摘要
目的分析中国临床试验注册中心(ChiCTR)数据库中注意缺陷多动障碍(ADHD)相关临床试验的注册现状,探讨其发展趋势及存在的问题,为未来ADHD研究提供参考。方法系统检索ChiCTR数据库,收集自建库起至2024年11月30日所有ADHD相关临床试验注册信息,分析其在注册时间、诊断标准、干预措施、试验设计、地区分布等方面的特点。结果共纳入128项ADHD相关临床试验。试验注册量自2010年首次注册以来稳步上升,2020年后年注册量达10项以上。注册地区主要集中在较发达地区(北京31项、上海15项、广东15项),欠发达地区研究较少。诊断标准以DSM-5为主(71.88%),且2023年后DSM-5使用率进一步提高。干预措施以非药物干预为主(50.78%),包括行为训练、运动干预等;药物干预比例为15.63%。试验设计以随机平行对照最常见(47.66%),仅14.29%的干预性试验采用双盲设计。中医药干预研究仅占10.16%,特色不显著。结论我国ADHD相关临床试验注册量稳步增长、诊断标准逐渐统一、干预措施呈现多样化,但也存在盲法实施不足、地区分布不均衡及中医药研究不足等问题。
Objective To analyze the current status of registered clinical trials related to Attention Deficit Hyperac-tivity Disorder(ADHD)in the Chinese Clinical Trial Registry(ChiCTR)database,and to explore their development trends and existing issues,so as to provide references for future ADHD research.Methods The ChiCTR database was systematically searched to collect all registered ADHD-related clinical trials from its inception to November 30,2024.Characteristics including registration timeline,diagnostic criteria,interventions,trial design,and regional distribution were analyzed.Results A total of 128 ADHD-related clinical trials were included.Trial registrations increased steadily since the first registration in 2010,with annual registrations exceeding 10 after 2020.Registrations were concentrated in more developed regions(Beijing:31 trials,Shanghai:15 trials,Guangdong:15 trials),while underdeveloped regions had fewer studies.The predominant diagnostic criterion was the DSM-5(71.88%),with its usage further increasing after 2023.Non-pharmacological interventions dominated(50.78%),including behavioral training and exercise interventions,while pharmacological interventions accounted for 15.63%.The most common trial design was randomized parallel-con-trolled(47.66%),with only 14.29%of interventional trials adopting a double-blind design.Studies on traditional Chi-nese medicine interventions were limited(10.16%),lacking distinctive features.Conclusions ADHD-related clinical trial registrations in China have shown steady growth,the diagnostic criteria have been gradually unified,and the interven-tion measures have shown diversification.However,challenges remain,including insufficient implementation of blinding methods,uneven regional distribution,and limited research on traditional Chinese medicine interventions.
作者
赵赛
赵书羽
王正
陈自佳
ZHAO Sai;ZHAO Shuyu;WANG Zheng;CHEN Zijia(The Second Clinical Medical College,Beijing University of Chinese Medicine,Beijing 100078 China;不详)
出处
《山东医药》
2025年第4期63-67,共5页
Shandong Medical Journal
基金
国家自然科学基金项目(82205191)
北京中医药薪火传承“3+3”工程王素梅名医传承工作站项目(2022-SZ-C-89)。
关键词
注意缺陷多动障碍
中国临床试验注册中心
临床试验
中医药治疗
attention deficit hyperactivity disorder
Chinese Clinical Trial Registry
clinical trial
traditional Chi-nese medicine treatment
