稀释血红素时间,ecarin染色分析和UPLC-MS之间对血水平达比加特兰量化的比较:来自DRIVING研究的结果
Ambre de Fautereau-Vassel1, Antoine Mokhtarian1, Manon Mangenot1
1UR 7537 BioSTM (Biostatistics), Faculté de Pharmacie de Paris, Université Paris Cité, Paris, France.
International journal of laboratory hematology
|September 14, 2023
概括
稀释血时间 (dTT) 和基于ecarin的染色体测定 (ECA-II) 准确测量达比加特兰水平,这对于临床决策非常有用. 这些测定对达比加特兰代谢物进行了计算,确保在紧急情况下获得可靠的结果.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床化学 临床化学
- 分析化学 分析化学
背景情况:
- 准确的达比加特兰量化对于临床决策至关重要,特别是在紧急情况下,如手术或控制出血.
- 对于达比加特兰量化方法的比较数据有限,强调需要验证.
- 了解临床相关值 (30-50 ng/mL) 周围的测定性能至关重要.
研究的目的:
- 用三个不同的量化试验来比较达比加的血水平.
- 在临界度值时,评估常规测试与参考方法 (UPLC-MS) 之间的一致性.
- 评估dTT和ECA-II在紧急情况下的临床实用性.
主要方法:
- 60名健康的志愿者接受了一次300毫克的达比加乙酸盐剂量.
- 在24小时内收集了连续的血液样本.
- 血样本使用超高性能液态染色学-并联质谱学 (UPLC-MS),稀释血时间 (dTT) 和基于ecarin的染色学测定 (ECA-II) 来分析.
主要成果:
- 在dTT,ECA-II和UPLC-MS结果 (Deming回归) 之间观察到高相关性.
- 与UPLC-MS相比,dTT和ECA-II在>50 ng/mL水平上显示了一致的积极偏差 (+14%和+16%),表明了代谢物贡献.
- 在不同度范围 (<30,30-50,≥50 ng/mL) 中,dTT和ECA-II之间发现了很高的一致性 (90.6%,Cohen的卡帕为0.84).
结论:
- 稀释血时间 (dTT) 和基于ecarin的染色体测定 (ECA-II) 提供适合临床实践的快速和准确的达比加特兰水平测量.
- 无论是dTT还是ECA-II都适合应急使用.
- 这些测试有效地解释了达比加特兰代谢产品的血栓抑制作用.
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