在使用血管激素受体抑制剂的患者中,对新生瘤的回顾性分析
Arvind Kumar Sharma1,2, Shruti Rastogi3, Ramesh K Goyal1
1Delhi Pharmaceutical Sciences and Research University, Pushp vihar Sector 3, New Delhi, 110017, India.
Scientific reports
|July 9, 2024
概括
由于担心抗胰岛素受体阻断剂 (ARB) 中致癌性尼托胺,因此对安全报告进行了分析. 瓦尔萨坦与瘤风险有显著的关联,需要进一步调查ARB的安全性.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 心血管药理学心血管药理学
背景情况:
- 监管机构已经在血管激素受体阻断剂 (ARB) 配方中标记了潜在的致癌物质,如胺胺.
- 氨酸是已知的致癌物质,与瘤风险增加有关.
研究的目的:
- 使用自发安全数据调查ARB使用和瘤发展之间的潜在关联.
- 为了确定特定的ARBs,如果有的话,与瘤的风险增加有关.
主要方法:
- 分析来自EudraVigilance数据分析系统 (EVDAS) 的自发安全报告.
- 使用案例/非案例方法计算报告几率比率 (ROR) 和95%信心区间 (CI) 的不成比例分析.
主要成果:
- 总共分析了68,522份ARB安全报告,其中3,396 (5%) 的病例涉及瘤.
- 瓦尔萨坦在瘤中表现出最高的ROR (ROR 1.949,95% CI 1.857-2.046),即使与其他抗高血压药物相比,这种关联也很显著.
- 大多数报告来自德国和法国,医疗保健专业人员提交的报告约为70%.
结论:
- 这项研究表明,一种潜在的信号将ARB,特别是瓦尔沙坦与瘤风险增加联系在一起.
- 需要进一步的观察和分析研究来证实这些发现,并了解潜在的机制.
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