Construction of an Efficacy Evaluation System for Traditional Chinese Medicine in the Treatment of Idiopathic Pulmonary Fibrosis under the Model of Combination of Disease and Syndrome

YANG Xiaoxuan; PANG Lijian; LYU Xiaodong; WANG Linlin; WANG Xiaohan; CHEN Zhiyi; ZHANG Cheng; WANG Jiaqi

doi:10.3969/j.issn.1672-7185.2026.01.002

Abstract：Objective To address the issues of inconsistent evaluation systems and unclear standards for assessing the efficacy of traditional Chinese medicine(TCM)in treating idiopathic pulmonary fibrosis(IPF)under the current syndrome-disease combination model,this study systematically analyzes existing clinical research to construct a scientific,practical,and TCM-characterized framework for efficacy evaluation.Methods The systematic search of the China National Knowledge Infrastructure(CNKI)database identified randomized controlled trials of TCM treatment for IPF under the disease syndrome combination model in the past decade.The efficacy evaluation indicators in the trials were mined,frequency analyzed,and summarized.Based on clinical feasibility and the characteristics of TCM diagnosis and treatment,a TCM treatment efficacy evaluation system for IPF was constructed.Results This study included a total of 135 literature sources.The findings indicated that current efficacy evaluation metrics were primarily based on Western medicine"disease"outcomes,supplemented by TCM"syndrome"indicators.For TCM indicators,syndrome score results served as the primary efficacy metric,while the 6-minute walk test and quality of life scales acted as secondary metrics.Under the disease-syndrome integrated model,there remained inconsistency in efficacy evaluation criteria for TCM treatment of IPF,with unclear primary and secondary metrics,their quantitative standards,and standardized evaluation processes.Conclusion Screening specific indicators that can sensitively reflect and evaluate the efficacy of patients with IPF,and forming a efficacy evaluation system that can meet both the individualized diagnosis and treatment characteristics of TCM and the common diagnostic criteria of Western medicine,are urgent problems that need to be solved.Based on the research results,we have preliminarily constructed a multidimensional efficacy evaluation framework that includes TCM syndromes and core symptoms(core layer),key Western medicine indicators(objective layer),quality of life and functional status(effect layer),and safety layer.This framework strives to balance the individualized characteristics of TCM with the objective standards of Western medicine,in order to provide reference for future clinical research and practice.