摘要
随机对照试验是经典的药物安全性及疗效评价方法,但自身也存在一定的局限性。真实世界研究在世界范围内越来越受到研究者的重视,真实世界研究源于真实临床医疗环境的证据,研究结果临床适用性高。中医药强调以人为本,个性化治疗,这与真实世界研究更注重临床实际应用的特点不谋而合。真实世界研究应用于中医药临床评价尚处于起步阶段,当前其主要应用于中成药上市后再评价、中医临床治疗的证候特点分析、中医诊疗指南适用性评价及名老中医经验传承方面。本文就真实世界研究在中医药领域最新应用情况及数据质控策略做一综述。
Randomized controlled trial is classical method for evaluation of drug’s safety and effect,but it has some limitation.Real-world study is being paid more and more attention around the world.The real-world study is based on evidence from the real clinical medical environment.The results of the study are high in clinical applicability.The characteristic of traditional Chinese medicine is individualized treatment,which is more consistent with the real-world study on the characteristics of clinical practice.Application of real-world study on traditional Chinese medicine clinical evaluation is still in initial stage.Most applications are post-marketing evaluation,analysis of traditional Chinese medicine syndrome,analysis on the current status of applicability evaluation of clinical practice guideline,inheritance and development of the experience of veteran doctors of traditional Chinese medicine.This article summarizes the condition of application of real-world study on traditional Chinese medicine and to discuss the data quality control of real-world study.
作者
邢永发
王保和
黄宇虹
XING Yongfa;WANG Baohe;HUANG Yuhong(Second affiliated hospital of tianjin university of TCM,Tianjin 300250,China)
出处
《环球中医药》
CAS
2018年第4期625-630,共6页
Global Traditional Chinese Medicine
基金
科技部"十二.五"国家新药创制重大专项课题(2015ZX09101043-009)
关键词
真实世界研究
中医药
临床评价
Real-world study
Traditional Chinese medicine
Clinical evaluation
