中医药防治糖尿病周围神经病变临床试验注册现况分析及评价

Current status of clinical trial registration of traditional Chinese medicine in the prevention and treatment of diabetic peripheral neuropathy：analysis and evaluation

关键词:  糖尿病周围神经病变  中医药  临床试验  试验注册  现状分析

Key words:  diabetic peripheral neuropathy  traditional Chinese medicine  clinical trial  trial registration  analysis of the situation

摘要:

[目的] 通过检索国内外糖尿病周围神经病变（DPN）中医药临床试验注册情况，归纳其特征及发展趋势，为今后开展中医药防治DPN临床试验设计提供参考。[方法] 应用计算机在国际临床试验注册平台（WHO ICTRP）检索DPN中医药临床试验；检索时限为建库至2022年8月31日。对检索DPN中医药临床试验进行查重并提取相关数据。提取相关临床试验信息，并归纳DPN中医药临床试验特征（注册时间、地域及机构、设计类型、样本量、干预措施、结局指标）。[结果] 纳入中医药防治DPN临床试验26项；临床试验注册地均为中国，均在国内开展相关临床试验；注册单位分布在全国10个省级行政区，20家临床注册机构。分布最多的3个地区分别为上海市（8项）、北京市（5项）、广东省（5项）；经费来源以省级基金资助最多为8项，其次为院级科研基金资助6项；研究类型以干预性研究为主，随机平行对照试验是在册DPN的主要研究设计类型，12项研究为预试验，构成比为46.15%；纳入临床试验总样本量为3 854例，13项临床试验受试者例数≤100例；5项试验以针灸为干预措施；试验注册设计了145个结局指标，23项试验设计了神经传导速度。[结论] 中医药防治DPN临床试验注册数量整体偏少，数量呈上升趋势，中医药防治DPN优势明显，但在临床试验设计和注册规范性方面有待加强。

Abstract:

[Objective] To summarize the characteristics and development trend of traditional Chinese medicine（TCM） clinical trials on diabetic peripheral neuropathy（DPN） by searching the registration of TCM clinical trials at home and abroad，and to provide reference for the design of clinical trials on the prevention and treatment of DPN with TCM in the future. [Methods] The clinical trials of DPN were searched by computer in the international clinical trial registry（WHO ICTRP）. The search period is from August 31，2022. The DPN clinical trials were reviewed and the relevant data were extracted. Relevant clinical trial information was extracted，and the characteristics of DPN traditional Chinese medicine clinical trials（registration time，region and institution，design type，sample size，intervention measures，outcome indicators） were summarized. [Results] The 26 clinical trials on the prevention and treatment of DPN with traditional Chinese medicine were included. All clinical trials were registered in China and conducted in China. Registered units are distributed in 10 provincial-level administrative regions and 20 clinical registration institutions. The top three regions were Shanghai（8 items），Beijing（5 items） and Guang Zhou province（5 items）. The funding sources were provincial funds at most 8 projects，followed by 6 projects funded by academic research funds. The main research type was intervention study. Randomized parallel controlled trial was the main research design type of registered DPN. The 12 studies were preliminary trials，with a constituent ratio of 46.15%. The total sample size of the included clinical trials was 3 854，and the number of subjects in 13 clinical trials was less than 100. Five trials used acupuncture as an intervention；a total of 145 outcome indicators were registered and nerve conduction velocity was designed for 23 trials. [Conclusion] The registered number of clinical trials for the prevention and treatment of DPN by traditional Chinese medicine is relatively small on the whole，and the number is on the rise. Traditional Chinese medicine has obvious advantages in the prevention and treatment of DPN，but the design and registration of clinical trials need to be strengthened.