Martínez-Brotóns F, Borrell M, Fontcuberta J, Batlle J, López F, Páramo J A, Ribera C, Rocha E, Vicente V, Zuazu I
Ciudad Sanitaria de Bellvitge, Barcelona.
Sangre (Barc). 1994 Aug;39(4):245-51.
The purpose of the present study was to compare the results obtained with a human recombinant thromboplastin (Innovin, Baxter) (IN) and a high-sensitivity rabbit brain reagent (Thromboplastin IS, Baxter) (IS), on the performance of prothrombin time (PT) test and the functional assay of factors included in the extrinsic coagulation system, in order to establish possible differences on imprecision, diagnostic accuracy and sensitivity to the oral anticoagulant defect, between the two products.
Six Spanish hospital took part in the study. Plasma samples from 221 healthy subjects, 100 patients with severe liver disease, 27 with dysfibrinogenaemia, 10 with lupus anticoagulant and from 13 individuals propositus and their relatives with congenital deficiencies of the extrinsic coagulation pathway, and their relatives were studied; 188 patients stabilized on oral anticoagulant therapy and 82 on heparin therapy were also included. The in vitro effect of heparin was tested by addition of increasing amounts of heparin (0.3 to 10.0 IU/mL) to aliquots of normal plasma.
Both in the intra-assay and in the inter-assay imprecision study, a better coefficient of variation was obtained with IN when the PT was performed on abnormal samples. Prothrombin time ratio from patients with liver disease had significantly higher values with IS. On the contrary, IN had a higher sensitivity in samples from patients with dysfibrinogenaemia or from those stabilized on oral anticoagulant therapy. In showed a very low sensitivity to heparin at concentrations corresponding to the therapeutic range.
The results of this field study indicate that IN, compared with a high-sensitivity rabbit brain thromboplastin, is a suitable reagent for PT determination in normal subjects, patients with liver disease or with congenital deficiencies of clotting factors. It shows a higher sensitivity in cases of dysfibrinogenaemia and in patients on oral anticoagulant therapy. In addition, the recombinant reagent had better reproducibility when the PT was performed on abnormal samples, and it was hardly affected by heparin within the therapeutic range.
本研究旨在比较人重组凝血活酶（Innovin，百特公司）（IN）和高灵敏度兔脑试剂（凝血活酶IS，百特公司）（IS）在凝血酶原时间（PT）检测以及外源性凝血系统相关因子功能测定中的结果，以确定这两种产品在不精密度、诊断准确性以及对口服抗凝剂缺陷的敏感性方面是否存在差异。
六家西班牙医院参与了本研究。对221名健康受试者、100名严重肝病患者、27名异常纤维蛋白原血症患者、10名狼疮抗凝物患者以及13名外源性凝血途径先天性缺陷患者及其亲属的血浆样本进行了研究；还纳入了188名接受口服抗凝治疗且病情稳定的患者以及82名接受肝素治疗的患者。通过向正常血浆等分试样中添加递增剂量的肝素（0.3至10.0 IU/mL）来检测肝素的体外效应。
在批内和批间不精密度研究中，对异常样本进行PT检测时，IN的变异系数更佳。肝病患者的凝血酶原时间比值使用IS时显著更高。相反，IN对异常纤维蛋白原血症患者或接受口服抗凝治疗且病情稳定患者的样本具有更高的敏感性。在对应治疗范围的浓度下，IN对肝素的敏感性非常低。
本现场研究结果表明IN与高灵敏度兔脑凝血活酶相比，是用于正常受试者、肝病患者或凝血因子先天性缺陷患者PT测定的合适试剂。在异常纤维蛋白原血症病例和接受口服抗凝治疗的患者中，它表现出更高的敏感性。此外，如果对异常样本进行PT检测，重组试剂具有更好的重复性，并且在治疗范围内几乎不受肝素影响。
