摘要
目的了解Rybrevant(amivantamab-vmjw)不良反应特征,对于优化患者管理和提升治疗安全性具有重要意义。方法本研究利用美国FDA不良事件报告系统(FAERS)数据库,收集2021年至2023年期间与Rybrevant相关的不良反应报告。采用多种比例失衡分析方法,包括报告比值比(ROR)、比例报告率、贝叶斯置信传播神经网络及经验贝叶斯几何均值,识别并评估潜在安全性信号。结果共纳入415份不良事件报告,涉及871个首选术语。最主要的不良反应包括痤疮样皮炎(ROR:61.29)、肺炎(ROR:34.29)及输注相关反应(ROR:128.89)。同时亦有严重结局的报告,其中住院发生率为21.83%,死亡率为13.97%。本研究还识别出若干新型不良反应,包括肛门溃疡(ROR:307.86)、血清白蛋白降低(ROR:40.13)及低白蛋白血症(ROR:29.77)。讨论Rybrevant具有独特的不良反应特征,主要集中在皮肤毒性和呼吸系统毒性方面。持续的药物警戒和前瞻性管理措施对于平衡治疗风险、保障患者安全至关重要。
Objective To understand Rybrevant(amivantamab-vmjw)adverse drug reaction(ADR)profile is crucial for optimizing patient care and safety.Methods ADRs concerning Rybrevant were extracted from the FDA Adverse Event Reporting System(FAERS)database(2021—2023).We used disproportionality methods including reporting odds ratio(ROR),proportional reporting ratio,Bayesian Confidence Propagation Neural Network,or Empirical Bayesian Geometric Mean to identify and evaluate safety signals.Results A total of 415 adverse-event reports and 871 Preferred Terms were identified.The most significant ADRs included dermatitis acneiform(ROR:61.29),pneumonitis(ROR:34.29),and infusion-related reactions(ROR:128.89).Severe outcomes,such as hospitalization(21.83%)and death(13.97%),were also reported.Notably,novel adverse reactions,including anal ulcer(ROR:307.86),decreased blood albumin(ROR:40.13)and hypoalbuminaemia(ROR:29.77),were identified,warranting further investigation.Conclusion Rybrevant is associated with a distinct ADR profile,particularly related to skin and respiratory toxicity.Ongoing pharmacovigilance and proactive management are essential to balancing risks and ensuring patient safety.
作者
赵杰
张艳平
姜旭
康利波
李可欢
杨小玉
赵悦辰
马新利
ZHAO Jie;ZHANG Yanping;JIANG Xu;KANG Libo;LI Kehuan;YANG Xiaoyu;ZHAO Yuechen;MA Xinli(Department of Critical Care Medicine,The Second Hospital of Jilin University,Changchun 130022,China;Department of Orthopedics,The Second Hospital of Jilin University,Changchun 130022,China;Department of Radiation Oncology,The Second Hospital of Jilin University,Changchun 130022,China)
出处
《中国实验诊断学》
2025年第9期1096-1101,共6页
Chinese Journal of Laboratory Diagnosis
