| 引用本文: | 阮聪,徐蕊.基于FAERS对维泊妥珠单抗不良事件信号的挖掘与分析[J].中国现代应用药学,2025,42(2):63-68. |
| RuanCong,Rui Xu.Mining and Analysis of Adverse Event Signals of Polatuzumab Based on FAERS[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(2):63-68. |
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| 摘要: |
| 目的 靶向CD79b的抗体偶联药物维泊妥珠单抗进行药品不良事件信号挖掘分析，为临床安全用药提供参考。方法 从美国食品药品监督管理局不良事件报告系统中提取2019年1月1日至2023年6月30日的药物不良事件报告，合并去除重复报告，并对不良事件信号采用比例失衡法筛选分析。结果 获得以维泊妥珠单抗为首要怀疑药物的不良事件报告共1037例，筛选后得到说明书中未记载的不良事件信号23个，包括免疫效应细胞相关神经毒性综合征、细胞因子释放综合征和弥漫性血管内凝血等。 结论 挖掘的真实世界ADE 报告与说明书中相近，同时报告了新的不良事件，为维泊妥珠单抗临床安全应用监测提供参考。 |
| 关键词: 维泊妥珠单抗 数据挖掘 不良事件 免疫效应细胞相关神经毒性综合征 细胞因子释放综合征 弥漫性血管内凝血 |
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| 基金项目:上海市闵行区卫健委课题(2021MW28)；闵行区卫生健康系统优秀青年药学人才培养计划(mwyjyx03)；闵行区健康科普能力提升英才专项（MHJKKPYC-2023-10） |
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| Mining and Analysis of Adverse Event Signals of Polatuzumab Based on FAERS |
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RuanCong, Rui Xu
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Minhang Branch of Fudan University Cancer Hospital
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| Abstract: |
| OBJECTIVE To analyze the adverse drug events (ADE) signal mining of CD79b-targeted antibody conjugate drug Polatuzumab, and to provide reference for clinical safe drug use. METHODS Drug ADE reports from January 1, 2019 to June 30, 2023 were extracted from the US Food and Drug Administration Adverse Event Reporting System (FAERS). Duplicate reports were pooled and eliminated, and ADE signals were screened and analyzed by the proportional imbalance method. RESULTS A total of 1037 adverse events were reported with Polatuzumab, including 23 adverse events not recorded in the instructions, including intestinal obstruction, oral candidiasis, diffuse intravascular coagulation and cytokine release syndrome. CONCLUSION The excavated real-world ADE report are similar to the instructions, reporting new adverse events and providing reference for clinical monitoring of safe application of Polatuzumab. |
| Key words: Polatuzumab Data mining Adverse event Immune effector cell-associated neurotoxicity syndrome Cytokine release syndrome Disseminated intravascular coagulation |
