与静脉注射铁制品相关的过敏反应的比较风险
Cunlin Wang1, David J Graham1, Robert C Kane2
1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA
|November 18, 2015
概括
静脉注射铁的过敏反应风险明显高于其他静脉注射铁制品. 在所有测试的静脉铁配方中,铁糖具有最低的过敏反应风险.
科学领域:
- 药物监督管理
- 临床药理学
- 医疗服务研究
背景情况:
- 静脉注射 (IV) 铁制品与过敏反应有关,但对比安全性数据有限.
- 了解不同静脉铁配方的过敏反应风险对患者安全至关重要.
研究的目的:
- 为了比较市场上各种静脉注射铁产品的过敏反应风险.
- 确定哪些静脉铁配方具有最高和最低的过敏反应风险.
主要方法:
- 从2003年至2013年对688,183名美国医疗保险受益人的回顾性队列研究.
- 通过对索赔数据进行验证的算法,对IV铁,葡萄糖酸盐,糖糖和铁醇进行了过敏反应风险评估.
- 调整的概率比率是为了比较不同静脉铁制品之间的过敏反应风险.
主要成果:
- 与所有其他静脉注射铁制品 (24/ 100,000) 相比,铁德克斯坦在第一次接触时的过敏反应风险显著更高.
- 与铁糖相比,铁的过敏反应发生率增加了3. 6倍,铁酸盐增加了2. 0倍,铁酸盐增加了2. 2倍.
- 在1000毫克的铁补充后,对铁的累积风险最高 (82/ 100,000),对铁糖的累积风险最低 (21/ 100,000).
结论:
- 在美国Medicare非透析患者中,IV铁制品中,铁与过敏反应的风险最高.
- 对于过敏反应的风险,铁糖似乎是最安全的静脉铁制剂.
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