定量与定性研究方法相结合的中医临床疗效评价模式

循证医学对医疗决策的影响是通过利用当前所能获得的最佳临床研究证据,与医生个人的经验、患者的价值观与选择相结合而实现的。然而,现有的临床疗效评价方法——随机对照试验难以体现中医的人文属性和整体观以及辨证论治的特点。本文针对中医个体化复杂干预及其社会学属性,提出了定量与定性研究方法相结合的中医临床疗效评价模式,体现了传统中医学集社会与自然科学为一体的特征,能够全面地反映中医学整体观的诊疗过程,适合于评价辨证论治的复杂干预,希望借此提出与新药研发的中医疗效评价模式不同的新思路与方法学模式。

英文摘要:

The core of evidence-based medicine lies in implementing the current best available evidence of clinical research to direct the decision making in clinical practice,incorporation of individual experience and value and preference of patients. However,the current evaluation method for clinical therapeutic effect cannot reflect the humanity and wholesomeness as well as individualized tailored treatment of Chinese medicine (CM) by using randomized controlled trials. This assay addressed the complex intervention of highly individualized treatment of CM and its societal characteristics,and the author proposes a model for the evaluation of therapeutic effects of CM in which quantitative and qualitative methods are combined,embodying the characteristics of the social and natural sciences in CM. The model can show the dynamic process of CM diagnosis and treatment from a perspective of the whole system and can be used for the evaluation of complex intervention of CM. We hope to raise a different thinking and method from the new drug development in the therapeutic effect evaluation.

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