基于临床试验注册信息分析中医药真实世界研究现状(1)
摘要 基于中國临床试验注册中心平台(ChiCTR)的注册信息，对中医药真实世界研究现状进行分析。方法：检索中国临床试验注册中心网站(www.chictr.org.cn)，以实用性临床试验、实效性临床试验、回顾性数据研究、队列研究、登记数据库、电子病历、集中监测、真实世界、注册研究、注册登记、登记研究为检索词，收集中医药相关真实世界研究信息。按照纳入排除标准筛选文献，并提取研究注册年份、研究目的、研究类型、申办单位、研究对象、样本量、干预措施、评价指标等数据，采用描述性分析方法。结果：检索获得761个研究信息，筛选后纳入中医药真实世界研究92个，总样本量2 466 311例，多为前瞻性研究;以评价有效性为目的的研究74个，评价安全性的集中监测研究18个;研究申请注册单位以北京为主;干预措施主要为中药注射剂和口服类中成药，目标疾病以心脑血管疾病为主。结论：中医药真实世界研究呈增长趋势，应用于中医和中药相关措施的临床有效性和安全性评价领域，研究类型多为前瞻性观察研究。
关键词 真实世界研究;中医药;临床试验注册;观察性研究;队列研究;集中监测;有效性;安全性
Analysis of Real World Study of Traditional Chinese Medicine Based on Chinese Clinical Trial Registry
Wang Hui， Hu Haiyin， Ji Zhaochen， Pang Wentai， Liu Chunxiang， Zheng Wenke， Yang Fengwen， Zhang Junhua
(Evidence-based Medicine Center， Tianjin University of Traditional Chinese Medicine， Tianjin 301617， China)
Abstract Objective：Based on the registration information of Chinese clinical trial registry center platform(ChiCTR)， this paper analyzed the research status of traditional Chinese medicine in the real world.Methods：The website of Chinese Clinical Trials Registry Center(www.chictr.org.cn)was searched.Practical clinical trials， actual clinical trials， retrospective data studies， cohort studies， registration databases， electronic medical records， centralized monitoring， real world， registration studies were used as search terms to collect real world research information related to traditional Chinese medicine.Literature was screened according to inclusion and exclusion criteria， and data such as research registration year， research purpose， research type， bidding unit， research object， sample size， intervention measures， evaluation index， etc.were extracted and descriptive analysis method was adopted.Results：A total of 761 research information was retrieved and 92 real world studies of traditional Chinese medicine were included after screening， with a total sample size of 2466311 cases， mostly prospective studies; 74 studies aimed at evaluating effectiveness and 18 centralized monitoring studies to evaluate safety.Beijing is the main research application registration unit.Intervention measures are mainly traditional Chinese medicine injections and oral Chinese patent medicines， and the target diseases are mainly cardiovascular and cerebrovascular diseases.Conclusion：The real-world study on traditional Chinese medicine is on the increase.It is applied to the clinical effectiveness and safety evaluation of traditional Chinese medicine and related measures.The research types are mostly prospective observation studies., http://www.100md.com(王辉 胡海殷 季昭臣 庞稳泰 刘春香 郑文科 杨丰文 张俊华)
关键词 真实世界研究;中医药;临床试验注册;观察性研究;队列研究;集中监测;有效性;安全性
Analysis of Real World Study of Traditional Chinese Medicine Based on Chinese Clinical Trial Registry
Wang Hui， Hu Haiyin， Ji Zhaochen， Pang Wentai， Liu Chunxiang， Zheng Wenke， Yang Fengwen， Zhang Junhua
(Evidence-based Medicine Center， Tianjin University of Traditional Chinese Medicine， Tianjin 301617， China)
Abstract Objective：Based on the registration information of Chinese clinical trial registry center platform(ChiCTR)， this paper analyzed the research status of traditional Chinese medicine in the real world.Methods：The website of Chinese Clinical Trials Registry Center(www.chictr.org.cn)was searched.Practical clinical trials， actual clinical trials， retrospective data studies， cohort studies， registration databases， electronic medical records， centralized monitoring， real world， registration studies were used as search terms to collect real world research information related to traditional Chinese medicine.Literature was screened according to inclusion and exclusion criteria， and data such as research registration year， research purpose， research type， bidding unit， research object， sample size， intervention measures， evaluation index， etc.were extracted and descriptive analysis method was adopted.Results：A total of 761 research information was retrieved and 92 real world studies of traditional Chinese medicine were included after screening， with a total sample size of 2466311 cases， mostly prospective studies; 74 studies aimed at evaluating effectiveness and 18 centralized monitoring studies to evaluate safety.Beijing is the main research application registration unit.Intervention measures are mainly traditional Chinese medicine injections and oral Chinese patent medicines， and the target diseases are mainly cardiovascular and cerebrovascular diseases.Conclusion：The real-world study on traditional Chinese medicine is on the increase.It is applied to the clinical effectiveness and safety evaluation of traditional Chinese medicine and related measures.The research types are mostly prospective observation studies., http://www.100md.com(王辉 胡海殷 季昭臣 庞稳泰 刘春香 郑文科 杨丰文 张俊华)