与多发性骨髓瘤向治疗相关的心血管不良事件:一个药监测研究
Yanli Zhang1, Chang Shan1, Xinxin Zhang1
1Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
多发性骨髓瘤疗法携带心血管风险,例如达拉图穆马布 (daratumumab) 等特定药物显示出更高的不良事件率. 由于药物特定的风险和发病时间各不相同,监测至关重要.
科学领域:
- 血液学和瘤学研究
- 心血管医学 心血管医学
- 药物监督 药物监督 药物监督
背景情况:
- 多发性骨髓瘤 (MM) 是癌症死亡的一个重要原因.
- 最近的FDA批准已经扩大了针对MM的治疗方法.
- 这些疗法缺乏全面的心血管安全数据.
研究的目的:
- 调查MM向疗法与心血管不良事件 (AE) 之间的关联.
- 确定特定的心血管AE概况和药物特定风险.
主要方法:
- 对FDAAE报告系统数据 (2014-2023) 的不成比例分析.
- 使用标准化医学词典对监管活动查询 (SMQs) 进行心血管AE的分类.
- 在不同的MM向药物中对AE风险概况的比较.
主要成果:
- 确定了与MM向治疗相关的3228例心血管AE病例.
- 达拉图穆马布,埃洛图祖马布和伊萨图キシ马布在心血管AE方面表现出显著的不成比例.
- 心肌病,心律失常和栓塞/血栓事件是最常见的;非传染性心肌炎/心周炎显示出强烈的信号.
- 心血管AE风险在第一个月达到顶峰,然后下降,然后在一年后再次上升.
- 伊萨图西马布和埃洛图祖马布的心血管AE概率低于达拉图穆马布 (p < 0.001).
结论:
- 针对MM的向疗法与不同的心血管AE配置文件有关.
- 心血管风险因药物和发病时间而异,需要量身定制的监测.
- 针对MM向治疗的患者需要特定的管理策略.
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