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“真实世界研究”——中医药科研新思路
引用本文:付玲,周学平,李国春.“真实世界研究”——中医药科研新思路[J].浙江中医药大学学报,2013(9):1127-1129.
作者姓名:付玲  周学平  李国春
作者单位:南京中医药大学 南京 210046
摘    要:目的]研究“真实世界研究”(real—worldstudy,Rws)方法,使RWS走进医学研究人员视野,为中医药科研探索新方向。方法]回顾近年来国外开展的RWS,通过与“随机对照试验”(Randomizedcontrolledtrial,RCT)对比,总结RWS的特征,讨论运用RCT、RWS开展中医药科研的局限性和优势。结果]RWS与RCT在临床研究目的、纳入和排除标准、样本量、干预情况、评价时间及评价指标、数据采集、管理及统计分析方法等方面存在差异。结论]与RCT比较,RWS更契合中医“整体观念”及“辨证论治”的基本特征,有利于保存中医特色,为中医药科研指明新方向。

关 键 词:真实世界研究  随机对照试验  循证医学  中医药科研

“Real-world Study”(RWS)-New Approach to Traditional Chinese Medicine Scientific Research
Fu Ling , Zhou Xueping , Li Guochun.“Real-world Study”(RWS)-New Approach to Traditional Chinese Medicine Scientific Research[J].Journal of Zhejiang University of Traditional Chinese Medicine,2013(9):1127-1129.
Authors:Fu Ling  Zhou Xueping  Li Guochun
Affiliation:Nanjing University of Chinese Medicine, Jiangsu Province(210046)
Abstract:Objective]To explore new directions for traditional Chinese medicine(TCM) scientific research. Method]Reviewing RWS overseas in recent years, with a randomized controUed trial(RCT) contrast, this study summarized the RWS features and discussed the limitations and advantages of RCT and RWS when carrying out the TCM scientific research. Result] RWS is different from RCT in research purpose, brings into exclusion criteria, sample size, intervention and evaluation index, evaluation time, data collection, management and statistical analysis method, etc. Conclusion] Compared with RCT, RWS more fits the basic characteristics of TCM called holistic concept and syndrome differentiation, is advantageous to the preservation of TCM, indicat- ing the new direction for TCM scientific research.
Keywords:real-world study  randomized control ed trial  evidence-based medicine  scientific research of TCM
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