Causality assessment strategies and methods for Chinese medicines-induced liver injury
10.16438/j.0513-4870.2018-0439
- VernacularTitle:中药药源性肝损伤因果关系的评价策略和方法
- Author:
Jia-bo WANG
1
;
Le ZHANG
1
;
Yu-ming GUO
1
;
Zhao-fang BAI
1
;
Xiao-he XIAO
2
Author Information
1. China Military Institute of Chinese Medicines, 302 Military Hospital of China, Beijing 100039, China
2. Integrative Medicine Center, 302 Military Hospital of China, Beijing 100039, China
- Publication Type:REVIEWS
- Keywords:
Chinese medicines;
drug-induced liver injury;
causality assessment;
integrated evidence chain
- From:
Acta Pharmaceutica Sinica
2018;53(6):920-928
- CountryChina
- Language:Chinese
-
Abstract:
Chinese medicines (CM)-induced liver injury is one of the severe adverse drug reactions (ADRs) in clinical application, which restricts new drug research and development (R&D), clinical safe usage and industry development of CM. The issue, to elucidate the causality between liver injury and CM, is either a globally challenging problem or the precondition of CM safety evaluation. However, owing to the complexicity of CM and various influencing factors to CM-induced liver injury, the causality assessment for CM is much difficult, compared to synthetic drugs. Besides, the current assessment methods, primarily designed for clinical diagnosis, are difficult to be used in new drug R&D of CM. Hereinto, we reviewed the current ADR causality methods and proposed a new strategy called integrated evidence chain-based causality assessment method for CM-induced liver injury. The new causality method is designed for new drug R&D based on the complexicity of CM, to provide methodology in scientific assessment of causality of CM-induced liver injury and to promote success rate of new drug R&D. The new method could also raise our ability to find, avoid and prevent the risk of CM-induced liver injury.
