山东医药2025,Vol.65Issue(4):63-67,5.DOI:10.3969/j.issn.1002-266X.2025.04.013
基于ChiCTR数据库的注意缺陷多动障碍临床试验注册现状分析
Analysis of current status of clinical trial registrations for ADHD in China based on ChiCTR database
摘要
Abstract
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.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Key words
attention deficit hyperactivity disorder/Chinese Clinical Trial Registry/clinical trial/traditional Chi-nese medicine treatment分类
医药卫生引用本文复制引用
赵赛,赵书羽,王正,陈自佳..基于ChiCTR数据库的注意缺陷多动障碍临床试验注册现状分析[J].山东医药,2025,65(4):63-67,5.基金项目
国家自然科学基金项目(82205191) (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). (2022-SZ-C-89)