贝伐珠单抗眼部用药相关不良事件回顾性研究  

Retrospective Study on Adverse Events Related to Bevacizumab Eye Medication

作　　者：孙冠男 陈礼怡 何明珠 张焜 颜久兴[2] SUN Guan-nan;CHEN Li-yi;HE Ming-zhu;ZHANG Kun;YAN Jiu-xing(Tianjin Vocational College of Bioengineering,Tianjin 300462,China;Pharmacy College,Tianjin Medical University,Tianjin 300070,China)

机构地区：[1]天津生物工程职业技术学院,天津300462 [2]天津医科大学药学院,天津300070

出　　处：《中国药物评价》2024年第5期424-428,共5页Chinese Journal of Drug Evaluation

摘　　要：目的:挖掘并分析贝伐珠单抗超说明书用于新生血管性眼科疾病的药品不良事件(ADE)信号,指导临床合理用药。方法:基于FAERS数据库,收集2013~2023年间贝伐珠单抗眼部用药的ADE报告,应用比例失衡法挖掘ADE信号。结果:共收集ADE报告1612例,主要涉及新生血管性年龄相关性黄斑变性等,发现不良反应首选语(PT)3014个,显著风险集中于眼器官疾病与感染,且受玻璃体注射方式、制剂特性、给药形式及剂量影响。结论:贝伐珠单抗超说明书用于眼部疾病时,需密切关注其ADE。Objective:To identify and analyze adverse drug event(ADE)signals associated with the off-label use of bevacizumab in neovascular ophthalmic diseases,providing a basis for rational clinical drug use.Methods:ADE reports of bevacizumab for ocular conditions from 2013 to 2023 were collected from the FAERS database.The proportional imbalance method was applied to mine ADE signals.Results:A total of 1612 ADE reports were collected,primarily related to neovascular age-related macular degeneration(nAMD)among others.A total of 3,014 preferred terms(PT)of adverse reactions were identified,with significant risks concentrated in ocular organ diseases and infections.These ADEs were influenced by factors such as intravitreal injection technique,formulation characteristics,route of administration,and dosage.Conclusion:When bevacizumab is used off-label for ocular diseases,close attention must be paid to its adverse events.

关 键 词：贝伐珠单抗 眼部疾病 不良事件 超说明书用药 

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