实用肝脏病杂志2024，Vol.27Issue(4)：531-534,4.DOI:10.3969/j.issn.1672-5069.2024.04.010
中国临床试验注册中心注册的非酒精性脂肪性肝病临床试验特征分析
Non-alcoholic fatty liver diseases:Clinical trials registered in Chinese clinical trial registry
摘要
Abstract
Objective This study summarized research status of clinical trials related to non-alcoholic fatty liver diseases(NAFLD)registered in Chinese Clinical Trials Registry(ChiCTR).Methods The ChiCTR database was searched for clinical trials related to NAFLD up to July 15,2023.Excel 2019 software was used to analyze the registration time,region and institution,funding source,research type,design scheme,intervention measures,research stage,randomization or blinding method,research centers,sample size and other feature of the included clinical trials.Results A total of 102 clinical trials related to NAFLD study were included,mainly intervention studies,with a total sample of 144694 cases;the registered areas covered 17 provinces and municipalities directly under the Central government,mainly distributed in Shanghai,Guangdong,Zhejiang and other regions;the study design was mainly randomized parallel controlled studies,while there were 37 studies missing blind method or blanks;intervention measures mainly included medicine and lifestyle,modern diagnosis and treatment technology and combined interventions;the research phase mainly included exploratory research/pre-trial,post-marketing drugs/phase 4 trial and phase I clinical trial;there were 88 single-center studies,while multi-center study seldom if ever.Conclusion The numbers of NAFLD related clinical trial registrations in China is increasing,but lack of high-level,well-designed and multi-center studies.关键词
非酒精性脂肪性肝病/临床试验/中国临床试验注册中心/特征Key words
Non-alcoholic fatty liver diseases/Clinical trials/Chinese clinical trial registry/Feature引用本文复制引用
李开楊,赵琦,黄敬,唐云,蔺晓源,刘杰民,杨梅..中国临床试验注册中心注册的非酒精性脂肪性肝病临床试验特征分析[J].实用肝脏病杂志,2024,27(4):531-534,4.基金项目
国家自然科学基金资助项目(编号:82160866) （编号:82160866）
贵州省科技计划项目[编号:黔科合基础-ZK(2023)一般433] （2023）
贵州省卫生健康委科学技术基金资助项目(编号:gzwkj2023-208) （编号:gzwkj2023-208）
贵州省高等学校重点实验室资助项目[编号:黔教技(2023)017号] （2023）
贵州省普通高等学校青年科技人才成长项目[合同书编号:黔教合KY字(2022)263号] （2022）
