A real-world study of azivudine tablets for drug-induced liver injury caused by novel coronavirus pneumonia
OBJECTIVE To explore the occurrences and risk factors of drug-induced liver injury(DILI)caused by azivudine tablets for corona virus disease 2019(COVID-19)in real world and provide references for safe clinical dosing.METHODS From November 30,2022 to January 26,2023,medical records were retrospectively reviewed for 294 hospitalized patients taking azivudine tablets for COVID-19.Age,gender,weight,dosage,course of treatment,co-medication,liver function parameters and adverse reactions of causing liver injuries were recorded.Basic characteristics of azvudine DILI were examined.They were assigned into two groups of non-DILI and DILI.The inter-group differences of basic characteristics and medications were com-pared and the influencing factors of azivudine-induced DILI further discussed.RESULTS Among them,17 cases(5.78％)developed DILI.In clinical classification of DILI,the types were hepatocyte injury(n=4),cholestasis(n=6)and mixed(n=7).Regarding DILI causality assessment,the likelihood was extreme(n=1),quite(n=12)and possible(n=4).As for DILI sever-ity,the grade was Ⅰ(mild,n=10),Ⅱ(moderate,n=5)and unknown(n=2).As for occurrence time of DILI,average treat-ment duration of azvudine was(7.6±3.7)days and occurrence time of DILI(6.4±3.9)days post-dosing.Number of co-medications,hypoproteinemia and critical illness were significant influencing factors for the development of DILI(P＜0.05).CONCLUSION DILI induced by azivudine for COVID-19 is a common clinical adverse reaction.Most adverse reactions are mild or moderate in severity.The overall safety and tolerability of azivudine are decent in clinical practices.The pathological sta-tus of patients should be evaluated prior to clinical dosing.For individuals with hypoproteinemia and/or critically illness,azivudine should be carefully dosed after comprehensive evaluations.During dosing,the number of co-medications should be minimized,especially interacting co-medications should be avoided to avoid the occurrence of DILI.
NETL
NSTL
万方数据
