Data Mining Study On Risk Signal Of Triazole Antifungal

Objective: based on the adverse event data of the US Food and Drug Administration,this study established a triazole antifungal adverse event database,excavated the adverse event data,found new risk signals,provided reference for clinical safe medication,and promoted The rational use of azole antifungal drugs.Method: obtain and analyze the original data containing adverse events of triazole antifungal drugs,perform data cleaning,standardize drug names and data integration,and establish a database for risk signal data mining research.Define ‘important adverse events' and ‘serious adverse events',then the ‘major adverse events',‘serious adverse events' and ‘adverse events' in the drug specification of triazole antifungal drugs were analyzed by using the Reporting Odds Ratio in the Disproportionality Analysis.The‘serious adverse events' not recorded in the drug specifications were taken as new risk signals.Result: through the data mining of adverse events database of triazole antifungal drugs,we found that for important organs,fluconazole has 75 important risk signals,itraconazole has 30 important risk signals,voriconazole has 79 important risk signals,posaconazole has 33 important risk signals.The adverse events recorded in the drug specifications were compared with the data mining results,and it was found that there were 13 positive signals in fluconazole,14 positive signals in itraconazole,38 positive signals in voriconazole,13 positive signals in posaconazole,and the percentage of adverse events as risk signals in the description of four kinds of triazole antifungal drugs was 20.97%,16.28%,25.33%,15.67%.For serious adverse events,the study finally found 6 new risk signals of fluconazole,2 new risk signals of itraconazole,8new risk signals of voriconazole,11 new risk signals of posaconazole.These new risk signals were not recorded in the existing specifications.Conclusion: through the data mining of adverse drug events,four triazole antifungal drugs,fluconazole,itraconazole,voriconazole and posaconazole,have more risk signals in the heart,blood,gastrointestinal,liver and kidney and other important organs or systems;some adverse events have not been recorded in the drug instructions,which are new drug risk signals,and these new risk signals need to be monitored with additional attention.It is necessary to evaluate the use of triazoles in clinical antifungal therapy in order to reduce the risk of adverse drug events.