍（ADHD）的临床研究现状。[方法] 计算机检索PubMed、Web of Science、Cochrane Library、EMbase、PsycINFO、中国知网、万方数据知识服务平台、维普网、SinoMed数据库。检索从建库至2025年1月中医药治疗ADHD的相关研究。采用Cochrane手册的风险偏倚评估工具、AMSTAR 2、AGREEⅡ分别对纳入的随机对照试验（RCTs）、系统评价/Meta分析和专家共识/指南进行质量评价。采用文字结合折线图、气泡图、条形堆积图、三线表等形式呈现临床研究证据分布特征。[结果] 1）研究热度在2005年达到峰值后呈波动下降趋势，近年来有所回升，趋于历史高峰水平。样本量集中在51~100例。RCTs和non-RCTs的干预周期分别以8~12周和4~8周为主。2）热点干预措施集中于单纯中药口服（59.2%），高频干预措施为中药复方（50.0%）。高频运用经方为甘麦大枣汤（46.2%）、高频运用时方为六味地黄丸和归脾汤（均为15.2%）。核心证型以肝肾阴虚证（19.8%）、心脾两虚证（19.0%）为主。3）结局指标偏重临床疗效与中医证候评估，而在主要及次要指标区分、功能损害及共病情况、量表使用及报告规范、经济学评价指标等方面关注不足。4）方法学质量亟待提升，RCTs因随机化方法、分配隐藏及盲法实施等方面存在问题而偏倚风险较高，Meta分析/系统评价主要在研究前方案注册、文献排除清单及原因、纳入研究资金来源及利益冲突等方面存在问题，专家共识/指南在制定严谨性、应用性、编辑独立性等方面存在不足。[结论] 中医药治疗ADHD具有一定优势，但现有研究质量普遍不高。未来临床研究需着眼于顶层设计，规范并优化研究内容，提高研究质量，充分挖掘中医药治疗优势，为中医药治疗ADHD提供更高级别的循证证据。

Abstract:

[Objective] To systematically analyze the current status of clinical research on traditional Chinese medicine treatment for attention deficit hyperactivity disorder（ADHD） using an evidence map. [Methods] Computerized searches were conducted in PubMed，Web of Science，Cochrane Library，EMbase，PsycINFO，CNKI，Wanfang，VIP，and SinoMed databases. Relevant studies on traditional Chinese medicine treatment for ADHD were retrieved from the inception of each database to January 2025. Quality assessments were conducted using the Cochrane Handbook risk of bias tool，AMSTAR 2，and AGREE Ⅱ for included randomized controlled trials，systematic reviews/meta-analyses，and guidelines/expert consensus statements，respectively. Evidence distribution patterns from clinical studies are presented using text combined with line charts，bubble charts，stacked bar charts，and three-line tables. [Results] 1）Research interest in traditional Chinese medicine treatment for ADHD peaked in 2005 before showing a fluctuating decline，with a recent resurgence approaching historical highs. Study sample sizes predominantly ranged from 51 to 100 cases，while intervention durations for randomized controlled trials（RCTs） and non-RCTs primarily spanned 8 to 12 weeks and 4 to 8 weeks，respectively. 2） The most frequently used intervention was oral administration of single Chinese herbal medicines（59.2%），while compound Chinese herbal formulas were the most frequently used intervention（50.0%）. The most frequently used classical formula was Ganmai Dazao Tang（46.2%），while the most frequently used contemporary formulas were Liuwei Dihuang Wan and Guipi Tang（both 15.2%）. Core syndrome patterns primarily included liver-kidney yin deficiency（19.8%） and heart-spleen deficiency（19.0%）. 3） Outcome measures predominantly assessed clinical efficacy and traditional Chinese medicine syndrome evaluation，with insufficient attention to primary/secondary outcome differentiation，functional impairment and comorbidities，scale application and reporting standards，and economic evaluation indicators. 4） Methodological quality urgently requires improvement：RCTs exhibited high risk of bias due to issues in randomization methods，allocation concealment，and blinding implementation；Meta-analyses/systematic reviews primarily had problems in pre-registration of study protocols，exclusion criteria and justifications，funding sources of included studies，and conflicts of interest；expert consensus/guidelines showed deficiencies in formulation rigor，applicability，and editorial independence. [Conclusion] Future clinical studies need to focus on top-level design，standardize and optimize research protocols，improve research quality，fully explore the therapeutic advantages of traditional Chinese medicine，and provide higher-level evidence-based evidence for the treatment of ADHD with traditional Chinese medicine.