基于美国FAERS数据库的替妥木单抗相关药品不良事件信号的挖掘与分析OA

OBJECTIVE:To analyze the information of adverse drug events(ADE)related to teprotumumab based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,and to provide reference for safe clinical drug use.METHODS:OpenVigil 2.1 was used to screen and extrac ADE reports of teprotumumab in FAERS database up to the third quarter of 2025.The report odds ratio method,the proportional reporting ratio method,the Bayesian confidence progressive neural network method and the multiple gamma-poisson compression method were adopted to conduct data mining and analysis on the ADE reports related to teprotumumab,and drug alert signals were screened.RESULTS:After deduplication,a total of 5 004 teprotumumab-related ADE reports were collected.Based on the screening of the above four signal detection algorithms,a total of 232 effective signals were obtained,involving multiple system organ classification,mainly including eye organ diseases,ear and labyrinth diseases,reproductive system and breast diseases.A total of 27 new risk signals of teprotumumab-related ADE were mined,in addition to the ADE explicitly mentioned in the drug instructions.The median incubation time of teprotumumab-related ADE was 55 d.CONCLUSIONS:Teprotumumab can cause ADE in multiple organs/systems of the body.It is necessary to be aware of its effects on hearing and female reproductive system in clinical practice.