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中医药防治糖尿病肾病的临床试验注册现状分析
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Abstract:
目的：检索中国临床试验注册中心(ChiCTR)数据库和国际临床试验注册平台(ICTRP)，统计分析中医药治疗糖尿病肾病的临床试验注册现状，为把握相关发展形势提供借鉴。方法：按照纳排标准检索建库至2023年12月31日收录的中医药治疗糖尿病肾病的注册临床试验，经独立的2名研究者进行试验数据筛选和提取，采用Microsoft Excel 2019录入数据，并进行整理统计。结果：最终纳入79项中医药治疗糖尿病肾病注册临床试验，包括67项实验性研究(84.81%)和12项观察性研究(15.19%)。注册地区涉及17个省级行政区，注册数量最多的是北京(28项，35.44%)和上海(15项，18.99%)，经费来源以地方财政为主(49项，62.03%)。干预措施多为西医基础治疗联合中医药(34项，40.04%)，结局指标以疗效性指标为主，安全性指标和附加指标较少。结论：目前中医药治疗糖尿病肾病临床试验注册数量呈上升趋势，但整体数量仍偏少。研究者应重视注册细节和研究方案方面的优化，进一步提升注册质量。
Objective: Retrieve the Chinese Clinical Trial Registry (ChiCTR) database and the International Clinical Trial Registration Platform (ICTRP), and statistically analyze the current status of clinical trial registration of traditional Chinese medicine in the treatment of diabetic nephropathy, so as to provide reference for grasping the relevant development situation. Methods: According to the inclusion and exclusion criteria, the registered clinical trials of traditional Chinese medicine in the treatment of diabetic nephropathy from the establishment of the database to December 31, 2023 were retrieved. The experimental data were screened and extracted by two independent researchers. Microsoft Excel 2019 was used to input data and organize statistics. Results: Finally, 79 registered clinical trials of traditional Chinese medicine in the treatment of diabetic nephropathy were included, including 67 experimental studies (84.81%) and 12 observational studies (15.19%). The registered areas involved 17 provincial-level administrative regions, with the largest number of registrations in Beijing (28 items, 35.44%) and Shanghai (15 items, 18.99%). The source of funds was mainly local finance (49 items, 62.03%). The intervention measures were mostly basic treatment of Western medicine combined with traditional Chinese medicine (34 items, 40.04%). The outcome indicators were mainly efficacy indicators, and there were fewer safety indicators and additional indicators. Conclusion: At present, the number of clinical trials registration in the treatment of diabetic kidney disease with traditional Chinese medicine is on the rise, but the overall number is still small. Researchers should pay attention to the optimization of registration details and research programs to further improve the quality of registration.
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