基于FAERS数据库的枸橼酸伊沙佐米胶囊安全信号挖掘研究  

Mining and analysis of ixazomib citrate capsules safety signals based on FAERS database

作　　者：郝晓慧 张萍 武璐璐 王丽华 HAO Xiaohui;ZHANG Ping;WU Lulu;WANG Lihua(The Fifth Medical Centre,Chinese PLA General Hospital,Beijing 100071,China)

机构地区：[1]中国人民解放军总医院第五医学中心药剂科,北京100071

出　　处：《中国药物警戒》2023年第12期1427-1431,共5页Chinese Journal of Pharmacovigilance

基　　金：军队医药卫生科技成果扩试项目(BWS11J049);后勤科研项目(CWS14J072)。

摘　　要：目的挖掘分析枸橼酸伊沙佐米胶囊(简称“伊沙佐米”)上市后潜在的不良事件(AE)风险信号,为其临床合理使用提供参考。方法提取美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中伊沙佐米从2015年11月上市到2023年3月31日的AE报告,并对数据进行清洗去重和标准化。采用报告比值法(ROR)和贝叶斯置信度递进神经网络法(BCPNN)进行AE信号挖掘。结果在数据库中以伊沙佐米为首要怀疑的AE报告共14156例。经ROR法和BCPNN法进行检测筛选,获得204个有效首选术语(PT)信号,累及17个系统-器官分类(SOC)。与说明书进行比对发现,说明书未记载的PT信号有156个,新发比较严重AE信号为死亡、心血管系统、肾脏及泌尿系统等,临床需给予高度关注。结论对伊沙佐米真实世界的不良事件进行挖掘,提示临床需慎重评估伊沙佐米AE危险因素,加强用药监护,保障患者用药安全。Objective To mine and analyse the potential adverse event(AE)risk signals of ixazomib citrate capsules postmarketing to provide a reference for its rational clinical application.Methods Extract the FAERS database of AE reported for Ixazomib citrate capsules from marketing(November 2015)to March 31,2023,data cleaning and de-duplication and standardization.Signal mining was performed using the Reported Ratio(ROR)and Bayesian Confidence Progressive Neural Network(BCPNN)methods.Results A total of 14156 AE were reported in the database with Ixazomib citrate capsules as the primary suspect.Mining by ROR and BCPNN methods resulted in 204 potential positive PTs,involving 17 SOC.Among them,there are 156 PT signals that are not specified in drug instruction,including the new and relatively serious AE such as death,cardiovascular system and renal-urinary system,which require high clinical attention.Conclusion Mining the real-world adverse events of ixazomib citrate capsules suggests that the clinical caution in evaluating its AE risk factors and strengthening the medication monitoring to ensure the safety of the medication for the patients.

关 键 词：枸橼酸伊沙佐米胶囊 蛋白酶体抑制剂 信号挖掘 FDA不良事件报告系统 药品不良事件 

分 类 号：R994.11[医药卫生—毒理学] R979.1[医药卫生—药学]