我国中医药防治冠心病临床试验注册现况分析

Analysis of Current Status of Registration of Related Clinical Trials of TCM for Protection and Treatment of Coronary Heart Disease

目的通过分析中国临床试验注册中心(ChiCTR)注册的中医药防治冠心病临床试验,了解其分布特点及发展趋势。方法计算机检索ChiCTR数据库从建库至2021年7月25日收录的中医药防治冠心病临床试验。采用Excel2019录入、去重、存档数据。采用SPSS26.0统计软件对纳入数据进行描述性分析,归纳注册临床试验的特征。结果共纳入临床试验217项,其中预注册192项。涉及16个省级行政区,65家临床机构。注册临床试验数地区分布前4位分别为北京(82项、37.79%)、广东(32项、14.75%)、上海(30项、13.82%)、天津(27项、12.44%),合计占78.80%。经费来源前3位分别为国家财政(82项、37.79%)、地方财政(40项、18.43%)、药厂/企业(31项、14.29%)。研究类型多为干预性研究(168项、77.42%),其中仅64项(38.10%)采用盲法。研究设计多为随机平行对照试验(162项、74.65%)。结论ChiCTR注册的中医药防治冠心病临床试验呈递增趋势,但存在地域不均衡性,国家及地方财政的资助对相关研究具有重要作用,试验设计和注册质量尚待进一步提高。

Objective To explore the characteristics and development trend of coronary heart disease-related clinical trials of TCM by analyzing the characteristics of coronary heart disease-related clinical trials of TCM registered in China Clinical Trial Registry(ChiCTR).Methods The clinical trials of TCM for protection and treatment of coronary heart disease in ChiCTR database were retrieved by computer.The search time limit was from the establishment of the database to July 25,2021.Excel 2019 software was used to enter,de-duplicate,and archive data.SPSS 26.0 statistical software was used to descriptively analyze the included data and summarize the characteristics of registered clinical trials.Results A total of 217 clinical trials were included,of which 192 were pre-registered,involving 16 provinces(municipalities,autonomous regions),and 65 clinical institutions.The top 4 registered clinical trials were Beijing(82 items,37.79%),Guangdong(32 items,14.75%),Shanghai(30 items,13.82%)and Tianjin(27 items,12.44%),accounting for 78.80%of the total number of registered clinical trials.The top three sources of funding were 82 items of national finance(37.79%),followed by 40 items of local finance(18.43%),and 31 items of pharmaceutical factories/enterprises(14.29%).There were 168 intervention studies(77.42%),of which only 64(38.10%)were blinded,and 162 were randomized parallel controlled trials(74.65%).Conclusion The number of TCM-related clinical trials for protection and treatment of coronary heart disease registered in ChiCTR is increasing,but there is a geographical imbalance.National and local financial funding plays an important role in the clinical trials of TCM related to coronary heart disease.The quality of trial design and registration needs to be further improved.