BTKI不良反应评估:基于FAERS数据库的研究和分析
BTKI adverse reaction evaluation:Research and analysis based on FAERS database
陈颖 1初晓玲 1高茗1
作者信息
- 1. 210002 南京,南京大学医学院附属金陵医院(东部战区总医院)药剂科
- 折叠
摘要
目的 发掘比较新的不良反应,为临床个性化方案的选择和安全提供依据.方法 提取FAERS数据库中2013年第四季度到2023年第三季度的相关信息,通过比例失衡法对3种BTK抑制剂的不良事件进行分析,采用报告比值比法和综合标准法,识别信号.结果 伊布替尼在耳以及迷路疾病的信号较强,泽布替尼在皮肤以及皮下组织类疾病信号较强,阿卡替尼在血液以及淋巴系统疾病信号较强,且发现了一些说明书中未提及的不良事件.结论 BTK抑制的不良反应有一定的共性,但各有特点,在选择以及用药期间应根据患者的生理状态进行个性化的选药和监测.
Abstract
Objective To explore the new adverse reactions and provide the basis for the selection and safety for the individu-ally clinical plans.Methods Relevant information was extracted from the FAERS database from the fourth quarter of 2013 to the third quarter of 2023,and the adverse events of three BTK inhibitors were analyzed using the disproportionality analysis.In this study,the reporting odds ratio method and MHRA were used to identify signals.Results Ibrutinib has strong AE signals in ear and labyrin-thine diseases,Zanubrutinib has strong AE signals in skin and subcutaneous tissue diseases,Acalabrutinib has strong AE signals in blood and lymphatic system diseases,and some adverse events not mentioned in the instructions were found.Conclusion The ad-verse reactions of BTK inhibition have certain commonalities,but each has its own characteristics.Individualized drug selection and monitoring should be based on the patient's physiological status during the selection and medication period.
关键词
布鲁顿氏酪氨酸激酶/不良事件/不良事件报告系统Key words
Bruton's tyrosine kinase/adverse events/FAERS引用本文复制引用
出版年
2024
NETL
NSTL
万方数据