| 引用本文:何丽云1，赵天易1，刘佳1，王超1，刘保延2.中医药真实世界的病例注册登记研究进展[J].世界中医药,2022,(05):. |
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| 中医药真实世界的病例注册登记研究进展 |
| Real-world Patient Registry Study in Chinese Medicine:A Review |
| 投稿时间：2022-01-10 |
| DOI：10.3969/j.issn.1673-7202.2022.05.001 |
| 中文关键词: 中医药 中医临床评价 真实世界研究 观察性研究 病例注册登记 数据管理 病例登记平台 |
| English Keywords:Chinese medicine Clinical evaluation of Chinese medicine real-world research Observational study Patient registry Data management Patient registration platform |
| 基金项目:国家重点研发计划项目“中医药现代化研究”重点专项（2017YFC1703600）；中国中医科学院中医药科技重大成果引导项目（ZZ13-ZD-09） |
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| 中文摘要: |
| 真实世界研究作为随机对照试验的重要补充，是符合中医临床研究科研范式的方法之一。病例注册登记研究是真实世界研究中最常用的一种观察性研究方法，以中医药临床诊疗特色为基础，采集大量真实世界诊疗数据，并纳入有临床意义的结局评价指标，从而挖掘和评价出真实世界的中医药疗效及安全性。产生补充验证性试验的真实世界证据，是中医药病例注册登记研究的根本目的。本文梳理了国内外病例注册登记研究进展，并以本团队10余年的相关工作经验为基础，总结了病例注册登记研究的立项和实施过程，关键问题和关键技术，以期指导中医药真实世界病例注册登记研究的设计、实施与评估。 |
| English Summary: |
| Real-world research，as an essential supplement to randomized controlled trials，is one of the methods that conform to the clinical research paradigm in Chinese medicine.Patient registry study，one of the most commonly used observational research methods in real-world research，includes outcome evaluation indexes of clinical significance based on a large amount of real-world treatment data，thereby exploring and evaluating the real-world efficacy and safety of Chinese medicine.Generating and supplementing real-world data of confirmatory trials is the fundamental purpose of patient registry research in Chinese medicine.This paper compared the progress in case registry studies in China and abroad，and summarized the processes of launching and implementing patient registry studies，key issues，and key techniques based on our team's over ten years of experience to guide the design，implementation，and evaluation of real-world case registry studies in Chinese medicine. |
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