Clinical case analysis and disassembled prescription study of liver injury related to Xianling Gubao
10.16438/j.0513-4870.2020-1477
- VernacularTitle:仙灵骨葆相关肝损伤的临床病例分析及拆方实验研究
- Author:
Ying HUANG
1
,
2
;
Ya-lei LIU
3
;
Run-ran MA
3
;
Chun-yu LI
4
;
Zhi-jie MA
5
;
Jing JING
3
;
Yuan GAO
6
;
Peng SHEN
7
;
Hong-bo LIN
7
;
Yu-ming GUO
3
;
Zhao-fang BAI
3
;
Xiao-he XIAO
3
;
Jia-bo WANG
3
Author Information
1. School of Pharmacy, Hunan University of Chinese Medicine, Changsha 410208, China
2. China Military Institute of Chinese Medicine, the Fifth Medical Centre of Chinese PLA General Hospital, Beijing 100039, China
3. China Military Institute of Chinese Medicine, the Fifth Medical Centre of Chinese PLA General Hospital, Beijing 100039, China
4. Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100039, China
5. Beijing Friendship Hospital, Capital Medical University, Beijing 100039, China
6. School of Traditional Chinese Medicine, Capital Medical University, Beijing 100039, China
7. Ningbo Yinzhou District Center for Disease Control and Prevention, Ningbo 315000, China
- Publication Type:Research Article
- Keywords:
Xianling Gubao;
integrated evidence chain;
immune stress;
Epimedii Folium;
Psoraleae Fructus;
compatibility-mediated toxicity
- From:
Acta Pharmaceutica Sinica
2021;56(1):266-273
- CountryChina
- Language:Chinese
-
Abstract:
Xianling Gubao is a common and effective medicine in the treatment of orthopedic diseases. In recent years, it has been reported to be associated with liver injury. However, through the analysis of the adverse drug reaction reports and key hospital cases, we found that there is considerable incomplete information in the reports of Xianling Gubao-related liver injury cases retrieved from the literature. Thus, it is difficult to accurately judge causality between the drug and liver injury. Six cases of liver injury related to Xianling Gubao were identified in key hospitals, two of which achieved the clinical diagnosis according to the assessment of the integrated evidence chain method. We further analyzed the public health data of all residents in Yinzhou. The gross incidence rate of Xianling Gubao-related liver injury was 0.034%, which corresponds to a level of rare incidence. This revealed that Xianling Gubao-related liver injury has significant divergence in individuals and an idiosyncratic nature. The gross incidence of liver injury related to Xianling Gubao was lower than that of other medicines for the treatment of orthopedic diseases. Based on the idiosyncratic drug-induced liver injury model mediated by immune stress, it was found that Epimedii Folium and Psoraleae Fructus were the major components that lead to liver injury, and the liver injury caused by a full prescription was less serious than that encountered with only Epimedii Folium and Psoraleae Fructus. This suggests that the other 4 herbs (Dipsaci Radix, Anemarrhenae Rhizoma, Rehmanniae Radix,Salviae Miltiorrhizae Radix et Rhizoma) can prevent/alleviate the liver injury. Through disassembled prescription analysis, we found that the attenuation efficacy of Salviae Miltiorrhizae Radix et Rhizoma was the most significant. In conclusion, Xianling Gubao may cause idiosyncratic liver injury in a tiny minority of susceptible individuals, but the incidence risk is lower than that of other commonly used drugs for orthopedic disease. Xianling Gubao should be discreetly applied to patients with immune stress. The major components that induced liver injury in Xianling Gubao were Epimedii Folium and Psoraleae Fructus, and Salviae Miltiorrhizae Radix et Rhizoma appears to attenuate this toxicity. This study provides a reference for the rational clinical medication with Xianling Gubao.