Clinical Characteristics and Potential Risk Factors Analysis of Liver Injury Related to Epimedii Folium Preparation
10.13422/j.cnki.syfjx.20230712
- VernacularTitle:淫羊藿制剂相关肝损伤临床特征及潜在风险因素分析
- Author:
Yongkang ZHAO
1
;
Yuyang LIU
2
;
Wei SHI
3
;
Han GAO
4
;
Zheng LI
5
;
Zhaofang BAI
3
;
Haibo SONG
6
;
Yuan GAO
2
;
Jiabo WANG
1
;
Xiaohe XIAO
3
Author Information
1. School of Pharmacy， Chengdu University of Traditional Chinese Medicine（TCM），Chengdu 611137， China
2. School of TCM，Capital Medical University，Beijing 100069， China
3. The Fifth Medical Centre of Chinese PLA General Hospital， Beijing 100039，China
4. College of Pharmacy， Fujian University of TCM，Fuzhou 350122， China
5. School of Pharmacy， Henan University of Chinese Medicine， Zhengzhou 453000， China
6. Center for Drug Reevaluation， National Medical Products Administration， Beijing 100022， China
- Publication Type:Journal Article
- Keywords:
Epimedii Folium preparation;
adverse drug reaction;
clinical characteristics;
unreasonable drug use;
risk factor
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(6):205-210
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThis paper aims to analyze the clinical characteristics and medication rationality of liver injury related to Epimedii Folium preparation （EP） and explore the possible risk factors of liver injury， so as to provide a reference for the safe clinical application of Epimedii Folium （EF）. MethodA retrospective analysis was conducted on liver injury cases related to EP from 2012 to 2016. ResultThe number of reported liver injury cases and the proportion of severe cases related to the use of EP show an increasing trend， indicating the objective existence of liver injury caused by EP. There are more cases of liver injury related to EP in women than in men， with an onset age range of 15-91 years old and a median onset age of 60 years old （median onset ages for men and women are 59 and 60 years old， respectively）. The time span from taking EP alone to the occurrence of liver injury is 1-386 days， with a median of 38 days. The time span from taking both EP and Western medicine to the occurrence of liver injury is 1-794 days， with a median of 34 days. EF-related liver injury preparations are mostly composed of traditional Chinese medicines that promote immunity and tonify the liver and kidney， indicating that immune stress in the body may be the mechanism of liver injury caused by the use of EP alone or in combination. There is no increasing trend of toxicity with time or dose in the liver injury caused by EP. By further exploring its risk factors， it is found that patients have unreasonable medication methods such as excessive dosage， repeated use， and multi-drug combination， which may also be one of the important risk factors for EF-related liver injury. ConclusionEP has a certain risk of liver injury and should be emphasized in clinical diagnosis and treatment. Immune stress may be the mechanism of liver injury caused by EP， and in clinical use， it is necessary to be vigilant about the risk of liver injury caused by unreasonable use and combined use with Western medicine.
