蛋白酶体抑制剂相关的血栓性微血管病变:现实世界的回顾性和药监数据库分析
Zhenzhen Deng1, Shengfeng Wang1, Chunjiang Wang2
1Department of Pharmacy, The Third Xiangya Hospital, Central South University, Tongzipo Street, Yuelu District, Changsha, 410013, Hunan, China.
概括
蛋白酶体抑制剂 (PI) 与血栓性微血管病变 (TMA) 有关. 卡菲尔佐米布显示了最高的关联,迅速诊断和支持性护理对于患有TMA症状的PI患者至关重要.
科学领域:
- 血液学 血液学 血液学
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
背景情况:
- 血栓性微血管病变 (TMA) 是卡菲尔佐米布治疗的已知并发症.
- 其他蛋白酶体抑制剂 (PI) (如博尔特佐米布或伊克萨佐米布) 与TMA之间的关联尚不清楚.
- 现有的关于卡菲尔佐米布诱导的TMA知识主要依赖于病例报告.
研究的目的:
- 量化与蛋白酶体抑制剂 (PI) 使用相关的TMA风险.
- 描述PI诱导的TMA的临床特征.
- 评估PI诱导的TMA的支持性治疗的安全性和有效性.
主要方法:
- 来自FDA不良事件报告系统 (FAERS) 数据库 (2004-2023) 的TMA事件的不成比例分析.
- 对PI诱导的TMA (2004-2023) 的病例报告和系列的回顾性分析.
主要成果:
- 蛋白质酶抑制剂 (PI) 与TMA显著相关 (ROR 1.71).
- 卡菲尔佐米布显示出TMA的最高比例 (58.7%) 和最强的信号 (ROR 17.97).
- 典型的症状包括血液溶解性贫血,血小板缺血和急性损伤,平均发病时间为8天. 支持性治疗,如血交换和eculizumab,显示出改善的结果.
结论:
- 蛋白酶体抑制剂 (PI) 与血栓性微血管病变 (TMA) 的风险增加有关.
- 卡菲尔佐米布在PI中具有最高的风险.
- 早期诊断和及时的支持性治疗,包括血交换和eculizumab,对于患有TMA症状的PI患者至关重要.
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