中医药治疗腰椎间盘突出症的临床试验注册现状分析
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国家重点研发计划项目(2021YFC1712800,2021YFC1712802);国家中医药传承创新团队项目(ZYYCXTD-C-202003)


Status of Clinical Trial Registration of Traditional Chinese Medicine Treatment of Lumbar Disc Herniation
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    目的:基于中国临床试验注册中心(ChiCTR)和美国临床试验注册中心(ClinicalTrials.gov)数据库,分析总结中医药治疗腰椎间盘突出症临床试验注册现状,为今后相关临床试验注册和实施提供借鉴。方法:系统检索ChiCTR和ClinicalTrials.gov建库至2023年5月31日收录的中医药治疗腰椎间盘突出症注册临床试验,2名研究者独立进行试验筛选和数据提取,采用Microsoft Excel 2019录入数据,并进行整理统计。结果:最终纳入87项中医药治疗腰椎间盘突出症注册临床试验,包括78项干预性研究和9项观察性研究。国内注册地区涉及17个省级行政区,注册数量最多的是上海市和北京市,经费来源以地方财政为主。干预措施多为中医药疗法的联合,结局指标以疗效性指标为主,安全性指标较少。结论:目前中医药治疗腰椎间盘突出症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。

    Abstract:

    Based on the Chinese Clinical Trial Registry(ChiCTR) and ClinicalTrials.gov,this study analyzed the status of clinical trial registration of traditional Chinese medicine(TCM) treatment of lumbar disc herniation,aiming to provide reference for the future clinical trial registration and implementation.Methods:The registered clinical trials of TCM treatment of lumbar disc herniation were searched against ChiCTR and ClinicalTrials.gov with the time interval from inception to May 31,2023.Two researchers independently screened the trials and extracted the data.The data were then organized and analyzed in Microsoft Excel 2019.Results:A total of 87 registered clinical trials of TCM treatment of lumbar disc herniation were included,including 78 intervention studies and 9 observational studies.The registered trials in China involved 17 provincial-level administrative regions,in which Shanghai and Beijing had the largest number of registered trials.The funds supporting these trials were mainly from local finance.The combinations of multiple Chinese medical therapies were the most common intervention measures.The outcome indicators mainly involved efficacy and rarely safety.Conclusion:The number of clinical trials registered for the TCM treatment of lumbar disc herniation is on the rise,while the number is relatively small.Researchers should pay attention to the optimization of registration details and research schemes to improve the quality of registration.

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秦晓宽,孙凯,孙传睿,肖想玉,魏戌,朱立国.中医药治疗腰椎间盘突出症的临床试验注册现状分析[J].世界中医药,2023,(21).

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  • 收稿日期:2023-08-01
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  • 在线发布日期: 2023-12-29
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