基于美国FAERS数据库的塞瑞替尼不良事件信号挖掘研究  

Data mining for adverse events signals of ceritinib based on FAERS database

作　　者：罗卫国 蒋亚西 王茂军 LUO Weiguo;JIANG Yaxi;WANG Maojun(Department of Pharmacy,West China-Guang'an Hospital,Sichuan University/Guang'an People's Hospital,Guang'an,Sichuan,638000,China)

机构地区：[1]四川大学华西广安医院/广安市人民医院药剂科,四川广安638000

出　　处：《肿瘤药学》2021年第4期400-405,共6页Anti-Tumor Pharmacy

摘　　要：目的挖掘和分析塞瑞替尼相关不良事件信号,为临床安全合理使用塞瑞替尼提供参考与指导。方法利用比例失衡法和综合标准法(MHRA)对美国FDA不良事件报告系统(FAERS)中2015年第一季度至2020年第二季度共22个季度的塞瑞替尼相关不良事件报告进行数据挖掘和分析。结果获得以塞瑞替尼为首要怀疑药物的不良事件报告总数3539个,共涉及1456例患者,得到不良事件信号151个,累及17个系统器官。塞瑞替尼的不良事件信号主要集中在胃肠系统疾病、各类实验室检查指标异常、肝胆系统疾病、全身性疾病及给药部位各种反应、代谢及营养类疾病、呼吸系统疾病等。此外,本研究也发现了说明书收录不全之处,并挖掘出43个新的不良事件。结论临床使用塞瑞替尼时,相关工作者应做好用药监护和检查,及时采取措施处理不良事件。Objective To mine and analyze the adverse events signals of ceritinib,in order to provide reference and guidance for the safe and rational use of ceritinib in clinical practice.Methods The ceritinib-related adverse event reports from the first quarter of 2015 to the second quarter of 2020 were collected from the US FDA adverse event reporting system(FAERS),and were analyzed by disproportionality measurement and comprehensive methods of Medicines and Healthcare Products Regulatory Agency(MHRA).Results The total number of adverse event reports with ceritinib as the primary suspected drug was 3539,involving 1456 patients.A total of 151 adverse event signals were obtained,and 17 system organ classes(SOCs)were found involved in the adverse events.The adverse event signals of ceritinib mainly focused on the diseases of gastrointestinal system,abnormalities of various laboratory test indicators,hepatobiliary system diseases,systemic diseases and various reactions at the site of administration,metabolic and nutritional diseases,respiratory diseases,etc.In addition,43 new adverse events which were not included in the specifications of ceritinib were also found.Conclusion It is suggested that relevant workers should do well in drug monitoring and examination when ceritinib is used in clinic,and take timely measures to deal with the adverse events.

关 键 词：塞瑞替尼 比例失衡法 药品不良事件 信号挖掘 

分 类 号：R979.1[医药卫生—药品]