Signal mining of respiratory adverse events caused by trastuzumab deruxtecan based on the FDA adverse event reporting system database
Objective To mine and analyze respiratory adverse event signals caused by trastuzumab deruxtecan based on the FDA adverse event reporting system(FAERS)database,and to provide reference for clinical safety of drug use.Methods This study analyzed real-world data on respiratory adverse events associated with trastuzumab deruxtecan reported in the FAERS database from Q1 2020 to Q1 2023.The reported odds ratio of the proportional disequilibrium method,and the United King-dom's Medicines and Healthcare Products Regulatory Agency(MHRA)were used to identify adverse event signals.Results A to-tal of 4944 signals for adverse events associated with trastuzumab deruxtecan were retrieved,of which 702(14.20%)were relat-ed to respiratory adverse events.Stronger signals were observed for interstitial lung disease,lung inflammation,pleural effusion,lung disease,and pulmonary embolism.Although elevated KL-6,bacterial pneumonia,and COVID-19 were not mentioned in the specification,they still had a high correlation.Conclusion Respiratory adverse events associated with trastuzumab deruxtecan are common,with interstitial lung disease having a high mortality rate.Clinical attention should also be paid to respiratory-related adverse events such as elevated KL-6 and bacterial pneumonia.Lung monitoring needs to be strengthened during medication.
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