基于FAERS数据的眼内注射用雷珠单抗和阿柏西普不良事件对比分析  

Comparative Analysis of Adverse Events in Ranibizumab and Aflibercept for Intraocular Injection Based on FAERS

作　　者：兰忠玲 姚晖 吴皓[2] 李晓莹 曹文荣[2] 古筱茹 LAN Zhongling;YAO Hui;WU Hao;LI Xiaoying;CAO Wenrong;GU Xiaoru(School of Pharmacy,Zunyi Medical University,Zunyi,Guizhou 563000,China;Division of Clinical Pharmacy,Foshan Second People's Hospital,Foshan,Guangdong 528000,China)

机构地区：[1]遵义医科大学药学院,贵州遵义563000 [2]佛山市第二人民医院临床药学科,广东佛山528000

出　　处：《今日药学》2024年第6期442-450,共9页Pharmacy Today

基　　金：广东省医院药学研究基金(澳美基金,2023A26);佛山市“十四五”医学高水平重点专科建议项目(FSGSP145068)。

摘　　要：目的利用美国不良事件报告系统(FAERS)数据对眼内注射用雷珠单抗和阿柏西普两种药物的相关不良事件(ADE)信号进行挖掘与整体比较分析,为治疗新生血管性眼底疾病临床安全用药提供参考。方法收集FAERS中2004~2022年共76个季度与雷珠单抗和阿柏西普相关的ADE报告,运用SQL语言去除重复数据后,采用国际医学用语(MedDRA)词典对ADE进行标准化处理与分类。利用报告比值比法、比例报告比值法和贝叶斯法对ADE报告进行数据挖掘,分析两个药物ADE信号差异,并与药品说明书对比获得新的ADE信号。结果以雷珠单抗为首要怀疑药物的ADE报告共21175份,阿柏西普则有21764份。雷珠单抗和阿柏西普ADE累及系统大致相似,50%以上ADE为眼器官疾病,其次以神经系统ADE为主。共挖掘出678个ADE信号(其中雷珠单抗402个,阿柏西普276个),雷珠单抗比阿柏西普在视网膜色素上皮撕裂、视网膜水肿和玻璃体出血眼部ADE方面信号强度和频次更高,而阿柏西普在眼内炎、非感染性眼内炎、玻璃体炎等9个ADE方面则比雷珠单抗高,两种药物的高危信号存在差异性。与药品说明书对比,挖掘出两药存在视网膜下积液,玻璃体切割术、死亡等新的ADE信号。结论FAERS数据库显示两药ADE整体分布基本一致,但两药的安全性各有优劣。建议临床上使用雷珠单抗应重点监测视网膜相关ADE,阿柏西普重点关注眼部感染和全身性ADE,尤其对本次挖掘出的新的ADE应引起重视。OBJECTIVE To mining and comparative overall analysis of adverse event(ADE)signals associated with both intraocular injectable ranibizumab and aflibercept using the US FDA Adverse Event Reporting System(FAERS)data,providing a reference for clinical safe medication in the treatment of neovascular fundus disorders.METHODS ADE reports relative to ranibizumab and aflibercept from 2004 to 2022 were collected for a total of 76 quarters in the FAERS,and after removing duplicate data using SQL language,ADEs were standardized and categorized using the Medical Dictionary for Drug Regulatory Activities(MedDRA).Data mining of ADE reports was performed using the reporting odd ratio method,proportional reporting ratio method and the Bayesian method to analyze the differences in adverse event signals between the two drugs and to obtain new ADE signals by comparing them with the drug package inserts.RESULTS There were a total of 21175 ADE reports for ranibizumab as the primary suspect drug and 21764 ADE reports for aflibercept.Ranibizumab and aflibercept ADEs involved roughly similar systems,with more than 50%of ADEs being ocular organ disorders,followed by nervous system ADEs.Totally 678 ADE signals were mined(including 402 of ranibizumab and 276 of aflibercept),ranibizumab has a higher signal intensity and frequency of ADE in retinal pigment epithelial tears,retinal edema and vitreous hemorrhage ocular ADEs compared to aflibercept,while aflibercept was higher than ranibizumab in nine ADEs,including endophthalmitis,noninfectious endophthalmitis,and vitreous inflammation,and the high risk signals for the two drugs existence of variability.Compared with the drug package inserts,new ADE signals of the presence of subretinal fluid,vitrectomy,and death were discovered in the two drugs.CONCLUSION The FAERS database showed that the overall distribution of ADEs of the two drugs was basically consistent,but the safety of the two drugs had their own advantages and disadvantages.It is recommended that the clinical use of ranibizumab should

关 键 词：雷珠单抗 阿柏西普 药品不良事件 报告比值比法(ROR) 比例报告比值法(PRR) 贝叶斯法 信号挖掘 

分 类 号：R969[医药卫生—药理学]