Thinking of comparative effectiveness research of the combination in the real traditional Chinese medicine world

Huaxin Shi, Qi Xie, Xiaodong Li, Baoyan Liu, Z. Wen
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引用次数: 1

Abstract

The research of traditional Chinese medicine clinical represented by the randomized controlled trial (RCT) has developed rapidly, But it also revealed two problem. The “combination between disease and syndrome” reflects the common law of disease and the patient's personality characteristics, and individual therapy focuses on dynamic effect which is more suitable for research environment in the real world the Institute of Medicine of the US National Academy of Science proposed the comparative effectiveness research (CER) to compare the research and analysis of different treatment methods. Building clinical research methods in the real world needs to carry on innovative exploration, and studies the methods and specifications of clinical research in the real world from the elements of clinical design, the control of bias, data management, statistical analysis, ethics and other clinical researches. On the basis, the comparative effectiveness research of “real world” and the “combination between disease and syndrome” needs to be carried out. The comparative effectiveness research of traditional Chinese medicine in the real world includes retrospective and prospective studies. The retrospective study is to analyze and compare based on historical data to provide clues and evidence for prospective study. The prospective study is to build follow-up platform for patients to carry on prospective study design.
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现实中医学中联合比较疗效研究的思考
以随机对照试验(RCT)为代表的中医临床研究发展迅速,但也暴露出两个问题。“病证结合”反映了疾病的共同规律和患者的人格特征,个体化治疗注重的是动态效果,更适合现实世界的研究环境。美国国家科学院医学研究所提出了比较疗效研究(CER),对不同治疗方法进行比较研究和分析。构建现实世界中的临床研究方法需要进行创新探索,从临床设计、偏倚控制、数据管理、统计分析、伦理等临床研究要素对现实世界中的临床研究方法和规范进行研究。在此基础上,需要开展“真实世界”与“病证结合”的比较有效性研究。中药在现实世界中的比较疗效研究包括回顾性研究和前瞻性研究。回顾性研究是在历史资料的基础上进行分析比较,为前瞻性研究提供线索和证据。前瞻性研究是为患者建立随访平台,进行前瞻性研究设计。
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