基于FAERS数据库的罗氟司特片不良事件数据挖掘与分析OA

OBJECTIVE:To perform the post-marketing safety re-evaluation on Roflumilast tablets based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,to identify the actual risks associated with the use in the real world,and to provide reference for safe clinical medication.METHODS:Adverse events(AEs)reports related to Roflumilast tablets from the U.S.FAERS database(from 2011 to 2025)were extracted.Four algorithms such as report odds ratio,proportional report ratio,Bayesian belief propagation neural network and multi-item Gamma Poisson constrictor were used for signal mining.Subgroup analysis and time-to-onset analysis were performed concurrently.RESULTS:A total of 3,276 AEs reports for Roflumilast tablets were included,with the highest proportion of AEs reports in men≥65 years of age.Most AEs occurred within the first 30 d of Roflumilast tablets admonistration.These events involved 26 system organ classes and yielded 63 potential targets identified through four screening methods.This study identified several new AEs signals,including Barrett's esophagus,gastric ulcers,gastroduodenal ulcers,and arrhythmias,which were not documented in drug instructions or existing literature.CONCLUSIONS:This study represents the first post-marketing safety analysis of Roflumilast tablets based on the U.S.FAERS database.The new adverse drug reactions not recorded in the drug instructions are worthy of attention,and the relevant conclusions provide important risk basis for its clinical safe application.