Establishment and Implementation of Post-marketing Benefit-risk Assessment Strategy for Traditional Chinese Medicine
10.13422/j.cnki.syfjx.20251467
- VernacularTitle:中药上市后获益-风险评价策略的建立和实施
- Author:
Meng QIAO
1
;
Wenxi PENG
1
;
Qiang ZHANG
2
;
Chao LEI
3
;
Yanming XIE
1
;
Zhifei WANG
1
Author Information
1. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences，Beijing 100700，China
2. The First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou 450000，China
3. Guang'anmen Hospital，China Academy of Chinese Medical Sciences，Beijing 100053，China
- Publication Type:Journal Article
- Keywords:
benefit-risk assessment;
post-marketing evaluation of traditional Chinese medicine;
indicator system;
index weight;
criteria attributes;
multi-criteria decision analysis
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(18):253-260
- CountryChina
- Language:Chinese
-
Abstract:
The field of post-marketing benefit-risk assessment for traditional Chinese medicine（TCM） is still in its nascent stage， lacking a universally accepted and cohesive evaluation framework and standards. This study presented a strategy developed for the benefit-risk assessment of post-marketing of TCM， and explored the critical techniques and specific implementation steps involved in the assessment process. Initially， appropriate qualitative assessment frameworks and quantitative analysis models were selected for the integrated qualitative and quantitative benefit-risk assessment. Subsequently， key technologies were outlined， including the establishment of a benefit-risk indicator system， the assignment of indicator weights， and the definition of criteria attributes. Furthermore， the implementation steps were elaborated， which involved defining decision-making issues， data collection， evaluation methodologies， variability factors， and sensitivity analysis. Finally， a case study of the benefit-risk assessment of a TCM injection for hepatitis B treatment was conducted to validate the feasibility of the proposed strategy. The objective of this research was to provide theoretical support and practical references for the development of a comprehensive post-marketing benefit-risk assessment system for TCM.
