与抗癌和免疫系统向药物相关的血栓性微血管病变:使用世卫组织药监数据库的现实数据的新见解
Bérenger Largeau1, Benjamin Thoreau2, Steven Grangé3,4
1Service de Pharmacosurveillance, Centre Régional de Pharmacovigilance, Hôpital Bretonneau, CHU Tours, Tours, France.
Journal of internal medicine
|August 4, 2023
概括
免疫瘤学药物越来越多地与血栓性微血管病症综合征 (TMA) 相关. 这项研究分析了全球安全报告,确定了新的药物风险和与这些先进的癌症疗法相关的TMA病例的不断变化的模式.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 血液学 血液学 血液学
背景情况:
- 免疫瘤学和抗癌药物至关重要,但可能导致血栓性微血管病症综合征 (TMA).
- 现实世界的数据对于理解与药物相关的TMA风险至关重要.
- 该研究的重点是确定与TMA相关的特定药物,并跟踪报告趋势.
研究的目的:
- 为了确定与TMA报告相关的免疫系统向/抗癌药物.
- 分析有关这些药物的TMA报告的时间演变.
- 在这些药物类别中检测TMA的潜在新安全问题.
主要方法:
- 来自VigiBase (1968-2022) 的个案安全报告 (ICSR) 的全球不成比例分析.
- 包括来自55个国家的6946个疑似药物诱导的TMA病例.
- 评估药物过度报告和TMA病例报告的趋势.
主要成果:
- 72种免疫系统向/抗癌药物显示TMA显著过度报告;17种是潜在的新安全问题.
- 虽然每百万ICSR的TMA报告率保持稳定,但绝对病例数量在过去十年增加.
- 涉及这些药物的TMA病例比例从47.3% (1992-2001) 增加到80.7% (2012-2021).
结论:
- 新的免疫系统向/抗癌药物越来越多地与TMA相关.
- 需要进行确认性研究来验证这些潜在的新药-TMA关联.
- 与药物相关的TMA的增加主要是由创新的抗癌疗法推动的.
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