CoaguChek XS在抗磷脂综合征患者中的准确性

James R. Taylor, C. Richter, Chris Lindamood, Xinyu Liu, M. Zumberg, Brad Fletcher
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引用次数: 5

摘要

CoaguChek XS仪表是一种国际标准化比率(INR)护理点(POC)监测仪,已被证明提供临床可接受的准确性。由于抗磷脂抗体与用于凝血酶原时间INR测定的试剂之间存在潜在的相互作用,因此在抗磷脂综合征(apl)患者中使用POC INR监测器的可靠性存在不确定性。研究人群包括41例接受华法林治疗的apl患者(治疗组)或任何其他适应症(对照组)。所有患者的INR均由CoaguChek XS仪器和中心实验室进行分析。总体而言,CoaguChek XS与实验室在apl患者中的平均INR差异为0.6772 (P < 0.0001)。在apl患者中,当实验室INR小于2.0、2.0 ~ 3.0、3.1 ~ 4.0、大于4.0时,CoaguChek XS的平均差异分别为0.0636 (P = 0.4111)、0.6903 (P < 0.0001)、1.1417 (P < 0.0001)、0.9333 (P = 0.0848)。对照组总平均差异为0.5456 (P < 0.0001)。实验室INR值小于2.0、2.0 ~ 3.0、3.1 ~ 4.0和大于4.0时,与CoaguChek XS的平均差异分别为0.3000 (P = 0.0003)、0.4444 (P < 0.0001)、1.0444 (P = 0.0002)和1.3500 (P = 0.0236)。我们的数据确实支持制造商在apl患者中比较实验室和CoaguChek XS仪表INRs的建议,因为在一部分患者中,这两种方法产生了可接受的结果,并且可以使用POC监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Accuracy of CoaguChek XS in Patients With Antiphospholipid Syndrome
Abstract The CoaguChek XS meter is an international normalized ratio (INR) point-of-care (POC) monitor that has been shown to provide clinically acceptable accuracy. Because of a potential interaction between antiphospholipid antibodies and the reagent used in the prothrombin time INR assay, there is uncertainty as to the reliability of using POC INR monitors in patients with antiphospholipid syndrome (APLS). The study population consisted of 41 patients on warfarin therapy for either APLS (treatment group) or any other indication (control group). All patients had their INR analyzed by the CoaguChek XS meter and a central laboratory. Overall, the mean INR difference between the CoaguChek XS and laboratory in the APLS patients was 0.6772 (P < 0.0001). In APLS patients, when the laboratory INR was less than 2.0, 2.0 to 3.0, 3.1 to 4.0, or greater than 4.0, the CoaguChek XS differed by averages of 0.0636 (P = 0.4111), 0.6903 (P < 0.0001), 1.1417 (P < 0.0001), and 0.9333 (P = 0.0848), respectively. In the control group the overall mean difference was 0.5456 (P < 0.0001). For laboratory INR values of less than 2.0, 2.0 to 3.0, 3.1 to 4.0, and greater than 4.0, the mean differences from the CoaguChek XS were 0.3000 (P = 0.0003), 0.4444 (P < 0.0001), 1.0444 (P = 0.0002), and 1.3500 (P = 0.0236). Our data do support the manufacturer recommendation of comparing laboratory and CoaguChek XS meter INRs in APLS patients because in a subset of patients the 2 methods produced acceptable results, and POC monitoring might be used.
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