Wheeler Guy L, Braden Gregory A, Steinhubl Steven R, Kereiakes Dean J, Kottke-Marchant Kandice, Michelson Alan D, Furman Mark I, Mueller Michele N, Moliterno David J, Sane David C
Wake Forest University School of Medicine, Winston-Salem, NC 27157-1045, USA.
Am Heart J. 2002 Apr;143(4):602-11. doi: 10.1067/mhj.2002.121734.
Despite the proven benefit of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention, significant interpatient variability exists in antiplatelet response. Furthermore, a diminished degree of platelet inhibition is an independent predictor of adverse cardiac events, highlighting the need for accurate and precise monitoring of platelet function.
Patients (n = 192) who underwent elective percutaneous coronary intervention at 4 centers were enrolled. The following 3 time points were studied: 1, baseline, before abciximab bolus administration; 2, during, within 1 hour of abciximab bolus administration; and 3, post, 24 hours after abciximab bolus administration or at the time of patient discharge, whichever occurred first. The following 3 assays were compared at all time points: Ultegra rapid platelet-function assay (Ultegra RPFA), conventional turbidometric platelet aggregometry, and receptor binding assay with [125I]-abciximab. Variability in Ultegra RPFA measurements between operators was determined with performance of the assays at the point of care and in the laboratory. A sub-study of 22 patients at 1 center was performed in which the laboratory scientist performed all 3 assays in duplicate at each time point.
Comparison with the receptor binding assay and conventional platelet aggregometry in 120 patients showed that the Ultegra RPFA correlated with aggregometry (r = 0.89) and with the receptor binding assay (r = 0.89). There was good agreement (r = 0.80) between values obtained by intended users and those obtained by laboratory scientists. Furthermore, Ultegra RPFA values had equivalent precision to the standard assays.
The Ultegra RPFA has equivalent accuracy and precision when compared with the 2 reference assays studied. Ultegra RPFA measurements are not operator-dependent and are not influenced by concomitant medications, hematologic parameters, or demographics.
尽管糖蛋白IIb/IIIa抑制剂在经皮冠状动脉介入治疗期间已证实具有益处，但患者间的抗血小板反应存在显著差异。此外，血小板抑制程度降低是不良心脏事件的独立预测因素，这凸显了准确精确监测血小板功能的必要性。
纳入在4个中心接受择期经皮冠状动脉介入治疗的患者（n = 192）。研究了以下3个时间点：1. 基线，阿昔单抗推注给药前；2. 期间，阿昔单抗推注给药后1小时内；3. 术后，阿昔单抗推注给药后24小时或患者出院时（以先发生者为准）。在所有时间点比较了以下3种检测方法：Ultegra快速血小板功能检测（Ultegra RPFA）、传统比浊法血小板聚集检测和用[125I] - 阿昔单抗进行的受体结合检测。通过在即时护理点和实验室进行检测来确定操作人员之间Ultegra RPFA测量值的差异。在1个中心对22名患者进行了一项子研究，其中实验室科学家在每个时间点对所有3种检测方法进行了重复检测。
对120名患者进行的与受体结合检测和传统血小板聚集检测的比较显示，Ultegra RPFA与聚集检测（r = 0.89）以及与受体结合检测（r = 0.89）相关。预期使用者获得的值与实验室科学家获得的值之间具有良好的一致性（r = 0.80）。此外，Ultegra RPFA值与标准检测方法具有同等的精密度。
与所研究的2种参考检测方法相比，Ultegra RPFA具有同等的准确性和精密度。Ultegra RPFA测量值不依赖操作人员，且不受伴随用药、血液学参数或人口统计学因素的影响。
