Objective:Appraisal of treatment outcomes in integrative medicine is a challenge due to a gap between the concepts of Western medicine(WM)disease and traditional Chinese medicine(TCM)syndrome.This study presents an approach for the appraisal of integrative medicine that is based on targeted metabo-lomics.We use non-alcoholic fatty liver disease with spleen deficiency syndrome as a test case.Methods:A patient-reported outcome(PRO)scale was developed based on literature review,Delphi con-sensus survey,and reliability and validity test,to quantitatively evaluate spleen deficiency syndrome.Then,a metabonomic foundation for the treatment of non-alcoholic fatty liver disease with spleen defi-ciency syndrome was identified via a longitudinal interventional trial and targeted metabolomics.Finally,an integrated appraisal model was established by identifying metabolites that responded in the treat-ment of WM disease and TCM syndrome as positive outcomes and using other aspects of the metabo-nomic foundation as independent variables.Results:Ten symptoms and signs were included in the spleen deficiency PRO scale.The internal reliabil-ity,content validity,discriminative validity and structural validity of the scale were all qualified.Based on treatment responses to treatments for WM disease(homeostasis model assessment of insulin resistance)or TCM syndrome(spleen deficiency PRO scale score)from a previous randomized controlled trial,two cohorts comprised of 30 participants each were established for targeted metabolomics detection.Twenty-five metabolites were found to be involved in successful treatment outcomes to both WM and TCM,following quantitative comparison and multivariate analysis.Finally,the model of the integrated appraisal system was exploratively established using binary logistic regression;it included 9 core metabolites and had the prediction probability of 83.3％.Conclusion:This study presented a new and comprehensive research route for integrative appraisal of treatment outcomes for WM disease and TCM syndrome.Critical research techniques used in this research included the development of a TCM syndrome assessment tool,a longitudinal interventional trial with verified TCM treatment,identification of homogeneous metabolites,and statistical modeling.

Liang Dai;Jing-juan Xu;Wen-jun Zhou;Ai-ping Lü;Guang Ji

Clinical Research Academy,Peking University Shenzhen Hospital,Peking University,Shenzhen 518032,Guangdong Province,China;Institute of Digestive Disease,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Department of Integrated Traditional and Western Medicine,Jinling Hospital,School of Medicine,Nanjing University,Nanjing 210002,Jiangsu Province,China;Academy of Integrative Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;School of Chinese Medicine,Hong Kong Baptist University,Hong Kong 999077,China

结合医学学报（英文版）

[1]Liang Dai;Jing-juan Xu;Wen-jun Zhou;Ai-ping Lü;Guang Ji-.Appraisal of treatment outcomes in integrative medicine using metabonomics:Taking non-alcoholic fatty liver disease with spleen deficiency syndrome as an example)[J].结合医学学报（英文版）,2022(06):524-533

lomics,metabonomic,exploratively

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