在全身暴露于血管内皮生长因子通路抑制剂期间,动脉剖析的风险
Jun Okui1,2, Takashi Waki1,2, Kazuhiro Kajiyama1,2,3
1Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Clinical and translational science
|December 2, 2024
概括
血管内皮生长因子通路抑制剂 (VPIs) 可能会增加动脉剖析风险. 现实世界的数据表明这是一个类效应,需要在VPI使用过程中给予临床关注.
科学领域:
- 在瘤学瘤学.
- 血管医学 血管医学
- 药物监督 药物监督 药物监督
背景情况:
- 血管内皮生长因子通路抑制剂 (VPI) 与动脉剖析风险之间的关联尚不清楚.
- 评估动脉剖析作为VPI的潜在类效应对于患者安全至关重要.
研究的目的:
- 量化评估动脉剖析风险作为VPI的类效应.
- 利用全国范围的真实世界数据进行全面分析.
主要方法:
- 一项使用日本国家健康保险索赔数据库 (NDB) 从2012年至2020年进行的队列研究.
- 包括12种类型的VPI处方的患者.
- 动脉剖析发病率 (IR) 对于每个VPI与贝瓦齐祖马布的比较,以年龄和性别进行调整.
主要成果:
- 贝瓦齐祖马布的动脉剖析发生率为每10万人/年为44.4.
- 与贝瓦西祖马布相比,其他VPI的调整后发病率比率始终在1.0或以上.
- VPIs显示的IR高于原始和标准化的自然发病率.
结论:
- 现实世界的证据表明,动脉剖析可能是VPI的类效应.
- 由于这种潜在风险,在处方VPI时需要提高临床警.
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