Objective To explore the risk signals of amphotericin B deoxycholate(AmB-D)and amphotericin B liposome(L-AmB)by using FAERS database,to provide reference for clinical rational drug use.Methods Adverse event reports of AmB-D and L-AmB from the first quarter of 2004 to the fourth quarter of 2023 were extracted based on FAERS database and imported into SAS 9.4 software for data cleaning and analysis.The adverse event signal mining was performed by ROR,PRR,MHRA,and BCPNN.Results Adverse drug event reports of AmB-D and L-AmB were 1 308 and 4 304,respectively.The most frequent adverse drug event of the two drugs were hypokalemia and acute kidney injury.It was found that the proportion of adverse event reports for renal and urinary diseases was similar between AmB-D and L-AmB,suggesting that the nephrotoxicity of liposomes may be underestimated in clinical practice.The suspected adverse event signal of AmB-D was found to be immune reconstructive inflammatory syndrome and white matter disease.The suspicious signals of L-AmB are toxic epidermal necrolysis,immune reconstitution inflammatory syndrome,elevated β2 microglobulin,spleen damage and intravascular hemolysis,which are not indicated in the instructions and should be paid attention to.Conclusion The mining of AmB-D and L-AmB suspected adverse event signals was mostly consistent with those recorded in the manual,but new signals were still found,which required active monitoring.
amphotericin B deoxycholateamphotericin B liposomeadverse drug reactionssignal mininghypokalemia
NETL
NSTL
万方数据
