“真实世界研究”——中医药科研新思路

“Real-world Study”(RWS)-New Approach to Traditional Chinese Medicine Scientific Research

[目的]研究"真实世界研究"(real-world study,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"(Randomized controlled trial,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。

[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.