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基于ChiCTR的国内常见肛肠疾病临床试验注册现状分析

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目的 分析中国临床试验注册中心(ChiCTR)常见肛肠疾病临床试验注册现状及中医药研究情况.方法 检索ChiCTR数据库,搜集整理与痔、肛裂、肛瘘、肛周脓肿和肛周湿疹相关的临床试验,检索时间范围自建库至2023年12月10日,对纳入注册试验的特征进行分析.结果 共纳入148项注册项目,其中75项为中医药相关临床试验,134项临床试验为预注册,121项通过伦理审查.上海、江苏、广东、北京、四川注册数量共占总数的76.35%,注册项目最多的是上海中医药大学附属曙光医院.经费资助来源前3位分别为地方财政、自筹经费和医院资助.注册项目以干预性研究为主,114项研究使用随机方法,34项研究使用盲法.结论 目前,ChiCTR注册肛肠疾病临床试验数量呈递增趋势,中医药治疗肛肠疾病特色明显,但存在注册内容填写不规范、地区分布不均衡等情况.
Analysis on Registration Status of Clinical Trials of Common Anorectal Diseases in China Based on ChiCTR
Objective To analyze the current status of clinical trial registration of common anorectal diseases in Chinese Clinical Trial Registry(ChiCTR)and the research of TCM.Methods The ChiCTR database was retrieved to collect and organize clinical trials related to hemorrhoids,anal fissures,anal fistulas,perianal abscesses,and perianal eczema.The retrieval time was from the establishment of the database to December 10,2023.Characterization of included registration trials was analyzed.Results A total of 148 registered projects were included,75 of which were TCM-related clinical trials.Among them,134 clinical trials were pre-registered and 121 passed the ethical review.Shanghai,Jiangsu,Guangdong,Beijing and Sichuan accounted for 76.35%of the total number of registrations,and the largest number of registered projects was in Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine.The top 3 funding sources were local finance,self-funding and hospital funding.The registered projects were mainly intervention studies.114 studies used randomized methods and 34 studies were blinded.Conclusion At present,the number of ChiCTR-registered clinical trials on anorectal diseases is on an increasing trend,and the treatment of anorectal diseases with TCM has obvious characteristics.However,there are cases of irregular filling of registration content and uneven regional distribution.

anorectal diseasesclinical trialChinese Clinical Trial RegistryTCM

梁彪、杨忆衡、倪嘉淳、钱诗维、黄硕、王振宜

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上海中医药大学附属岳阳中西医结合医院,上海 200437

肛肠疾病 临床试验 中国临床试验注册中心 中医药

2025

中国中医药信息杂志
中国中医科学院中医药信息研究所

中国中医药信息杂志

影响因子:0.889
ISSN:1005-5304
年,卷(期):2025.32(1)