摘要
目的分析国内外中医药防治桥本甲状腺炎(HT)相关临床试验的研究方案,为中医药治疗HT后续研究提供参考。方法检索中国临床试验注册中心、国际传统医学临床试验注册中心及WHO国际临床试验注册中心建库至2024年12月31日中医药防治HT的临床研究注册方案,采用Excel 2019、GraphPad Prism 9.0进行数据处理并对注册试验的基本特征、研究类型、随机方法、干预措施、结局指标等注册信息进行频数分析。结果共纳入注册研究31项,自2018年起注册研究数目渐增;截至2024年已涉及8个省级行政区的23个临床机构,其中注册数量最多的地区为上海(14项);经费来源主要为地方财政资助、医院经费资助,研究类型以干预性研究(30项)为主,设计方案主要为随机平行对照研究(27项)。结论中医药防治HT相关临床试验注册数量整体偏少,但近年受重视程度有所提高,现有试验注册地区分布不均衡,研究设计方案亦需完善。
ObjectiveTo analyze the research programs of clinical trials related to the TCM treatment of Hashimoto's thyroiditis(HT)at home and abroad;To provide references for the follow-up study of TCM treatment of HT.MethodsAll clinical research registration plans for TCM prevention and treatment of HT were retrieved from the Chinese Clinical Trial Registry,the International Traditional Medicine Clinical Trial Registry,and the WHO International Clinical Trial Registration Platform from the establishment of the databases to December 31,2024.Excel 2019 and GraphPad Prism 9.0 were used for data processing,and the basic characteristics,study types,randomized methods,interventions,outcome indicators and other registration information of registered trials with the frequency analysis.ResultsA total of 31 clinical trials were included in this study,and the number of registered studies has gradually increased since 2018,which involving 23 clinical institutions in 9 provincial-level administrative regions until 2024.The region with the highest number of registrations is Shanghai(14 items).The funding sources were mainly local financial support and hospital funding.The research types were mostly intervention studies(30 items).The main research design type was randomized parallel controlled trials(27 items).ConclusionsAt present,the overall number of registration studies on TCM prevention and treatment of HT is relatively small.However,in recent years,researchers have paid more attention to the registration of clinical trials in this field.The regional distribution of existing trial registration is not balanced,and the research design scheme needs to be improved.
作者
王维维
江昊原
陈晨
毕丹
谢勤
Wang Weiwei;Jiang Haoyuan;Chen Chen;Bi Dan;Xie Qin(Anhui University of Chinese Medicine,Hefei 230012,China;Department of Endocrinology,Tongling Hospital of Chinese Medicine,Anhui University of Chinese Medicine,Tongling 244000,China)
出处
《国际中医中药杂志》
2025年第8期1147-1152,共6页
International Journal of Traditional Chinese Medicine
关键词
桥本病
甲状腺炎
中医药疗法
临床试验注册
临床研究
Hashimoto disease
Thyroiditis
Traditional Chinese Medicine therapy
Clinical trial registration
Clinical research
