塞瑞替尼不良反应信号挖掘与分析

目的:初步评价塞瑞替尼上市后的安全性,为临床合理用药提供参考.方法:采用报告比值比法(ROR)和比例报告比法(PRR)对美国FDA不良事件报告系统(FAERS)中2014年第2季度至2019年第3季度塞瑞替尼的不良反应(ADR)进行信号挖掘,收集主要累及系统ADR报告相关患者的性别、年龄、体质量、日剂量、用药疗程,利用...

ADR Signal Mining and Analysis of Adverse Drug Reaction of Ceritinib

OBJECTIVE:To initially evaluate the safety of ceritinib after it is marketed,and to provide reference for the rational use of drug.METHODS The report odd ratio method and proportional reporting ratio method were used to mine the signals of ceritinib-related adverse events from FDA adverse event reporting system(FAERS)during the second quarter of 2014 to the third quarter of 2019.The patients’gender,age,body weight,daily dose and course of treatment were collected.SPSS 26.0 software was used to test the number of ADR cases of this system group and other system groups by chi square test.RESULTS:A total of 10318 ADR reports with ceritinib as the first suspicious drug were collected,and 236 ADR signals of seretinib were excavated.After excluding the ineffective treatment,187 ADR signals were obtained,involving 16 systems.Inaddition to those mentioned in the drug instructions,the signals also included various nervous disease,blood and lymph system disease,infections and infectious disease,etc.,such as hand-foot-genital syndrome,mutation of anaplatic lymphoma kinase gene.Among them,the ADR reports of gastrointestinal diseases were the most(576 cases).Compared with ADR of other systems,gender,age,body weight,daily dose and treatment course had significant effects on ADR of gastrointestinal diseases(P<0.05).Most of the patient with gastrointestinal ADR after using ceritinih were female(59.9%),45 years old and above(70.3%),body weight≤65 kg(68.1%),daily dose 451-750 mg/d(50.2%),and medication duration less than 3 months(75.7%).CONCLUSIONS:The risk of gastrointestinal ADR in female patients over 45 years old and with body weight less than 65 kg after using seretinib is relatively high.This kind of ADRs are also related to daily dose,and most of which occur within 3 months.Therefore,great importance should be attached to drug monitoring during clinical use.