基于FAERS数据库的酪氨酸激酶抑制剂致药品不良反应信号的挖掘与分析  

Mining and Analysis of Adverse Drug Reaction Signals Induced by Tyrosine Kinase Inhibitors Based on FAERS Database

作　　者：王少霞 陈娇娇 高婷 赵泉[2] 霍雪臣[2] WANG Shaoxia;CHEN Jiaojiao;GAO Ting;ZHAO Quan;HUO Xuechen(College of Pharmacy,Yantai University,Shandong Yantai 264003,China;Dept.of Pharmacy,Yantai Yuhuangding Hospital,Shandong Yantai 264000,China)

机构地区：[1]烟台大学药学院,山东烟台264003 [2]烟台毓璜顶医院药学部,山东烟台264000

出　　处：《中国医院用药评价与分析》2023年第4期498-501,505,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：山东省药学会医院药学专项科研学术活动项目(No.yyyx2021qn-13)。

摘　　要：目的:基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库,对伊马替尼、尼洛替尼和达沙替尼等3种酪氨酸激酶抑制剂(TKI)进行药品不良反应(ADR)信号挖掘,为临床合理用药提供有效参考。方法:采用报告比值比法(ROR)和比例报告法(PRR),对3种TKI类药物自上市以来至2022年3月31日FAERS数据库中收到的ADR报告进行挖掘分析,并进行二次筛选,得到有效信号后,利用国际医学用语词典(MedDRA)术语集进行汉化及系统归类。结果:3种TKI类药物共得到538个ADR信号,累及器官和(或)系统20个;其中伊马替尼涉及249个信号(27075例ADR报告),主要集中于全身性疾病及给药部位各种反应;尼洛替尼涉及183个信号(9478例ADR报告),主要集中于各类检查;达沙替尼涉及106个信号(7053例ADR报告),主要集中于呼吸系统、胸及纵隔疾病。结论:3种TKI类药物之间的ADR具有差异性,临床使用时,应根据患者情况实现个体化给药,提高用药安全性。OBJECTIVE:To explore the adverse reaction(ADR)signals of three kinds of tyrosine kinase inhibitor(TKI)drugs such as imatinib,nilotinib and dasatinib based on FDA adverse event reporting system(FAERS),so as to provide reference for clinical safe medication.METHODS:Reported odds ratio(ROR)and proportional report ratio(PRR)methods were used to analyze the ADR reports received from the FAERS database of three kinds of TKI drugs from the marketing to Mar.31,2022.After secondary screening,effective signals were obtained.The International Medical Terminology Dictionary(MedDRA)was used to translate and classify the Chinese version.RESULTS:A total of 538 ADR signals were obtained from three kinds of TKI drugs,and 20 organs and(or)systems were involved.Imatinib involved 249 signals(27075 ADR reports),mainly covered on systemic diseases and various reactions at the administration site.Nilotinib involved 183 signals(9478 ADR reports),mainly covered on various examinations.Dasatinib involved 106 signals(7053 ADR reports),mainly covered on respiratory system,thoracic and mediastinal diseases.CONCLUSIONS:There are certain differences among ADR of three kinds of TKI drugs.The clinical use should be individualized according to the patients’condition to improve the safety of drug use.

关 键 词：酪氨酸激酶抑制剂 药品不良反应 FAERS 信号挖掘 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]