基于HIS真实世界研究方法及其在中医临床疗效评价中的应用

Real World Study Methods and Its Application in Clinical Efficacy Evaluation of Traditional Chinese Medicine Based on HIS

真实世界研究是以患者为核心,采用宽泛的纳入标准,运用流行病学研究方法 ,在真实无偏倚或偏倚较少的人群中,研究某种或某些干预措施(包括诊断、治疗、预后)的实际应用情况。具有重视个体化诊疗,结果贴近临床实际的特点。真实世界研究方法有效果比较研究、回顾性病例对照研究、巢式病例对照研究、注册登记研究、数据挖掘方法。以医院信息系统(HIS)为技术平台的真实世界研究已经在国家中医临床研究基地为主的医疗机构应用。作为中医临床研究的一种新理念、新方法,面对复杂干预、个体化诊疗的特点,如何进行中医临床疗效评价,方法学是最大挑战。本文从真实世界研究的基本概念、特点出发,介绍和分析了真实世界研究方法,阐述了其在目前中医临床疗效评价中的应用。

The focus of real world study is the patient,with wide inclusion criteria,using epidemiology research methods in the real people with no bias or little bias to study the practical usage of some intervention measures including the diagnosis,treatment and prognosis. Attention should be paid to the individual diagnosis and treatment with the results close to the clinical practice. Real world study methods include ：the effect comparison study,retrospective case control study,nested case control study,registration study and method of data mining. Real world study based on the hospital information system（HIS） has been applied in the medical institutions of the national Chinese medicine clinical research base. As a new concept and method in traditional Chinese medicine,how to evaluate the clinical effect of traditional Chinese medicine when face to the characteristics of complex intervention and individualized diagnosis and treatment,methodology is the biggest challenge. This paper from the basic concept and characteristics of the real world study,introduces and analyses the real world study methods,expounds its application in the clinical efficacy evaluation of traditional Chinese medicine at present.