基于FAERS数据库对ICIs抗肿瘤药物致高血糖不良事件的分析  

Analysis of adverse event of ICIs antineoplastic drugs causing hyperglycemia based upon FAERS database

作　　者：杨丽圆 吴丹珠 闫钰 刘瀛隆 董鹏 王慧 吕亚娟[1] 俞新爽[1] YANG Liyuan;WU Danzhu;YAN Yu;LIU Yinglong;DONG Peng;WANG Hui;LYU Yajuan;YU Xinshuang(Department of Oncology,First Affiliated Hospital,Shandong First Medical University and Shandong Provincial Qianfoshan Hospital,Shandong Jinan 250000,China;Jining Medical College,Shandong Jining 272000,China;Department of Oncology,Second Affiliated Hospital,Shandong First Medical University,Shandong Taian 271000,China)

机构地区：[1]山东第一医科大学第一附属医院(山东省千佛山医院)肿瘤科,山东济南250000 [2]济宁医学院,山东济宁272000 [3]山东第一医科大学第二附属医院肿瘤科,山东泰安271000

出　　处：《中国医院药学杂志》2024年第21期2517-2522,共6页Chinese Journal of Hospital Pharmacy

基　　金：山东医学会临床研究专项(编号:YXH2022ZX02199);白求恩-胰腺肿瘤科研能力建设项目(编号:YXZL-2023-B-001)。

摘　　要：目的:对免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)致高血糖不良事件的数据进行挖掘分析,以此作为临床使用药物的重要依据。方法:利用OpenVigil平台,收集2004年1月1日至2023年6月30日FAERS数据库中ICIs(包括纳武利尤单抗、帕博利珠单抗、阿替利珠单抗、度伐利尤单抗)致高血糖不良事件的报告。采用ROR、PRR和BCPNN法进行信号检测及数据分析。结果:共收集1 020份ICIs致高血糖不良事件的报告,包括纳武利尤单抗648份,帕博利珠单抗287份,阿替利珠单抗72份,度伐利尤单抗13份;其中男性595人,女性347人;报告国家主要是日本和美国。FAERS报告中不良事件以1型糖尿病(type 1 diabetes mellitus,T1DM)、暴发性1型糖尿病(fulminant type 1 diabetes,FT1D)和糖尿病酮症酸中毒(diabetic ketoacidosis,DKA)为主;高血糖的主要不良后果为“危及生命”和“住院时间延长”。结论:ICIs与高血糖的发生相关,其中纳武利尤单抗导致高血糖的风险最高,使用时应注意T1DM、FT1D和DKA的发生。ICIs治疗可能会导致严重的高血糖后果,特别是“危及生命”和“住院时间延长”,临床在应用ICIs时应警惕高血糖严重不良事件。OBJECTIVE To mine the data of adverse event to hyperglycemia caused by immune checkpoint inhibitors(ICIs) and provide references for rational clinical use of drugs.METHODS From January 1,2004 to June 30,2023,OpenVigil platform was utilized for collecting reports of adverse event to hyperglycemic caused by ICIs(including nivolumab,pembrolizumab,atezolizumab & durvalumab) from the FAERS database.Signal detection and data analysis were performed with reporting odds ratio(ROR),proportional reporting ratio(PRR) and Bayesian confidence propagation neural network(BCPNN).RESULTS A total of 1020 reports of adverse event for hyperglycemia caused by ICIs were collected,including nivolumab(n=648),pembrolizumab(n=287),atezolizumab(n=72) and durvalumab(n=13);there were 595 males and 347 females;two major reporting countries were Japan and the United States.The adverse events reported by FAERS were mostly type 1 diabetes mellitus(T1DM),fulminant type 1 diabetes(FT1D) and diabetic ketoacidosis(DKA);The major adverse consequences of hyperglycemia were “life-threatening” and “prolonged hospitalization stay”.CONCLUSION ICIs are associated with the occurrence of hyperglycemia.Navurizumab carries the highest risk of hyperglycemia.When dosing ICIs,clinicians should watch out for the occurrence of type 1 diabetes mellitus(T1DM),fulminant type 1 diabetes mellitus(FTlD) and ketoacidosis(DKA).ICIs treatment may lead to such serious consequences of hyperglycemia as “life-threatening” and “prolonged hospitalization stay”.

关 键 词：免疫检查点抑制剂 高血糖 不良事件报告系统 信号挖掘 

分 类 号：R973[医药卫生—药品]