国内中医药防治肺癌临床试验注册现况分析

Current status of clinical trial registration on prevention and treatment of lung cancer by Chinese medicine in China

关键词:  肺癌  中医药  中国临床试验注册中心

Key words:  lung cancer  traditional Chinese medicine  Chinese Clinical Trial Registry

摘要:

[目的] 通过分析中国临床试验注册中心（ChiCTR）注册内与中医药防治肺癌相关的临床试验，探讨其注册特点及发展趋势。[方法] 计算机检索ChiCTR数据库从建库至2021年12月31日中医药防治肺癌相关的临床试验。对检索到临床试验进行查重并提取相关数据。应用SPSS 26.0软件对纳入研究数据进行统计分析，并归纳临床试验特征。[结果] 共纳入中医药防治肺癌临床试验94项，其中预注册85项；临床试验注册单位分布在中国17个省级行政区，40家临床注册机构。临床试验注册排名前3位的地区分别为：北京市、上海市、广东省；经费来源位居前3位依次为：地方财政24项（25.53%）、国家财政17项（18.06%）、自筹经费14项（14.89%）；研究类型以干预性研究为主，仅有17项研究使用盲法。[结论] 中国中医药防治肺癌临床试验注册数量总体呈现上升趋势，研究者临床注册意识显著提高，但试验设计及规范性欠佳，且试验注册存在明显地域分布不均衡，倡导研究者加强临床试验注册规范化，建议管理部门建立更完善的注册审核制度，以期未来能更进一步发挥中医药防治肺癌的优势。

Abstract:

[Objective] To explore the registration characteristics and development trend of clinical trials related to the treatment of lung cancer with traditional Chinese medicine （TCM） registered in The Chinese Clinical Trial Registry （ChiCTR）. [Methods] ChiCTR database was searched for clinical trials related to TCM treatment of lung cancer from its establishment to December 31，2021. Re-check and extract relevant data from retrieved clinical trials. Spss26.0 software was used for statistical analysis of the included data，and the characteristics of the clinical trial were summarized. [Results] A total of 94 clinical trials of TCM prevention and treatment of lung cancer were included，among which 85 were pre-registered. Clinical trial registration units are distributed in 17 provincial administrative regions and 40 clinical registration institutions. The top three regions for clinical trial registration were Beijing，Shanghai and Guangdong Province；The top three sources of funds were：24 items from local finance （25.53%），17 items from national finance （18.06%） and 14 items from self-raised funds （14.89%）. The types of studies were mainly intervention studies，and only 17 studies were blind. [Conclusion] TCM prevention and treatment of lung cancer clinical trial registration number in China present a tendency of increasing overall，the researchers registered clinical consciousness increased significantly，but the poor design of experiment and normative，and the trial registration obvious uneven geographical distribution，advocate the researchers to strengthen clinical trial registration standardization，management are suggested to create more perfect registration system of audit，In order to further develop the advantages of TCM to prevent lung cancer in the future.