| 引用本文:焦薇薇1，2，柳凯文2，申伟1，魏竞竞1，陆芳1，张允岭1，鲁喦1.中国临床试验注册中心注册中医药真实世界研究特征分析[J].世界中医药,2023,(01):. |
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| 中国临床试验注册中心注册中医药真实世界研究特征分析 |
| Real-world Research on Traditional Chinese Medicine Based on Chinese Clinical Trial Registry：A Review |
| 投稿时间：2021-11-29 |
| DOI：10.3969/j.issn.1673-7202.2023.01.021 |
| 中文关键词: 真实世界研究 中医药 中国临床试验注册中心 队列研究 集中监测 注册登记 临床试验 注册 |
| English Keywords:Real-world research Traditional Chinese medicine Chinese Clinical Trial Registry Cohort study Centralized monitoring Registration Clinical trials Registry |
| 基金项目:国家中医药管理局中医药创新团队及人才支持计划项目（ZYYCXTD-C-202007）；国家中医药管理局中医药传承与创新“百千万”人才工程（岐黄学者）（国中医药人教发[2018]12号）——国家中医药领军人才支持计划；中国中医科学院循证医学中心“业务研究室主任”专项(2020YJSZX-3) |
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| 中文摘要: |
| 目的：基于中国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特征分析。方法：在ChiCTR中检索中医药真实世界研究，检索时间为自建库至2021年10月31日。筛选并提取研究目的、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：共纳入中医药真实世界研究208项，多为前瞻性研究，研究方法以观察性研究为主，样本量3 054 440例；近10年中医药真实世界研究注册数量呈上升趋势；多中心研究的有99项，其中研究中心数最高达89项中心；研究实施周期平均29个月，最长研究周期达20年4个月；研究申办单位地域分布以北京、广东、上海为主，申办单位以医院类最多；经费来源以科研和课题经费为主；干预措施主要为口服中成药类；研究对象以心脑血管疾病、呼吸系统疾病和肿瘤3类疾病为主。结论：中医药真实世界研究注册量呈上升趋势，该领域研究注册仍存在研究者对于真实世界研究的认识理解不足、对临床试验注册的重视度不够、注册地质量不高、注册地域分布不均衡等问题。 |
| English Summary: |
| To analyze the characteristics of real-world research on traditional Chinese medicine(TCM) based on the information in the Chinese Clinical Trial Registry(ChiCTR).Methods:ChiCTR was searched for real-world studies of TCM from ChiCTR inception to October 31，2021.Data，such as research purpose，sample size，intervention measures，and evaluation indicators，were screened out and extracted，with the descriptive analysis method adopted.Results:A total of 208 real-world TCM studies were included，most of which were prospective studies.In terms of research method，the majority of studies were observational ones，with a sample size of 3 054 440 cases.In recent 10 years，real-world TCM research registration has shown an upward trend.There were 99 multicenter studies，of which the number of research centers reached 89.The average research implementation cycle was 29 months，and the longest research cycle was 20 years and 4 months.In terms of geographical distribution，the research units were mainly located in Beijing，Guangdong，and Shanghai，and the units were mostly hospitals.Funding sources were mainly scientific research and project funding.The main intervention measures were oral Chinese patent medicine.The target diseases were mainly cardiovascular and cerebrovascular diseases，respiratory diseases，and tumors.Conclusion:The real-world TCM research registration shows an upward trend.There are still some problems in the research registration in this field，such as insufficient understanding of real-world research，insufficient attention to clinical trial registration，low quality of registration，and uneven geographical distribution of registration. |
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