摘要 近年来，真实世界研究成为医药研究领域的热点，在中医药领域也受到广泛关注。然而，目前对于真实世界研究在中医药临床研究领域的应用价值和定位还缺乏系统的认识和思考。本文通过综合国内外学术组织、医药管理部门发布的有关真实世界研究文件及相关文献报道，结合中医药的特点和需求，梳理出中医药真实世界研究的9个应用场景：中药安全性评价、发现临床作用规律、非药物疗法效果评价、“治未病”技术评价、终点事件研究、中西药相互作用评价、中药饮片疗效评估、随机对照试验优化设计和研究假说形成，以期为中医药真实世界研究的开展提供参考，推动该领域不断走向深入。
关键词 中医药;真实世界研究;应用场景;真实世界证据;临床研究;安全性评价;研究方法;循证医学。
Application Scenarios of Real World Study in Traditional Chinese Medicine
Pang Bo1， Zheng Wenke1， Zhang Junhua1， Wang Hui1， He Liyun2， Sun Xin3， Zhang Dong1， Yang Fengwen1， Liu Chunxiang1
（1 Evidence-based Medicine Centre， Tianjin University of Traditional Chinese Medicine， Tianjin 301617， China; 2 Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China; 3 Chinese Evidence-based Medicine Centre， West China Hospital of Sichuan University， Chengdu 610041， China）
Abstract In recent years， real-world study（RWS）has become a hot topic in the field of medical research， and has been widely concerned in the field of traditional Chinese medicine（TCM）.However， there is still lack of systematic understanding and thinking about the application value and positioning of RWS in the field of clinical research of TCM.This paper detailed 9 application scenarios of RWS in TCM by summarizing the documents and related literature issued by academic organizations and medical management agency at home and abroad， combining with the characteristics and needs of TCM.The 9 application scenarios of RWS are safety evaluation of TCM， discovery of clinical regularity， evaluation of non-drug therapy′s effect， evaluation on preventive treatment techniques， end-point outcomes research， evaluation of interaction between Chinese and western medicine， efficacy evaluation of Chinese herbal slices， the optimization design of randomized controlled trials and the formation of research hypotheses.We aim to provide reference for using RWS in the field of TCM and to accelerate the development of RWS.
Key Words Traditional Chinese medicine; Real-world study; Application scenarios; Real-world evidence; Clinical trials; Safety evaluation; Study methodology; Evidence-based medicine
中圖分类号：R2-03文献标识码：Adoi：10.3969/j.issn.1673-7202.2019.12.004
临床疗效是中医药学赖以生存和发展的基础。随着循证医学（Evidence-based Medicine，EBM）的兴起，推动了中医药临床研究的快速发展，特别是随机对照试验（Randomized Controlled Trial，RCT）的数量和质量在过去20余年取得了长足进步，为彰显中医药临床价值起到关键作用[1-2]。然而RCT的应用有一定局限性，如实施难度大，运行成本高，还不能适应中医药证据需求的日益增长[3]。
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