基于美国FAERS数据库的克唑替尼不良事件信号挖掘与分析OACSTPCD

OBJECTIVE:To explore the adverse events(ADE)signals of crizotinib,so as to provide reference for medication safety in the clinic.METHODS:Reports of crizotinib-related ADE were collected from the US Food and Drug Administration Adverse Event Reporting System(FAERS)database from Aug.26th,2011 to Mar.31st,2023.Reporting odds ratio(ROR)method and medicines and healthcare products regulatory agency method(MHRA)were used for data mining.The preferred system organ classification(SOC)and preferred terminology(PT)in the ICH Medical Dictionary for Regulatory Activities(MedDRA)were used to describe,classify and analyze ADE.RESULTS:A total of 22493 ADE reports related to crizotinib were retrieved.Most of the patients were male(11862 cases,52.74%)and were≥65 years old(109 cases,0.48%).The main reporting country was the United States(12837 cases,57.07%).A total of 18370 severe ADE were involved,mainly for hospitalization(4595 cases,accounting for 25.01%of the total number of severe ADE).A total of 61453 ADE signals were detected,including 15 kinds of SOC,which were mainly systemic diseases,various reactions at the drug administration site,and gastrointestinal functional diseases.ADE signals with the highest ranked number of reported cases were related to PT such as death,diarrhea,nausea and fatigue.ADE signals with the highest ranked signal intensity were related to PT such as soft tissue sarcoma,malignant connective tissue tumor,and metastatic synovial sarcoma.CONCLUSIONS:ADE induced by crizotinib mainly includes systemic abnormalities,gastrointestinal reactions,abnormalities of various examination indicators.Before the application of crizotinib,clinical evaluation should be done,and the blood indicators and systemic response of patients should be focused on during treatment to ensure the safety of treatment.