A new research and development paradigm for pattern-based new traditional Chinese medicine compound preparations:Integrating human use experience with patient-centered principlesOA
The development of pattern-based traditional Chinese medicine(TCM)compound preparations constitutes a core domain that represents the principle of pattern differentiation-based treatment,a hallmark of TCM.However,the field has long been constrained by scientific and regulatory challenges in animal modeling,efficacy evaluation,and clinical positioning.This article proposes a new research and development(R&D)paradigm strategically based on human use experience(HUE)and centered on the patient as the key to overcoming these bottlenecks and achieving high-quality progress.We systematically dissect the traditional problems in this field and demonstrate the pivotal role of high-quality HUE in enabling precise clinical positioning and optimizing R&D pathways(e.g.,applying for exemptions from non-clinical studies).HUE guides the implementation of the“pattern-symptom integration”model.Furthermore,we detail the implementation of the patient-centered concept throughout the process of clinical trial design,collection of patients’experience data,clinical outcome assessment,and benefit-risk assessment.The integrative application of artificial intelligence in the R&D of pattern-based TCM drugs is also specifically explored.By synthesizing the“TCM theory,HUE,and clinical trials”evidence system,this article aims to provide a systematic strategic framework for establishing an R&D pathway that adheres to the intrinsic principles of TCM while simultaneously meeting modern scientific standards.
Huimin Tang;Yaqin Tang;Shihao Ni;Yanping Du;Zhongqi Yang
The First Clinical Medical School of Guangzhou University of Chinese Medicine,Guangzhou 510405,China The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Clinical Research Academy of Chinese Medicine,Guangzhou 510405,China State Key Laboratory of Traditional Chinese Medicine Syndrome,The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Engineering Research Center of Commercialization of Medical Institution Preparations and Traditional Chinese Medicines,Guangzhou 510405,China Guangdong Engineering Technology Research Center of Commercialization of Lingnan Special Medical Institution Preparations,Guangzhou 510405,ChinaThe First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Clinical Research Academy of Chinese Medicine,Guangzhou 510405,China State Key Laboratory of Traditional Chinese Medicine Syndrome,The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Engineering Research Center of Commercialization of Medical Institution Preparations and Traditional Chinese Medicines,Guangzhou 510405,China Guangdong Engineering Technology Research Center of Commercialization of Lingnan Special Medical Institution Preparations,Guangzhou 510405,ChinaThe First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Clinical Research Academy of Chinese Medicine,Guangzhou 510405,China State Key Laboratory of Traditional Chinese Medicine Syndrome,The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Engineering Research Center of Commercialization of Medical Institution Preparations and Traditional Chinese Medicines,Guangzhou 510405,China Guangdong Engineering Technology Research Center of Commercialization of Lingnan Special Medical Institution Preparations,Guangzhou 510405,ChinaThe First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Clinical Research Academy of Chinese Medicine,Guangzhou 510405,China State Key Laboratory of Traditional Chinese Medicine Syndrome,The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Engineering Research Center of Commercialization of Medical Institution Preparations and Traditional Chinese Medicines,Guangzhou 510405,China Guangdong Engineering Technology Research Center of Commercialization of Lingnan Special Medical Institution Preparations,Guangzhou 510405,ChinaThe First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Clinical Research Academy of Chinese Medicine,Guangzhou 510405,China State Key Laboratory of Traditional Chinese Medicine Syndrome,The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China Guangdong Engineering Research Center of Commercialization of Medical Institution Preparations and Traditional Chinese Medicines,Guangzhou 510405,China Guangdong Engineering Technology Research Center of Commercialization of Lingnan Special Medical Institution Preparations,Guangzhou 510405,China
医药卫生
TCM patternsHuman use experiencePatient-centered approachClinical trials
《Journal of Traditional Chinese Medical Sciences》 2026 (1)
P.12-18,7
supported by the Key Laboratory of Clinical Evaluation Technology for Human Experience with Chinese Medicine,Science and Technology Innovation Project of Guangdong Provincial Medical Products Administration(2022ZDB06)the Jointly Funded Project by Guangzhou Science and Technology Bureau,Research Institutes and Enterprises(2024A03j0355)the State Key Laboratory of Traditional Chinese Medicine Syndrome"Unveiling the List and Taking on Leadership"Project(SKLKY2025C0013)the National Key Research and Development Program of China(2025YFC3507902).
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