基于偏最小二乘-二阶因子模型的中药新药综合疗效评价实例研究  

A case study of comprehensive efficacy evaluation of traditional Chinese medicines based on partial least squares second-order latent variable model

作　　者：赵阳[1,2,3] 孙明月 高洪阳[1] 张菀桐 普心怡 杨晓晨 易丹辉 高蕊[1,2,3] ZHAO Yang;SUN Ming-yue;GAO Hong-yang;ZHANG Wan-tong;PU Xin-yi;YANG Xiao-chen;YI Dan-hui;GAO Rui(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine,National Medical Products Administration,Beijing 100091,China;National Clinical Research Center for Chinese Medicine Cardiology,Beijing 100091,China;Renmin University of China,Beijing 100872,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]国家药品监督管理局中药临床研究与评价重点实验室,北京100091 [3]国家中医心血管病临床医学研究中心,北京100091 [4]中国人民大学,北京100872

出　　处：《中国新药杂志》2022年第18期1774-1778,共5页Chinese Journal of New Drugs

基　　金：国家重点研发计划糖尿病足中西医结合防治方案的循证评价及疗效机制研究(2019YFC1709304);中央级公益性科研院所基本科研业务费专项(ZZ13-YQ-015);中国中医科学院西苑医院苗圃课题(2019XYMP-32)。

摘　　要：中药的治疗是对人的整体生命状态、疾病进程、证候及症状进行整体调节,仅使用一个结局指标难以衡量中医药的综合疗效,如何对中药治疗的整体调节的疗效进行评价,体现中医整体思维,一直以来是困扰中药临床研究的问题。偏最小二乘-二阶因子模型(PLS-SLVM)方法作为一种综合变量构建方法,基于真实数据客观赋权兼顾变量结构特征,能够建立一个有层次性和结构性的综合评价模型及其综合评分。本文通过实例分析,采用PLS-SLVM方法计算患者获益的综合评分,突破了常规疗效评价中根据单一指标评价中药疗效的局限,提供了一种具有中医临床特色的疗效综合评价方法。Traditional Chinese medicine(TCM) treatment is a overall regulation of a person’s life state, the process of disease, symptoms and signs, and it is difficult to measure the comprehensive efficacy of TCM using only one outcome indicator. How to evaluate the overall efficacy of TCM treatment and reflecting the holistic thinking of TCM, it has been a problem that has plagued clinical research on TCM. The partial least squares second-order latent variable model(PLS-SLVM), as a comprehensive variable construction method, can establish a hierarchical and structural comprehensive evaluation model and its comprehensive score based on real data with objective weighting taking the structural characteristics of variables into account. In this paper, the PLS-SLVM is used to calculate the comprehensive score of patient benefit, which breaks through the limitation of evaluating the efficacy of traditional Chinese medicine based on a single outcome in conventional efficacy evaluation and provides a comprehensive efficacy evaluation method with Chinese medicine clinical features.

关 键 词：综合评价 疗效评价 中药 临床研究 

分 类 号：R969.4[医药卫生—药理学]