基于美国FAERS数据库的西妥昔单抗不良反应信号挖掘研究  

The Data-Mining of ADR Signals for Cetuximab Based on US FAERS Database

作　　者：陈晨[1,2,3] 夏雪[1,2,3] 蔡毅范 李灏 张臣宇[1,2,3] 刘卢路 王国玉 CHEN Chen;XIA Xue;CAI Yifan;LI Hao;ZHANG Chenyu;LIU Lulu;WANG Guoyu(Labor And Delivery Room,West China Second University Hospital,Sichuan University,Chengdu,Sichuan,610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Chengdu,Sichuan,610041,China;West China School of Pharmacy,Sichuan University,Chengdu,Sichuan,610041,China)

机构地区：[1]四川大学华西第二医院产房,四川成都610041 [2]出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041 [3]四川大学华西药学院,四川成都610041

出　　处：《肿瘤药学》2019年第4期676-681,共6页Anti-Tumor Pharmacy

摘　　要：目的利用美国FDA不良事件报告系统(FAERS)数据挖掘西妥昔单抗的药品不良反应信号,为临床安全合理用药提供参考。方法利用报告比值比(ROR)法和比例报告比值(PRR)法对美国FAERS数据2009年第一季度至2018年第四季度共40个季度的不良事件报告进行数据挖掘。结果使用ROR法获得西妥昔单抗信号619个,将其信号强度按照降序排列获得排名前50位的信号,其中39个未在西妥昔单抗说明书中出现。西妥昔单抗药品说明书未收录的不良反应主要集中于胃肠道损害、代谢和营养障碍。结论既往有胃肠道、肾脏疾病等病史的患者应谨慎使用西妥昔单抗。挖掘和评价基于美国FAERS数据库获得的西妥昔单抗不良反应相关信号,可为其临床合理应用提供依据。Objective To mine the adverse drug reaction(ADR)signals of cetuximab by employing the data from US FDA Adverse Event Reporting System(FAERS),and to provide reference for clinic safe and rational drug use.Methods Measures of disproportionality were applied to carry on data-mining of the data from FAERS,from the first quarter in 2009 to the fourth quarter in 2018,40 quarters in total.Results A total of 619 cetuximab signals were obtained by using reporting odds ratio(ROR),and the signal strength was ranked in descending order to get the top 50 signals,39 of which did not appear in the specification of cetuximab.The adverse reactions of cetuximab not included in the specification were mainly focused on gastrointestinal damage,metabolic and nutritional disorders.Conclusion Results suggested that patients with previous history of gastrointestinal damage and kidney disease should be alert to potential adverse reactions when getting this drug.The mining and evaluation of FAERS can get cetuximab ADR signals,and such signals could provide the basis for rational clinical use.

关 键 词：西妥昔单抗 不良反应信号 比例失衡法 

分 类 号：R[医药卫生]