基于 FAERS 数据库的艾塞那肽微球不良事件信号挖掘与研究.

Objective To explore the risk signals of adverse events (ADE) in the use of exenatide microspheres by the FDA adverse event reporting system (FAERS), and provide reference for clinical rational drug use and drug safety. Methods With exenatide microspheres as the target drug, the search keywords were Exenatide Microspheres for Injection, LY05006, AC 2993 LAR and Bydureon. SAS software was used to extract the ADE report data from January 2, 2012 to March 31, 2023 in the FAERS database and the duplicates were removed. Data mining of exenatide microspheres-related ADE reports was performed by the reporting odds ratio method and the comprehensive standard method. Results A total of 27 248 exenatide microspheres-related ADE reports were retrieved, involving 27 SOCs, of which 4 719 were severe ADE reports. The reporting personnel were mainly consumers (18 435 cases，67.66%), the United States was the mainly reporting country (26 295 cases，96.50%) . A total of 163 ADE risk signals were obtained by reporting odds ratio method and comprehensive standard method, including new adverse reactions such as abnormal blood cholesterol, elevated lipase and mixed hyperlipidemia. Conclusion Based on the FAERS database, the post-marketing ADE of exenatide microspheres was mined and analyzed, which could provide reference for clinical medication safety and improvement of patients' medication compliance. [ABSTRACT FROM AUTHOR]