Objective To conduct an analysis based on the U.S.food and drug administration adverse event reporting system(FAERS)to mine the adverse drug event signals of the ultrasound contrast agent sulphur hexafluoride,and to provide the reference for safe clinical use.Methods All reported sulphur hexafluoride adverse drug event reports(ADE)from 2015 to 2023 in the FAERS database were extracted,and the ADE were analyzed by the report-to-ratio(ROR)method,the proportionate report-to-ratio(PRR)method,the Bayesian confidence propagation neural network(BCPNN)method,the empirical Bayesian geometric mean(EBGM)algorithm,and the ADE that not labelled in the instructions were explored.Results A total of 12 178 164 ADE from the FAERS database were extracted.Of these ADE,sulphur hexafluoride was identified as the main suspected drug in 1079 ADE.Patient gender was predominantly male(56.35%)and reported nationality was predominantly American(86.28%).The resulting ADE were mainly for 16 system-organ classifications,with various neurological disorders,systemic disorders and various reactions at the site of administration,respiratory system,immune system disorders,and cardiac organ disorders being the main ones,and the ADE risk signals were generally consistent with the drug instructions.While adverse reactions not included in the instructions were extracted,including eye organ diseases,renal and urinary system diseases,ear and labyrinthine disorders and infections and invasive diseases(ROR=0.61,0.36,0.72,0.03),but the high risk signals were low.Severe ADE outcomes were mostly life-threatening(23.2%)and hospitalisation(23.04%),and there were 4.69%of fatal ADE.Conclusion Contrast agent sulphur hexafluoride is relatively safe,and the actual application of some of the instructions are not included in the adverse reactions,and it is recommended that contraindications,precautions,and supervision should be strictly grasped in the process of actual clinical application.
Sulfur hexafluorideFAERS databaseAdverse drug events
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NSTL
万方数据
