中国临床试验注册中心轻度认知障碍相关临床试验的特征分析

中华养生保健 ›› 2024, Vol. 42 ›› Issue (8): 4-5.

中国临床试验注册中心轻度认知障碍相关临床试验的特征分析

叶枫¹, 王甜¹, 符冬梅², 蔡怡欢¹, 伍娟¹, 曾奕^1,*

1.福建中医药大学康复医学院,福建福州,350122;
2.福建省第三人民医院影像科,福建福州,350122

出版日期:2024-04-16 发布日期:2024-04-08
通讯作者: ^* 曾奕,E-mail：1072636537@qq.com。
作者简介:叶枫（2003—）,男,汉族,籍贯：福建省宁德市,本科在读,研究方向：康复医学。
基金资助:
福建省自然科学基金项目（2020J01753）; 福建中医药大学校管科研课题临床专项课题（XB2023056）; 福建省教育科学“十四五”规划2022年度课题（FJJKBK22-006）

Characteristics Analysis of Clinical Trial Registration of Mild Cognitive Impairment based on Chinese Clinical Trial Registry

YE Feng¹, WANG Tian¹, FU Dong-mei², CAI Yi-huan¹, WU Juan¹, ZENG Yi^1,*

1. Rehabilitation Medicine School of Fujian University of Traditional Chinese Medicine, Fuzhou Fujian 350122, China;
2. Third People's Hospital of Fujian Province, Fuzhou Fujian 350122, China

Online:2024-04-16 Published:2024-04-08

摘要/Abstract

摘要： 目的基于中国临床试验注册中心（ChiCTR）分析MCI相关临床试验特征,了解我国MCI的研究现状和发展趋势。方法检索ChiCTR数据库自建库至2023年12月1日注册的所有MCI相关临床试验,并对其试验特征进行整理分析。结果纳入MCI临床试验241项。注册项目分布在21个直辖市/省/自治区,其中北京注册数量占比最高（17.01%）;经费来源最多为地方财政（28.63%）;研究类型中干预性研究最多（76.76%）;有16.20%的研究已逐步关注MCI合并疾病的领域。结论 ChiCTR注册的MCI临床试验数量整体呈上升趋势,但呈现地域的不均衡性,注册的试验多为干预性研究,干预手段呈多元化,MCI合并疾病的研究领域也在不断扩充,这反映了目前老龄化社会健康需求的发展趋势。但仍有部分临床试验仍显示未通过伦理审查,临床试验规范流程的知识仍需进一步普及。

关键词: 轻度认知障碍, 中国临床试验注册中心, 临床试验, 特征分析

Abstract: Objective To analyze the characteristics of mild cognitive impairment(MCI)-related clinical trials based on the Chinese Clinical Trial Registry (ChiCTR), and understand the research status and trend of MCI in China. Methods All MCI clinical trials registered in ChiCTR were retrieved from the establishment of ChiCTR to December 1, 2023. The characteristics of the clinical trials were collected and analyzed. Results A total of 241 eligible trials were included. The registered trials were distributed in 21 regional areas, of which Beijing accounted for the highest number (17.01%). The largest funding source was local finance (28.63%). The most common study type was intervention research(76.76%). And 16.2% of the studies focused on the MCI with other conditions. Conclusion There was an increasing trend in the number of MCI clinical trials registered in ChiCTR. The distribution of registration organizations showed a regional imblance. The categories of interventions were diversified while the research field of MCI combined other conditions was also expanding, reflecting the trend of health needs for the aging society. However, there were still some trials that had not passed the ethical review , which suggested that the knowledge of clinical trial procedures needed to be further popularized.

Key words: mild cognitive impairment, China clinical trial registry, clinical trials, characteristic analysis

中图分类号:

叶枫, 王甜, 符冬梅, 蔡怡欢, 伍娟, 曾奕. 中国临床试验注册中心轻度认知障碍相关临床试验的特征分析[J]. 中华养生保健, 2024, 42(8): 4-5.

YE Feng, WANG Tian, FU Dong-mei, CAI Yi-huan, WU Juan, ZENG Yi. Characteristics Analysis of Clinical Trial Registration of Mild Cognitive Impairment based on Chinese Clinical Trial Registry[J]. ZHONGHUA YANGSHENG BAOJIAN, 2024, 42(8): 4-5.

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