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通过药监测研究发现预后生物标志物:RDW的案例

Valerio Liguori^1,2, Antonietta Anatriello^1,2, Alessia Zinzi^1,3

¹Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.

Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico

|June 15, 2025

概括

红细胞分布宽度 (RDW) 可以作为瘤学中的预后生物标志物,特别是在接受免疫检查点抑制剂 (ICI) 治疗的患者中. 需要进一步的研究来证实其在监测治疗结果中的有用性.

科学领域:

在瘤学瘤学.
药物监督药物监督药物监督
临床生物标志物临床生物标志物

背景情况:

红细胞分布宽度 (RDW) 正在成为瘤学中的预后生物标志物,与全身炎症和癌症进展有关.
现有研究表明,RDW变化与预后不佳之间存在相关性,但其在接受免疫检查点抑制剂 (ICI) 治疗的患者中的作用尚未明确.

研究的目的:

研究红细胞分布宽度 (RDW) 变化与接受PD-1抑制剂治疗的患者的治疗结果之间的关系.
利用Eudra Vigilance (EV) 的药监数据来分析RDW作为该患者群体的预后指标的潜力.

主要方法:

从Eudra Vigilance数据库中获取博利祖马布和尼沃卢马布的个体病例安全报告 (ICSR) (2015年1月至2025年3月).
计算了95%置信区间 (CI) 的报告几率比率 (ROR),以评估对感兴趣药物的"调查"系统器官类内报告不良事件的概率.

主要成果:

分析了12289个ICSR:布罗利祖马布6981 (56.8%) 和尼沃卢马布5308 (43.2%) ,主要是18-64岁的男性.
与尼沃卢马布相比,布利祖马布的血小板数量下降 (ROR 2.41,95% CI 2.14-2.72),中性粒细胞数量下降 (ROR 1.55,95% CI 1.34-1.80),白细胞数量下降 (ROR 1.50,95% CI 1.26-1.78),血氨酸增加 (ROR 1.19,95% CI 1.01-1.42) 和C反应蛋白增加 (ROR 1.28,95% CI 1.07-1.53) 的报告概率更高.

结论:

这项研究为接受免疫检查点抑制剂 (ICI) 治疗的患者的红细胞分布宽度 (RDW) 的潜在预后价值提供了新的见解.
这些发现强调需要进一步调查,以确定RDW在监测ICI治疗疗效和患者结果中的实用性.

关键词:

血液学参数血液学参数免疫检查点抑制剂免疫检查点抑制剂尼沃卢马布的使用情况佩姆布罗利兹马布的使用方法红细胞分布宽度红细胞分布宽度安全的安全的安全的安全的安全.

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