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首页> 外文期刊>Clinical and applied thrombosis/hemostasis : >An Evaluation of a Factor Xa-Based Clotting Time Test for Enoxaparin: A Proof-of-Concept Study
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An Evaluation of a Factor Xa-Based Clotting Time Test for Enoxaparin: A Proof-of-Concept Study

机译：依诺肝素基于因子Xa的凝血时间测试的评估：概念验证研究。

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摘要

A well-accepted test for monitoring anticoagulation by enoxaparin is not currently available. As inadequate dosing may result in thrombosis or bleeding, a clinical need exists for a suitable test. Previous in silico and in vitro studies have identified factor Xa as an appropriate activating agent, and the phospholipid Actin FS as a cofactor for a Xa clotting time (TenaCT) test. A proof-of-concept study was designed to (1) explore the reproducibility of the TenaCT test and (2) explore factors that could affect the performance of the test. In vitro clotting time tests were carried out using plasma from 20 healthy volunteers. The effect of enoxaparin was determined at concentrations of 0.25, 0.50, and 1.0 IU/mL. Clotting times for the volunteers were significantly prolonged with increasing enoxaparin concentrations. Clotting times were significantly shortened for frozen plasma samples. No significant differences in prolongation of clotting times were observed between male and female volunteers or between the 2 evaluated age groups. The clotting times were consistent between 2 separate occasions. The TenaCT test was able to distinguish between the subtherapeutic and therapeutic concentrations of enoxaparin. Plasma should not be frozen prior to performing the test, without defining a frozen plasma reference range. This study provided proof-of-concept for a Xa-based test that can detect enoxaparin dose effects, but additional studies are needed to further develop the test.
机译：目前尚无法获得用于监测依诺肝素抗凝作用的公认试验。由于剂量不足可能导致血栓形成或出血，因此临床上需要进行合适的测试。先前的计算机模拟和体外研究已将因子Xa鉴定为合适的活化剂，并且将磷脂肌动蛋白FS鉴定为Xa凝固时间（TenaCT）测试的辅助因子。概念验证研究旨在（1）探索TenaCT测试的可重复性，以及（2）探索可能影响测试性能的因素。使用来自20名健康志愿者的血浆进行了体外凝血时间测试。在0.25、0.50和1.0 IU / mL的浓度下测定依诺肝素的作用。随着依诺肝素浓度的增加，志愿者的凝血时间显着延长。冷冻血浆样品的凝结时间明显缩短。在男性和女性志愿者之间或在两个评估的年龄组之间，未观察到凝血时间延长的显着差异。在两个不同的情况下，凝血时间是一致的。 TenaCT测试能够区分依诺肝素的亚治疗浓度和治疗浓度。在未定义冻结血浆参考范围的情况下，不应在执行测试之前冻结血浆。这项研究为基于Xa的测试提供了概念验证，该测试可以检测依诺肝素的剂量效应，但是还需要进一步的研究以进一步开发该测试。

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