Numata Y, Ogata Y, Arao K, Mizumasa Y, Wakita T, Haruguchi H, Araki H, Tsuji T, Mawatari K, Shimada K
Department of Cardiology, Japanese Red Cross Kumamoto Hospital, Nagamineminami 2-1-1, Kumamoto, Kumamoto 862-8520.
J Cardiol. 2001 Dec;38(6):327-35.
The optimal therapeutic range for laboratory evaluation of oral anticoagulant therapy is now defined by the prothrombin time international normalized ratio (PT-INR). However, the thrombo test (TT), an alternative method to measure intensity of anticoagulation, is also currently used throughout Japan. The relationship between PT-INR and TT (%) has yet to be clarified. This study investigated the relationship between PT-INR and TT (%).
The PT-INR and TT (%) were simultaneously measured of 505 consecutive samples from patients treated with warfarin in our hospital. Fourteen functions were used for regression analyses: a fractional function (Y = a/X + b), a square root function (Y = aX0.5 + b), a natural logarithmic function (Y = a.lnX + b), a power series function (Y = aXb), a quotient function (Y = abX), and polynomial functions [Y = anXn + an - 1Xn - 1 +......+ a1X1 + b, (1 < or = n < or = 9)]. The results were confirmed by the same methods in 383 samples and 296 samples from another two laboratories.
The power series function showed the most significant (p < 0.0001) and highest adjusted R2 (0.858) correlation, with a regression formula of TT (%) = e4.48 (PT-INR)-2.09 in our laboratory. Using the same analyses, the power series function also showed the most significant and highest adjusted R2 in samples from the other two laboratories.
This study showed that a power series function is the most appropriate for expressing the relationship between PT-INR and TT (%) among the 14 functions. The function between PT-INR and TT (%) is mainly derived from the relationship between TT (%) and TT (sec). Both internal validity and external validity confirmed the relationship between PT-INR and TT (%).
目前,口服抗凝治疗实验室评估的最佳治疗范围由凝血酶原时间国际标准化比值(PT-INR)确定。然而,血栓弹力图试验(TT)作为一种测量抗凝强度的替代方法,目前在日本各地也被广泛使用。PT-INR与TT(%)之间的关系尚未明确。本研究调查了PT-INR与TT(%)之间的关系。
对我院接受华法林治疗患者的505份连续样本同时测定PT-INR和TT(%)。使用14种函数进行回归分析:分式函数(Y = a/X + b)、平方根函数(Y = aX0.5 + b)、自然对数函数(Y = a·lnX + b)、幂级数函数(Y = aXb)、商函数(Y = abX)以及多项式函数[Y = anXn + an - 1Xn - 1 +......+ a1X1 + b,(1 ≤ n ≤ 9)]。在另外两个实验室的383份样本和296份样本中用相同方法对结果进行了验证。
幂级数函数显示出最显著(p < 0.0001)且调整后R2最高(0.858)的相关性,在我们实验室的回归公式为TT(%) = e4.48 (PT-INR)-2.09。通过相同分析,幂级数函数在另外两个实验室的样本中也显示出最显著且调整后R2最高。
本研究表明,在这14种函数中,幂级数函数最适合表达PT-INR与TT(%)之间的关系。PT-INR与TT(%)之间的函数关系主要源自TT(%)与凝血时间(秒)之间的关系。内部效度和外部效度均证实了PT-INR与TT(%)之间的关系。