摘要
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SPSS 26.0软件对主要累及系统组的ADR例次与其他系统组进行χ^2检验。结果:共收集到塞瑞替尼为首要怀疑药物的ADR报告10318份,挖掘出塞瑞替尼ADR信号236个;排除无效信号后,最终得到ADR信号187个,涉及16个系统。所得信号除药品说明书上提及的外,还包括各类神经系统疾病、血液与淋巴系统疾病、感染和传染性疾病等,如手-足-生殖器综合征、间变淋巴瘤激酶基因突变等。胃肠系统ADR报告最多(576份)。与其他系统ADR比较,患者的性别、年龄、体质量、日剂量、用药疗程对胃肠系统ADR的影响均有统计学意义(P<0.05),其中使用塞瑞替尼后发生胃肠系统ADR的患者多为女性(59.9%)、年龄45岁及以上(70.3%)、体质量≤65 kg(68.1%)、日剂量451~750 mg/d(50.2%)、用药时长3个月以内(75.7%)。结论:45岁以上、体质量低于65 kg的女性患者使用塞瑞替尼后发生胃肠系统ADR的风险较高;此类ADR的发生还与日剂量有关且大多发生在3个月内,临床使用时应加强药学监护。
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.
作者
郑冬妮
周后凤
任常谕
席田兰
ZHENG Dongni;ZHOU Houfeng;REN Changyu;XI Tianlan(Dept.of Pharmacy,Chengdu Fifth People’s Hospital,Chengdu 611130,China)
出处
《中国药房》
CAS
北大核心
2021年第2期236-240,共5页
China Pharmacy
基金
四川省卫生健康委员会科研课题(No.19PJ018)。
