Sakayori Tasuku, Naito Sumiyoshi, Yoshida Mika, Kumano Osamu, Kato Noriyoshi, Okuda Masahiro, Ieko Masahiro
Department of Internal Medicine, Health Sciences University of Hokkaido, Ishikari-gun, Hokkaido 061-0293, Japan.
Rinsho Byori. 2010 Aug;58(8):779-85.
Prothrombin time (PT) is widely used as the monitor of oral anticoagulant therapy using ISI/NR system which WHO recommended. However, a main clinical usefulness of an Owren-type combined reagent (TT) also remains in the monitoring of warfarin in Europe and Japan. Recently, a TT reagent utilizing a recombinant bovine tissue factor (TF) expressed by silkworm-baculovirus system has been developed. The purpose of this study is to investigate the sensitivity to coagulation factors (FII, FV, FVII, FX) of PT (rabbit brain and recombinant human) and TT (bovine brain and recombinant bovine) in INR, and the correlation among those reagents using 53 plasma samples from patients treated with warfarin. The INR results were calculated using a certified INR calibrator, "AK-CALIBRANT", according to the method of "Direct" INR determination. The sensitivity to FII, FVII and FX of those reagents results similar behavior in INR, but the sensitivity to FV of PT reagents were generally higher than that of TT reagents. The correlation coefficient between recombinant PT and recombinant TT was 0.979. There were a good agreement between two TT reagents (bovine brain and recombinant bovine) in INR (r = 0.998). It was apparent that a variance between PT and TT was dependent on the sensitivity to FV level during the course of warfarin treatment in a clinical case. In conclusion, PT and TT reagents gave generally acceptable correlation in INR, and our results indicate that the Owren-type TT reagent is also well suited for monitoring warfarin using local INR calibration according to WHO recommendation.
凝血酶原时间（PT）被广泛用作采用世界卫生组织推荐的国际敏感度指数（ISI）/比值（NR）系统的口服抗凝治疗的监测指标。然而，在欧洲和日本，奥伦型复合试剂（TT）在华法林监测中也仍具有重要的临床应用价值。最近，一种利用家蚕杆状病毒系统表达的重组牛组织因子（TF）的TT试剂已被开发出来。本研究的目的是使用来自接受华法林治疗患者的53份血浆样本，研究PT（兔脑和重组人源）和TT（牛脑和重组牛源）在国际标准化比值（INR）中对凝血因子（FII、FV、FVII、FX）的敏感性，以及这些试剂之间的相关性。根据“直接”INR测定法，使用经认证的INR校准物“AK-CALIBRANT”计算INR结果。这些试剂对FII、FVII和FX的敏感性在INR中表现出相似的行为，但PT试剂对FV的敏感性通常高于TT试剂。重组PT和重组TT之间的相关系数为0.979。两种TT试剂（牛脑和重组牛源）在INR中的相关性良好（r = 0.998）。在临床病例中，很明显PT和TT之间的差异取决于华法林治疗过程中对FV水平的敏感性。总之，PT和TT试剂在INR中具有普遍可接受的相关性，我们的结果表明，根据世界卫生组织的建议，奥伦型TT试剂也非常适合使用当地INR校准来监测华法林。
