Research on Development Path and Strategy of Human Use Experience in Traditional Chinese Medicine Based on Bibliometrics and Thematic Analysis
10.13422/j.cnki.syfjx.20260521
- VernacularTitle:基于文献计量与主题分析的中药人用经验发展路径与策略研究
- Author:
Yundan WU
1
;
Qun CHEN
1
;
Jie CHEN
1
;
Yuhang OU
1
;
Jindong WU
1
;
Yan XIAO
2
;
Jiemei GUO
2
;
Jing CAI
1
;
Youxin SU
2
Author Information
1. The Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine， Fuzhou 350108，China
2. Fujian University of Traditional Chinese Medicine， Fuzhou 350122，China
- Publication Type:Journal Article
- Keywords:
human use experience;
traditional Chinese medicine;
new drug research and development;
development path;
practical application
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(7):118-128
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThe development trend and knowledge structure of the research on human use experience （HUE） of traditional Chinese medicine （TCM） were systematically reviewed， and the core challenges and future directions were identified. This study aims to provide reference for the construction of a scientific and feasible research and development framework and evidence transformation system. MethodsLiterature related to "human use experience" published from January 1， 2019 to July 31， 2025 was retrieved from the China National Knowledge Infrastructure （CNKI）， Wanfang， China Science and Technology Journal Database （VIP）， and PubMed databases. Bibliometric visualization was conducted using Excel， VOSviewer， and CiteSpace， followed by in-depth reading and thematic summarization of core literature. ResultsA total of 181 papers were included for bibliometric analysis， with 45 articles used for in-depth thematic mining. The analysis showed that the number of publications on HUE research has increased in a stepwise manner over the past five years. Yang Zhongqi （24 times） was the core of the author network， the journal with the highest number of publications was China Journal of Chinese Materia Medica， the institutions publishing the most articles were mainly research institutions， regulatory agencies， hospitals， and universities， high-frequency keywords included "new TCM drugs"， "real-world studies"， and "clinical comprehensive evaluation"， keyword clustering analysis formed three major clusters： Policy orientation， application fields， and methodological approaches. Thematic analysis reveals that HUE-based evaluation should be integrated throughout the research and development process， encompassing three dimensions： TCM theory， clinical value， and pharmaceutical fundamentals， with toxic herbs and compatibility contraindications being key foci. Data collection primarily relies on empirical data， while real-world data constitute the primary source for clinical research， with efficacy and safety as the shared core. Data management emphasizes quality control and statistical analysis； however， the management of bias and confounding remains a critical bottleneck in evidence transformation. In practice， HUE-based approaches have successfully supported the registration and evaluation of multiple categories of new TCM drugs. ConclusionThe research on HUE of TCM has formed a policy-driven pattern characterized by， rapid development and close link with regulatory practice. A technical framework covering the whole chain of research and development has been constructed with clinical value as the core， which provides methodological basis and strategy reference for the scientific transformation of HUE of TCM from "experience" to "evidence".
