中医药治疗抑郁症临床试验注册现况分析
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国家重点研发计划项目(2017YFC1703305);国家重点基础研究发展计划“973计划”项目(2011CB505406);中国工程院院地合作项目(21ZLGCGX00030)


Analysis on the Current Situation of Clinical Trial Registration of Traditional Chinese Medicine in Treating Depression
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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平台(ClinicalTrials.gov),分析中医药治疗抑郁症相关临床试验注册的热点及现状。方法:检索建库至2022年7月31日于中国临床试验注册中心和美国临床试验注册平台注册的中医药治疗抑郁症的临床试验,提取相关资料并汇总分析。结果:纳入临床试验298项,共来自17个国家,涉及我国22个省级行政区的118家注册机构,其中注册数量前3的地域分别为北京市、广东省和上海市;纳入试验以单中心试验为主,研究类型以干预性研究为主,其中主要为随机对照试验;使用频率最高的随机方法为简单随机化方法,共118项随机对照试验明确说明应用了盲法;研究对象以卒中后抑郁症最多,干预措施以针灸最多,结局性指标以评分量表为主,使用次数最多的量表为汉密尔顿抑郁量表(HAMD)。结论:近年来相关学者对中医药治疗抑郁症临床试验注册重视程度有所提高,同时也存在试验注册地区分布不平衡、研究者在试验设计方面水平不足,对中医药临床试验特色挖掘不够等问题。

    Abstract:

    Based on Chinese Clinical Trial Registry(ChiCTR) and American clinical trial registry platform(ClinicalTrials.gov),the hotspots and current situation of clinical trial registration related to traditional Chinese medicine(TCM) treatment of depression were analyzed.Methods:The clinical trials of TCM for the treatment of depression registered by the ChiCTR and ClinicalTrials.gov from the date of library establishment until July 31,2022 were searched,and relevant data were extracted and summarized and analyzed.Results:A total of 298 clinical trials were included from a total of 17 countries,involving 118 registration institutions in 22 provincial-level administrative regions in China,of which the top 3 regions in the number of registrations were Beijing,Guangdong and Shanghai,respectively.The included trials were mainly single-center trials.The types of studies were predominantly interventional studies,of which were mainly randomized controlled trials(RCTs).The most frequently used randomized method was a simple randomization method,with a total of 118 RCTs clearly indicating the application of blinding.Poststroke depression was the most common study subject,and acupuncture was the most frequently used intervention measure.Outcome indicators were mainly based on scoring scale,and the most frequently used scale was the Hamilton Depression Scale(HAMD).Conclusion:In recent years,scholars have paid more attention to the registration of clinical trials of TCM for the treatment of depression,but there are also problems such as uneven distribution of trial registration areas,insufficient level of researchers in trial design,and insufficient exploration of clinical trial characteristics of TCM.

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张乃金,马炳旭,崔淮星,田家祺,曾仙月,孙璇,王泓午.中医药治疗抑郁症临床试验注册现况分析[J].世界中医药,2024,(06).

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  • 收稿日期:2022-11-09
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  • 在线发布日期: 2024-05-31
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