基于FAERS数据库的卡非佐米安全警戒信号挖掘与分析  

Mining and analysis of security alert signals of carfilzomib based on FAERS

作　　者：韩俊萍 沈珠[1] 顾睿洋 李跃东 HAN Junping;SHEN Zhu;GU Ruiyang;LI Yuedong(Department of Pharmacy,the Second Affiliated Hospital of Suzhou University,Jiangsu Suzhou 215000,China;Exigen Services Suzhou Co.,Ltd,Jiangsu Suzhou 215028,China)

机构地区：[1]苏州大学附属第二医院药学部,江苏苏州215000 [2]益进信息苏州有限公司,江苏苏州215028

出　　处：《中国医院药学杂志》2023年第18期2081-2087,共7页Chinese Journal of Hospital Pharmacy

基　　金：苏州市民生科技-医疗卫生应用基础研究项目(编号:SYSD2020182)。

摘　　要：目的:基于美国FDA不良事件报告系统(FAERS)对卡非佐米的不良反应进行挖掘,为临床安全用药提供参考。方法:收集FAERS数据库2012年3季度至2022年4季度共42个季度的数据,采用报告比值比法(ROR)和比例报告比值法(PRR)进行数据挖掘。结果:共提取到卡非佐米相关不良事件报告记录16229例,男女比例为1.27∶1,患者中位年龄为65岁,小于18岁患者165例。美国、德国和法国是报告例数最多的前3位国家。单用卡非佐米患者8330例,合并用药中联合地塞米松的患者5340例。挖掘出卡非佐米不良事件信号688个,排除非药品不良反应信号后得到信号620个,累及20个器官系统。395个信号在现有药品说明书中未被提及,信号强度排名前50位的首选术语中未在说明书中出现的信号共34个,包括全身炎症反应综合征、软骨病、浆细胞骨髓瘤、室壁运动指数异常、关节强直等。卡非佐米联用地塞米松患者发生率较高的不良反应包括浆细胞骨髓瘤、血小板减少、肺炎、中性粒细胞减少等。结论:利用FAERS数据库可较深入挖掘分析卡非佐米安全警戒信号,为临床安全合理用药提供参考。使用卡非佐米期间应注意监测血液毒性、肾功能、血压波动、肿瘤溶解综合征、肺部情况,保障患者用药安全。OBJECTIVE Based on the FDA Adverse Event Reporting System(FAERS)in the United States,to explore the adverse reactions of carfilzomib and provide reference for clinical safe medication.METHODS The data of carfilzomib-induced ADR were collected from FAERS database during the third quarter of 2012 to the forth quarter of 2022.The reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method were used for data mining.RESULTS A total of 16229 cases of adverse events related to carfilzomib were reported.The ratio of male-to-female with adverse events was 1.27 and the median age was 65 years old.165 cases of patients younger than 18 years old were reported.The US,Germany and France were top three countries with the most reported cases.There were 8330 patients who were treated with carfilzomib alone,and 5340 patients who were treated with carfilzomib in combination with dexamethasone.A total of 688 adverse events signals were detected,with 620 signals were obtained after excluding non-drug adverse event signals,involving 20 systems.395 signals were not mentioned in the existing drug instructions.Among the top 50 preferred terms in signal intensity,34 signals were not included in the instructions,including systemic inflammatory response syndrome,chondropathy,plasma cell myeloma,wall motion score index abnormal,joint ankylosis,etc.ADR with high incidence in patients treated with carfilzomib and dexamethasone included plasma cell myeloma,thrombocytopenia,pneumonia,neutropenia,etc.CONCLUSION The FAERS database can be used to mine and analyze the safety warning signals of carfilzomib,and provide reference for clinical safe and rational use of drugs.Blood toxicity,renal function,blood pressure fluctuation,tumor lysis syndrome and lung condition should be monitored during the use of carfilzomib to ensure the safety of patients.

关 键 词：卡非佐米 FAERS数据库 不良反应 信号挖掘 

分 类 号：R979.19[医药卫生—药品]