贝伐珠单抗不良事件信号挖掘和用药风险分析  

Signal Mining and Risk Analysis of Adverse Events of Bevacizumab

作　　者：孙小东[1] 王静 陈力[3] SUN Xiaodong;WANG Jing;CHEN Li(Department of Pharmacy,Dazhou Central Hospital,Dazhou 635000,China;Department of Pharmacy,Sichuan Mianyang 404 Hospital,Mianyang 621000,China;Department of Pharmacy/Evidence-based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610066,China)

机构地区：[1]达州市中心医院药学部,达州635000 [2]四川绵阳四0四医院/绵阳市第一人民医院药学部,绵阳621000 [3]四川大学华西第二医院药学部/循证药学中心,成都610066

出　　处：《医药导报》2024年第5期814-820,共7页Herald of Medicine

摘　　要：目的挖掘贝伐珠单抗的不良事件(AE)信号,总结相关AE临床特征和用药风险,为临床安全用药提供参考。方法提取美国食品药品管理局(FDA)不良事件报告系统(FAERS)中2019年第1季度至2023年第1季度贝伐珠单抗的相关AE报告,应用比例失衡法中的报告比值比(ROR)法和综合标准(MHRA)法对进行数据挖掘及分析。结果共收集贝伐珠单抗AE报告17831份,相应有效信号映射得到的系统器官(SOC)共24个,其中各类损伤、中毒及操作并发症占比最大(18.82%),其次为血液及淋巴系统疾病(12.14%)和各类检查(12.07%);较为常见的AE为超说明书使用(3478例)、故意导致的产品使用问题(1040例)、高血压(993例)等。关联度较大的AE主要有视网膜血管造影异常(ROR 2916.79)、软骨坏死(ROR 911.34)、喉坏死(ROR 607.73)等,且其中80%为贝伐珠单抗新的药品不良反应(ADR)。结论使用贝伐珠单抗除了关注常见的ADR外,还需关注是否可能产生新的ADR。该药超说明书使用情况较多,临床药师应严格把关其使用的规范性、合理性、安全性。Objective To investigate the adverse event(AE)signal caused by bevacizumab,to summarize the clinical characteristics and medication risks of related AE,and to provide an evidence for safe clinical medication.Methods The AE reports related to bevacizumab from the U.S.FDA Adverse Event Reporting System(FAERS)from the first quarter of 2019 to the first quarter of 2023 were extracted,and the reported odds ratio method(ROR method)and comprehensive standard method(MHRA method)were used for data mining and analysis.Results A total of 17831 AE reports of bevacizumab were collected,and 24 systematic organ classifications(SOC)were obtained by corresponding effective signal mapping,among which various injuries,poisoning,and operational complications accounted for the largest proportion(18.82%),followed by diseases of the blood and lymphatic system(12.14%)and various examinations(12.07%).The more common AEs were off-label use(3478 cases),intentionally caused product use problems(1040 cases),hypertension(993 cases).AEs with high correlation were mainly abnormal retinal angiography(ROR 2916.79),cartilage necrosis(ROR 911.34),larynx necrosis(ROR 607.73),and 80%of them were new adverse drug reactions(ADRs)of bevacizumab.Conclusions In the use of bevacizumab,attention should be paid to the common ADRs and the possible occurrence of new ADRs.There are many cases of off-label use of this drug,clinical pharmacists should strictly check the normalization,rationality,and safety of its use.

关 键 词：贝伐珠单抗 超说明书用药 安全用药 

分 类 号：R979.1[医药卫生—药品] R969.3[医药卫生—药学]