Analysis of voriconazole-related hepatic dysfunction risk signals based on clinical application data
10.13699/j.cnki.1001-6821.2024.09.023
- VernacularTitle:基于临床应用数据的伏立康唑相关肝损伤风险信号分析
- Author:
Ju-Ping YUN
1
;
Zi-He WANG
;
Wei LIU
Author Information
1. 首都医科大学附属北京佑安医院药学部,北京 100069
- Keywords:
voriconazole;
hepatic dysfunction;
invasive aspergillosis;
real-world study;
Food and Drug Administration Adverse Event Reporting System
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(9):1350-1354
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine and conduct comparative analysis for hepatic dysfunction adverse events of voriconazole and other antifungal drugs,based on the Food and Drug Administration Adverse Event Reporting System(FAERS)database,and provide reference for clinical practice.Methods Data from January 2004 to March 2022 in FAERS were retrieved.We estimate the association between the hepatic dysfunction events and voriconazole using reporting odds ratio(ROR)for mining the adverse drug event report signals and compare voriconazole with the full database and other antifungal drugs.Results A total of 646 reports of hepatic dysfunction related to voriconazole as the primary suspect drug were collected totally.The median time to event of the hepatic dysfunction events was 8 d.The overall ROR 95％confidence interval(CI)for hepatic-related adverse drug events was 6.82(95％CI=6.26-7.42).Comparing to other antifungal drugs,voriconazole significantly increased the risk of hepatic dysfunction compared with fluconazole,isavuconazole and amphotericin B,with RORs of 2.19(95％CI=1.94-2.47),2.31(95％CI=1.66-3.22)and 1.26(95％CI=1.08-1.48).The top 10 adverse event signals are cholestasis,hepatic cytolysis,mixed liver injury,hepatitis cholestatic,blood alkaline phosphatase increased,γ-glutamyltransferase increased,hepatic function abnormal,hepatocellular injury,liver function test abnormal and hepatosplenomegaly,and all of them have great correlation with voriconazole(ROR＞5).Conclusion Voriconazole is closely related to hepatic dysfunction,indicating that clinical attention should be paid to patients'hepatic function indicators during medication.Since the risk of hepatic dysfunction caused by voriconazole depends on several factors including the underlying disease of the patient and the exposure level of the drugs,close clinical and laboratory monitoring,including therapeutic drug monitoring,are essential to prevent or promptly recognize further deterioration of the hepatic function.
