Boekhout-Mussert M J, van der Kolk-Schaap P J, Hermans J, Loeliger E A
Am J Clin Pathol. 1981 Mar;75(3):297-303. doi: 10.1093/ajcp/75.3.297.
A prospective double-blind trial was performed to investigate the safety of long-term oral anticoagulant control when dosaged adjustment depends on the prothrombin times assessed with one type of thromboplastin being calculated as if assayed by another type. The three main types of thromboplastin, i.e., bovine (Thrombotest), human (British Comparative Thromboplastin), and rabbit (Simplastin Automated) were tested. Before entering the actual trial, patients had been checked with the bovine type of thromboplastin. During the actual comparison study, prothrombin times obtained with the human and the rabbit types of thromboplastin were translated, using the appropriate calibration data, into terms of the bovine type of thromboplastin, which were used for dosage prescription. After six months, all patients returned to bovine-type thromboplastin control. No substantial difference among the three groups was observed in the prothrombin times, the dosage of the anticoagulant, the bleeding complications, and the dropouts. It was concluded that the safety of monitoring patients receiving long-term oral anticoagulation was independent of the type of thromboplastin used.
进行了一项前瞻性双盲试验，以研究当剂量调整取决于用一种凝血活酶评估的凝血酶原时间（却按另一种凝血活酶的测定方式进行计算）时长期口服抗凝控制的安全性。测试了三种主要类型的凝血活酶，即牛源性（血栓试验）、人源性（英国比较凝血活酶）和兔源性（简易凝血活酶自动分析仪）。在进入实际试验之前，患者已用牛源性凝血活酶进行了检查。在实际比较研究期间，使用适当的校准数据，将用人源性和兔源性凝血活酶获得的凝血酶原时间换算为牛源性凝血活酶的数值，用于剂量处方。六个月后，所有患者恢复为牛源性凝血活酶控制。在凝血酶原时间、抗凝剂剂量、出血并发症和退出试验的情况方面，三组之间未观察到实质性差异。得出的结论是，监测接受长期口服抗凝治疗患者的安全性与所使用的凝血活酶类型无关。
