Objective To explore adverse event(AE)signals of sunitinib and to provide a reference for rational drug monitoring based on the Food and Drug Administration Adverse Event Reporting System(FAERS)database.Methods Report odds ratio method(ROR),proportional report ratio method(PRR),polynomial gamma Poisson distribution reduction method(MGPS),and Bayesian confidence interval progressive neural network method(BCPNN)were used to detect the data risk signal strength of sunitinib from the first quarter of 2006 to the third quarter of 2023.Results A total of 35 720 AE reports of sunitinib were retrieved,with 310 positive signals.Most AEs occurred in the first 30 days after treatment(39.71％).Serious AE accounted for 76.37％;27 system organ classifications(SOCs)were involved in positive signals,and the top three were systemic diseases,various reactions at the administration site,gastrointestinal system diseases,and various examinations.High frequency of death,diarrhea,disease progression,and fatigue;65％of the top 20 AEs were new adverse reactions,such as tumor rupture and diffuse proliferation of uveal melanocytes.Conclusion The evaluation of sunitinib should be improved,and medication monitoring should be strengthened to ensure the safety of patients.
关键词
舒尼替尼/不良事件/美国食品药品管理局不良事件报告系统/信号挖掘
Key words
Sunitinib/Adverse events/Food and Drug Administration Adverse Event Reporting System(FAERS)database/Signal mining
维普
万方数据