接受维生素 K 拮抗剂固定剂量治疗的患者的即时检测和 INR 个体内变异。
Point-of-care testing and INR within-subject variation in patients receiving a constant dose of vitamin K antagonist.
机构信息
A. M. H. P. van den Besselaar, Department of Thrombosis and Hemostasis, Leiden University Medical Center, P. O. Box 9600, 2300 RC Leiden, The Netherlands, Tel.: +31 71 5261894, Fax: +31 71 5266868, E-mail: a. m. h.
出版信息
Thromb Haemost. 2015 Nov 25;114(6):1260-7. doi: 10.1160/TH15-02-0128. Epub 2015 Jul 23.
Many patients treated with vitamin K antagonists (VKA) determine their INR using point-of-care (POC) whole blood coagulation monitors. The primary aim of the present study was to assess the INR within-subject variation in self-testing patients receiving a constant dose of VKA. The second aim of the study was to derive INR imprecision goals for whole blood coagulation monitors. Analytical performance goals for INR measurement can be derived from the average biological within-subject variation. Fifty-six Thrombosis Centres in the Netherlands were invited to select self-testing patients who were receiving a constant dose of either acenocoumarol or phenprocoumon for at least six consecutive INR measurements. In each patient, the coefficient of variation (CV) of INRs was calculated. One Thrombosis Centre selected regular patients being monitored with a POC device by professional staff. Sixteen Dutch Thrombosis Centres provided results for 322 selected patients, all using the CoaguChek XS. The median within-subject CV in patients receiving acenocoumarol (10.2 %) was significantly higher than the median CV in patients receiving phenprocoumon (8.6 %) (p = 0.001). The median CV in low-target intensity acenocoumarol self-testing patients (10.4 %) was similar to the median CV in regular patients monitored by professional staff (10.2 %). Desirable INR analytical imprecision goals for POC monitoring with CoaguChek XS in patients receiving either low-target intensity acenocoumarol or phenprocoumon were 5.1 % and 4.3 %, respectively. The approximate average value for the imprecision of the CoaguChek XS, i. e. 4 %, is in agreement with these goals.
许多接受维生素 K 拮抗剂 (VKA) 治疗的患者使用即时检测 (POC) 全血凝血监测仪来确定其 INR。本研究的主要目的是评估接受固定 VKA 剂量的自我检测患者的 INR 个体内变异。研究的第二个目的是为全血凝血监测仪推导 INR 不精密度目标。INR 测量的分析性能目标可以从平均生物学个体内变异推导得出。荷兰的 56 个血栓中心被邀请选择至少连续 6 次 INR 测量接受固定剂量 acenocoumarol 或 phenprocoumon 的自我检测患者。在每个患者中，计算 INR 的变异系数 (CV)。一个血栓中心选择由专业人员使用 POC 设备监测的常规患者。16 个荷兰血栓中心为 322 名选定患者提供了结果，所有患者均使用 CoaguChek XS。接受 acenocoumarol 的患者的个体内 CV 的中位数（10.2%）显著高于接受 phenprocoumon 的患者的 CV 的中位数（8.6%）（p = 0.001）。低目标强度 acenocoumarol 自我检测患者的 CV 中位数（10.4%）与由专业人员监测的常规患者的 CV 中位数（10.2%）相似。对于接受低目标强度 acenocoumarol 或 phenprocoumon 的患者，使用 CoaguChek XS 进行 POC 监测的理想 INR 分析不精密度目标分别为 5.1%和 4.3%。CoaguChek XS 的不精密度近似平均值，即 4%，与这些目标一致。
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