Signal mining and analysis of adverse events of tilposide based on FAERS database
Objective To explore the risk signals of tilposide related adverse events in FEARS database,and comprehensively evaluate the safety of the drug in clinical application.Methods The adverse events reports of tilposide from the second quarter of 2022 to the third quarter of 2024 in FAERS database were collected.The reported odds ratio(ROR)method and Bayesian confidence interval progressive neural network(BCPNN)method were used for data analysis,and the system organ classification(SOC)and preferred term(PT)in the International Dictionary of medical terms(MedDRA)adverse drug reaction terminology set were used for standardized sinicization and classification statistics.Results A total of 47 306 adverse events reports with tilposide as the primary suspected drug were extracted.After ROR method and BCPNN method were used to detect,178 PTs involving 20 SOC were finally obtained after excluding signals unrelated to the drug,such as product problems,various injuries,poisoning,and operation complications.PT includes common adverse events such as discomfort at the injection site,followed by nausea,constipation,pancreatitis,etc,and serious adverse events:thyroid cancer.Adverse events not mentioned in the instructions were also detected,such as elevated levels of calcitonin,cortisol,and heavy menstrual bleed.In addition,we used Weber distribution test to analyze the occurrence time(TTO)of tilposide ade,and found that the median tto of adverse events was 28 days,and the interquartile range was 7 to 92 days.Most cases occurred within 30 days after tilpotide administration(52.44%).Conclusion In addition to the common adverse reactions mentioned in the instruction manual of tilposide,this study also found new and serious adverse reactions of tilposide,which is helpful for the clinical monitoring and risk identification of ADE after tilposide administration,and ensures the clinical safety of drug use.
tilposideadverse eventssignal miningdiscomfort at the injection sitethyroid cancer
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