基于美国FAERS数据库对西米普利单抗不良事件的分析  

Analysis of adverse drug events of cemiplimab based on FAERS database

作　　者：卢渭金 朱泽凤 黄李梧 严考铃 吴晓松[1] LU Wei-jin;ZHU Ze-feng;HUANG Li-wu;YAN Kao-ling;WU Xiao-song(Department of Pharmacy,The Fifth Affiliated Hospital of Jinan University,Heyuan 517000,China)

机构地区：[1]暨南大学附属第五医院药学部,广东河源517000

出　　处：《中国药物应用与监测》2023年第6期437-440,共4页Chinese Journal of Drug Application and Monitoring

基　　金：广东省医学科学技术研究基金项目(A2022549)。

摘　　要：目的:挖掘西米普利单抗的药品不良事件(ADEs)风险信号,为其后续在临床免疫治疗安全性方面提供参考。方法:基于美国FDA药物不良事件报告系统(FAERS)数据库,收集2018年9月28日-2023年3月31日西米普利单抗ADEs报告。采用比例失衡测量法对西米普利单抗的ADEs风险信号进行挖掘、分析;对首选术语(PT)和系统器官类(SOC)进行描述和分类。结果:筛选出642份以西米普利单抗为首要怀疑药物的ADEs报告,挖掘出79个PT,累及20个SOC。常见的ADEs包括皮疹、感染性肺炎、全身状况恶化、发热和脓毒症等,主要涉及免疫系统疾病(10.20%)、各类损伤、中毒及操作并发症(10.20%)、呼吸系统疾病胸及纵隔疾病(8.16%)等。而出血、间质性肺疾病、吞咽困难、肝酶升高、颅腔积气、嗜酸粒细胞增多性筋膜炎、股骨颈骨折以及液体摄入下降等ADEs信号均未载入该药的药品说明书。结论:西米普利单抗在上市后临床应用中常见免疫相关不良反应发生情况与药品说明书基本一致;新的可疑ADEs风险信号如出血、间质性肺疾病、吞咽困难等,需要重点关注。Objective:To explore the risk signals of adverse drug events(ADEs)of cemiplimab for its clinical safe application.Methods:Openvigil 2.1 was sourced from the U.S.Food and Drug Administration’s Adverse Event Reporting System(FAERS)database.The ADEs reports of cimiplimab were collected through Openvigil 2.1 database from September 28th,2018 to March 31th,2023.The reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were applied to analyze the ADEs risk signals of cemiplimab.The preferred term(PT)and system organ class(SOC)were described and classified by the Medical Dictionary for Regulatory Activitie(version 24.0)(MedDRA 24.0).Results:A total of 642 ADEs reports with cemiplimab as the primary suspected drug were collected,and 79 PT signals and 20 SOCs were obtained.Common ADEs included rash,pyrexia,general physical health deterioration and sepsis,etc.,and they were mainly related to immune system diseases(10.20%),various injuries,poisoning as well as operational complications(10.20%)and respiratory system diseases,chest and mediastinal diseases(8.16%),etc.The adverse reaction signals such as haemorrhage,interstitial lung disease,dysphagia,hepatic enzyme increase,pneumocephalus,eosinophilic fasciitis,femoral neck fracture and fluid intake reduction were not mentioned in the drug instructions of cemiplimab among the top of 20 PT reports and 20 signal intensities.Conclusion:The incidence of immune-related adverse reactions in clinical application of cemiplimab are basically consistent with the drug instructions.In addition to the ADEs recorded in the drug instructions,attention should also be paid to the risks of haemorrhage,interstitial lung disease,dysphagia in clinical application of cemiplimab.

关 键 词：西米普利单抗 药品不良事件 药物警戒 数据挖掘 

分 类 号：R969.3[医药卫生—药理学]