中国临床药理学与治疗学2024，Vol.29Issue(7)：752-761,10.DOI:10.12092/j.issn.1009-2501.2024.07.004
基于FAERS数据库的维泊妥珠单抗不良反应信号挖掘
Signal mining and analysis of adverse drug reactions for polatuzumab vedotin based on FAERS database
摘要
Abstract
AIM:To evaluate and analyze the post-marketing adverse drug reaction(ADR)signals of polatuzumab vedotin,so as to provide reference for clinical safety management.METHODS:Using the FDA adverse drug event reporting system(FAERS)database and OpenVigil data platform,the ADR reports of polatuzumab vedotin were collect-ed from June 10,2019(FDA approval for market-ing)to the March 31,2023.The ADR signals were detected by using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)in the pro-portional imbalance method.To increase the threshold and obtain stronger and more frequently occurring ADRs,a second screening of signals was performed.RESULTS:A total of 2 408 ADR reports related to polatuzumab vedotin were collected,and 83 ADR signals were detected after secondary screening.26 ADR signals were not mentioned in the drug instructions such as abnormal spinal mag-netic resonance imaging,increased bone resorp-tion,osteolysis,decreased aspartate aminotransfer-ase,decreased alanine aminotransferase,hypofibri-nogenemia,and pulmonary embolism.The system organ classes with a high signal counts or cumula-tive number of cases included infections and inva-sive diseases(24 signals,632 cases),various exami-nations(17 signals,675 cases),blood and lymphat-ic system diseases(11 signals,734 cases),various nervous system diseases(7 signals,153 cases),im-mune system diseases(3 signals,95 cases),system-ic diseases and various reactions at the site of ad-ministration(2 signals,145 cases),and systemic dis-eases and various reactions at the site of adminis-tration(2 signals,87 cases),etc.CONCLUSION:In addition to the common ADRs suggested by the in-structions,this study identified new ADR risk sig-nals for polatuzumab vedotin.In the clinical appli-cation of polatuzumab vedotin,in addition to the ADR mentioned in the instructions such as infec-tions,myelosuppression,peripheral neuropathies,infusion-related reactions,and abnormal liver func-tion,attention should also be paid to the risk sig-nals not mentioned such as abnormal spinal mag-netic resonance imaging,and increased bone re-sorption.关键词
维泊妥珠单抗/弥漫大B细胞淋巴瘤/不良反应/美国食品药品监督管理局药物不良事件报告系统/信号挖掘Key words
polatuzumab vedotin/diffuse large B-cell lymphoma/adverse drug reaction/FDA adverse drug event reporting system/signal mining分类
医药卫生引用本文复制引用
宋再伟,李欣亚,门鹏,姜丹,董菲,赵荣生,杨珺..基于FAERS数据库的维泊妥珠单抗不良反应信号挖掘[J].中国临床药理学与治疗学,2024,29(7):752-761,10.基金项目
北京市卫生健康科技成果和适宜技术推广项目(BHTPP2022079) （BHTPP2022079）
