国内中医药防治高血压临床试验注册现况分析

Analysis on Current Status of Clinical Trial Registration on Prevention and Treatment of Hypertension by TCM in China

目的通过分析中国临床试验注册中心(ChiCTR)注册的中医药防治高血压相关临床试验,探讨其分布特点及发展情况并提出相应建议。方法计算机检索ChiCTR数据库建库至2022年3月30日收录的中医药防治高血压相关临床试验,采用Excel去重并提取相关数据,采用SPSS25.0软件对提取数据的注册地区、试验机构、经费来源、研究类型、研究设计进行分析,归纳临床试验特征。结果共纳入中医药防治高血压相关临床试验86项,其中预注册78项,补注册8项;注册地区分布在13个省级行政区,涉及46家临床试验机构,临床试验注册数量地域分布前3位为北京市24项(27.91%)、广东省13项(15.12%)、山东省11项(12.79%),试验机构以山东中医药大学附属医院(9项,10.47%)注册数量最多;84项注册试验明确提及获得经费资助,经费来源排名前3位依次为国家财政22项(26.19%)、地方财政18项(21.43%)、药厂资助15项(17.86%);研究类型以干预性研究为主,共74项(86.05%),仅25项(29.07%)临床研究应用盲法;研究设计多为随机平行对照,共69项。结论我国中医药防治高血压临床试验注册数量整体呈上升趋势,研究者临床试验注册意识有所提升,但与当前现代医学防治高血压临床试验注册情况仍存在较大差距。已注册的中医药防治高血压临床试验存在试验注册地域不均衡、注册信息的完整性与规范性欠佳等问题。建议相关部门加大临床试验的注册宣教,完善临床试验注册制度,促进高质量临床试验开展,进一步发挥中医药防治高血压的优势。

Objective To explore the distribution characteristics and development trend of hypertension related clinical trials registered by Chinese Clinical Trial Registration Center(ChiCTR);To discuss its distribution characteristics and development trend,and propose relating suggestions.Methods The clinical trials related to the prevention and treatment of hypertension with TCM included in ChiCTR database were searched by computer from the database construction to March 30,2022.Excel was used to remove and extract relevant data,and SPSS25.0 was used for analysis on registered areas,trial institutions,funding sources,study types and design schemes of extracted data,and the characteristics of clinical trials were summarized.Results A total of 86 TCM hypertension related clinical trials were included,including 78 pre-registered trials and 8 re-registered trials.The registered areas were distributed in 13 provincial administrative regions,involving 46 clinical trial institutions.The top three clinical trial registration areas were 24 in Beijing(27.91%),13 in Guangdong Province(15.12%)and 11 in Shandong Province(12.79%).The affiliated Hospital of Shandong University of Traditional Chinese Medicine registered the most clinical trials(9 items,10.47%);the top 3 funding sources were 22 items from national finance(26.19%),18 items from local finance(21.43%)and 15 items from pharmaceutical factories(17.86%).There were 74(86.05%)intervention studies,and only 25(29.07%)clinical studies were blind.The study design was mostly randomized parallel controlled(69 items).Conclusion The number of registrations of clinical trials of TCM for the prevention and treatment of hypertension in China is on the rise as a whole,and researcher awareness of clinical trial registration has improved.However,compared with the current level of modern medical research,there is still a big gap between the registration of clinical trials of TCM intervention in hypertension.There are still problems in the registered clinical trials,such as regional imbalance of trial registration,and poor integrity and standardization of registration information.It is suggested that relevant departments increase the publicity and education of clinical trial registration,improve the clinical trial registration system,promote the development of high-quality clinical trials,and further give full play to the advantages of TCM in the prevention and treatment of hypertension.