真实世界中医临床研究方法与实践

Method and Practice of Real- world Clinical Research of Traditional Chinese Medicine

本文论述了临床研究方法从理想世界到真实世界的转变,介绍了中医临床研究的特殊性,并对中医真实世界研究(RWS)的实践进行回顾,通过分析RWS在中医临床疗效评价中的优势,进而得出RWS与随机对照试验(RCT)相比更适合中医药临床研究的实际。RWS为中医复杂干预、体现中医治疗慢性病优势的结局评价提供了解决方案。将RWS应用到中医药临床科研为经验医学与偱证医学的结合提供了契机,推动中医药走向世界。

The paper discussed the transition of clinical research method from ideal world to real world,introduced the particularities of the clinical research of TCM,and reviewed the practice of real- world study（ RWS） of TCM. By analyzing the advantages of RWS in the evaluation of clinical efficacy of TCM treatment,we concluded that RWS is superior to RCT in the clinical research of TCM. RWS provides solutions for complex TCM intervention and the evaluation of the advantages of TCM treatment of chronic diseases. The application of RWS in the clinical research of TCM provides an opportunity for the combination of empirical medicine and evidence- based medicine,promoting the widespread application of TCM in the world.