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1 J Cardiol 2001 Dec; 38 6 : % Relationship Between Prothrombin Time International Normalized Ratio and Thrombo Test % Yuichi Yasuhiro Kenshiro Yutaka Tomio Hiroshi Hiroshi Takeshi NUMATA, MD OGATA, MD ARAO, MD MIZUMASA, MD 1 WAKITA, MD 1 HARUGUCHI, MD 1 ARAKI, MD 2 TSUJI, MD 2 Koshi MAWATARI, MD 3 Kazuyuki SHIMADA, MD, FJCC Abstract Objectives. 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 %. Methods. 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 ax 0.5 b, a natural logarithmic function Y a lnx b, a power series function Y ax b, a quotient function Y ab X, and polynomial functions Y a n X n a n 1 X n 1 a 1 X 1 b, 1 n 9. The results were confirmed by the same methods in 383 samples and 296 samples from another two laboratories. Results. The power series function showed the most significant p and highest adjusted R correlation, with a regression formula of TT % e 4.48 PT-INR 2.09 in our laboratory. Using the same analyses, the power series function also showed the most significant and highest adjusted R 2 in samples from the other two laboratories. Conclusions. 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 %. J Cardiol 2001 Dec ; 38 6 : Key Words Blood coagulation prothrombin time international normalized ratio, thrombo test Anticoagulants warfarin : ; 1 ; 2 ; 3 ; 4 Department of Cardiology, Japanese Red Cross Kumamoto Hospital, Kumamoto ; 1 Department of Cardiology, Taragi Municipal Hospital, Kumamoto ; 2 Department of Cardiology, Kamiamakusa General Hospital, Kumamoto ; 3 Department of Cardiology, Kagoshima Seikyo Hospital, Kagoshima ; 4 Department of Cardiology, Jichi Medical School, Tochigi Address for correspondence: NUMATA Y, MD, Department of Cardiology, Japanese Red Cross Kumamoto Hospital, Nagamineminami 2 1 1, Kumamoto, Kumamoto Manuscript received April 26, 2001; revised June 20 and September 12, 2001; accepted September 19,
2 328 prothrombin time : PTthrombo test : TT World Health Organization WHOPT international sensitivity index : ISI international normalized ratio : INR 1,2 PT- INR 3 8 PT-INR PT TT TT PT K TT protein induced by vitamin K antagonists or absence PIVKA TT PT TT PT 1,424 PT-INR 1,371 TT 1,072 TT INR TT TT PT-INR TT PT-INR TT PT-INR TT % PT-INR PT-INR TT % TT % 2 PT-INR TT % 1 PT-INR TT PT-INR TT % S ISI T ISI TH CA-5000 TT % 5% TT % TT % 5% ISI 2 PT-INR TT % Y a/x b Y ax 0.5 by a lnx b Y ax b Y ab X 1 9 Y a n X n a n 1 X n 1 a 1 X 1 b 1 n 9 n : Y TT % J Cardiol 2001 Dec; 38 6 :
3 329 X PT-INR Stat View ver p y Ax B X Y Y ax b TT % a PT-INR b ln TT % lna b ln PT-INR y ln TT % x ln PT-INR y bx lna x ln PT-INR y ln TT % b A lna B a e B TT % e PT-INR B A 3 2 PT-INR TT % 1383 PT-INR TT % C ISI ISI N CA PT-INR TT % C ISI CA TTO ISI N CA PT-INR TT % TT TT % TT % PT- INR PT TT TT TT-INR TT % TT TT-INR TT % PT TT PT-INR TT-INR PT % TT % 1 9 INR TT % Fig. 1 No. 4 Table :TT % e 4.48 PT-INR 2.09 p : J Cardiol 2001 Dec; 38 6 :
4 330 沼田 緒方 荒尾 ほか Fig. 1 Regression curves from the monomial and polynomial regression analyses of 505 samples from the Japanese Red Cross Kumamoto Hospital laboratory Each graph shows the correlation between PT-INR and TT %. Regression curves on graphs No. 1 No. 6 were derived from monomial regression analyses. The results of analyses were converted to a fractional function from graph No. 1, a square root function from No. 2, a natural logarithmic function from No. 3, a power series function from No. 4, and a quotient function from No. 5. Regression curves on No. 6 No. 14 were derived from monomial and polynomial regression analyses. TT thrombo test ; PT-INR prothrombin time international normalized ratio. J Cardiol 2001 Dec; 38 6 :
5 331 Table 1 Regression functions and adjusted R 2 derived from regression analyses using the 14 functions Japanese Red Cross Kumamoto Hospital, n 505 Functions Regression curves Y TT, X PT-INR p value Adjusted R 2 Fractional function Y 125.6/X 39.3 Square root function Y 88.4X Natural logarithmic functiony 66.7 lnx 73.9 Power series function Y e 4.5 X 2.1 Quotient function Y e 5.1 e 0.9 X Monomial function Y 26.9X 86.3 Polynomial functions Y 10.7X X Y 4.8X X X Y 1.9X X X X Y 0.8X X X X X Y 0.1X 6 3.0X X X X X Y 0.1X 7 2.1X X X X X X Y 0.1X 8 1.8X X X X X X X Y 0.04X 9 1.3X X X X X X X X Tables 2, 3 Table 4 TT TT-INR TT TT % TT TT % TT-INR PT TT INR % INR % 14 PT-INR TT % PT-INR TT % 14 PT-INR TT % 2 PT-INR TT % PT-INR TT % TT % PT-INR TT % PT-INR TT % PT-INR 15, PT-INR TT % X Y PT-INR TT % TT % PT-INR 0 1 TT % PT-INR Uetsuka 15 X Y TT % PT-INR TT % PT-INR J Cardiol 2001 Dec; 38 6 :
6 332 Table 2 Regression functions and adjusted R 2 derived from regression analyses using the 14 functions Kagoshima Seikyo Hospital, n 383 Functions Regression curves Y TT %, X PT-INR p value Adjusted R 2 Fractional function Square root function Y 98.1/X 33.3 Y X Natural logarithmic functiony 53.0 lnx 54.6 Power series function Quotient function Monomial function Polynomial functions Y e 4.2 X 2.1 Y e 4.9 e 1.0 X Y 24.1X 69.1 Y 17.5X X Y 14.1X X X Y 10.4X X X X Y 6.5X X X X X Y 5.3X X X X X X Y 3.9X X X X X X X Y 2.6X X X X X X X X Y 4.065X X X X X X X X X Table 3 Regression functions and adjusted R 2 derived from regression analyses using the 14 functions Taragi Municipal Hospital, n 296 Functions Regression curves Y TT %, X PT-INR p value Adjusted R 2 Fractional function Y 148.8/X 62.3 Square root function Y 109.8X Natural logarithmic functiony 80.2 lnx 71.8 Power series function Y e 4.5 X 2.5 Quotient function Y e 5.4 e 1.2 X Monomial function Y 35.4X 93.7 Polynomial functions Y 23.1X X Y 16.4X X X Y 13.1X X X X Y 9.7X X X X X Y 8.0X X X X X X Y 6.8X X X X X X X Y 4.9X X X X X X X X Y 0.2X 9 8.4X X X X X X X X J Cardiol 2001 Dec; 38 6 :
7 333 Table 4 Relationships between TT sec and TT-INR, TT % and TT %, TT % and TT-INR, TT sec and PT sec, TT-INR and PT-INR, and TT % and PT % Japanese Red Cross Kumamoto Hospital Regression curves p value Adjusted R 2 PT prothrombin time. Other abbreviations as in Fig TT % PT-INR PT-INR TT % TT TT TT % TT TT-INR TT- INR PT-INR 17 TT PT-INR TT % PT-INR TT % PT-INR TT TT % PT-INR TT % TT TT % TT % PT-INR 2 TT % PT-INR TT % PT-INR PT- INR TT % 86% 14% TT-INR TT % TT-INR TT % PT-INR TT % PT TT PT TT PT % TT % PT-INR TT-INR PT TT PT-INR TT-INR PT % TT % PT TT PT-INR TT-INR ISI PT % TT % PT-INR TT % TTTT % 2 3 % PT TTPT % TT % PT TT PT % TT % TT-INR TT ISI ISI J Cardiol 2001 Dec; 38 6 :
8 334 1 PT-INR TT % 14 PT-INR TT % TT % 4 TT % 2 PT-INR X TT % Y Y ax b PT- INR TT % PT-INR TT % PT-INR TT % TT % PT-INR TT % PT-INR TT % PT-INR TT % PT-INR : PT-INR TT PT- INR TT %PT-INR TT % : 505 PT-INR TT %PT-INR TT % 14 Y a/x b Y ax 0.5 b Y a lnx b Y ax b Y ab X 1 9 Y a n X n a n 1 X n 1 a 1 X 1 b 1 n : PT-INR TT % 14 p TT % e 4.48 PT-INR : 14 PT-INR TT % TT % PT-INR TT % J Cardiol 2001 Dec; 38 6 : J Cardiol 2001 Dec; 38 6 :
9 335 1 WHO Expert Committee on Biological Standardization : Thirty-third report. World Health Organ Tech Rep Ser 1983; 687: International Committee for Standardization in Haematology/International Committee on Thrombosis and Haemostasis : ICSH/ICTH recommendations for reporting prothrombin time in oral anticoagulant control. Blut 1985 ; 50 : Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B : Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation : The Copenhagen AFASAK study. Lancet 1989; : Atrial Fibrillation Investigators: Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation : Analysis of pooled data from five randomized controlled trials. Arch Intern Med 1994; 154: Connolly SJ, Laupacis A, Gent M, Roberts RS, Cairns JA, Joyner C : Canadian Atrial Fibrillation Anticoagulation CAFA Study. J Am Coll Cardiol 1991; 18 : Stroke Prevention in Atrial Fibrillation Investigators : Stroke Prevention in Atrial Fibrillation Study : Final results. Circulation 1991; 84 : Stroke Prevention in Atrial Fibrillation Investigators : Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation : Stroke Prevention in Atrial Fibrillation Study. Lancet 1994; 343: Stroke Prevention in Atrial Fibrillation Investigators : Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation : Stroke Prevention in Atrial Fibrillation randomised clinical trial. Lancet 1996 ; 348: Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG : Prevalence, age distribution, and gender of patients with atrial fibrillation: Analysis and implications. Arch Intern Med 1995; 155: Sudlow M, Thomson R, Thwaites B, Rodgers H, Kenny RA: Prevalence of atrial fibrillation and eligibility for anticoagulants in the community. Lancet 1998 ; 352 : Clinical Quality Improvement Network CQIN Investigators : Thromboembolic prophylaxis in 3575 hospitalized patients with atrial fibrillation. Can J Cardiol 1998 ; 14 : Stafford RS, Singer DE : National patterns of warfarin use in atrial fibrillation. Arch Intern Med 1996; 156 : Owren PA : Thrombotest a new method for controlling anticoagulant therapy. Lancet 1959; 7: : : 1999; pp Uetsuka Y, Hosoda S, Aosaki M, Iwade K, Koyanagi H, Ohki K, Hokari T, Inoue M, Akiyama E, Kitada M : Clinical significance of thrombotest and PT-INR in monitoring the oral anticoagulant therapy. Japanese Journal of Thrombosis and Hemostasis 1992 ; 3 : in Jpn with Eng abstr 16 : 1994 ; 169 : Uetsuka Y, Hosoda S, Kasanuki H, Aosaki M, Murasaki K, Ooki K, Inoue M, Akiyama E, Kitada M : Optimal therapeutic range for oral anticoagulants in Japanese patients with prosthetic heart valves: A preliminary report from a single institution using conversion from thrombotest to PT- INR. Heart Vessels 2000; 15 : J Cardiol 2001 Dec; 38 6 :
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