A Predictive Model for Area Under the Concentration versus Time Curve of Cyclosporin A Using Several Routine Monitoring Results in Renal Transplant Patients
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概要
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We created a predictive model for the area under the concentration versus time curve (AUC) of cyclosporin A (CsA) using routine monitoring results, and examined its clinical utility. Based on 48 clinical time courses accumulated from renal transplant patients, the AUC predictive model was created. An estimate of the AUC_<0-8> (integrated from time zero to 8 h) was then given as follows : AUC_<0-8>=5673.1×log(TL)+9342.8×log(OB)+64.1×D_<prd>×869.4×DTK-168.9×HCT-161.2×SCr-11.3×GPT+3.0×PL-588.6×SEX-24794.5. In this model, the AUC_<0-8>(ng・h/ml) is given as a function of the CsA trough levels (TL, ng/ml), obesity (OB, %), daily dose of prednisolone (D_<prd>, mg/d), donor type of kidney (DTK), hematocrit (HCT, %), serum creatinine (SCr, mg/dl), glutamate-pyruvate transaminase activity (GPT, IU/l), plasma lipids (PL, mg/dl) and sex distinction (SEX). The Statistical significance of this multiple regression was p_<0.00001 (R^2=0.862,n=48), and the day after transplantation, neither the administered oral dose of CsA, or the patient's age had any contribution to the regression. The predictive performance of this model was almost equal to that of the existing method which used 3-point data on the concentration versus time curve. In clinical adaptation for renal transplant patients, the steady-state concentration of CsA (C_<ss>) based on the AUC_<0-8> predictive model was significantly decreased during acute gastroenteritis or before acute rejection, whereas nephrotoxicity was increased, even though CsA trough levels were within a normal therapeutic range (100-200 ng/ml). These findings suggest that the created AUC_<0-8> predictive model using routine monitoring results, i.e., the trough level of CsA, biochemical tests, a daily dose of predorinsolone (PRD), and basic patient information, is convenient as a monitoring device for CsA therapy, and is satisfactory in clinical practice.
- 公益社団法人日本薬学会の論文
- 1997-08-15
著者
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Shibata Nobuhito
Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Womens College of Liber
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HAYAKAWA Taro
Department of Biochemistry, School of Dentistry, Aichi-Gakuin University
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Hayakawa T
National Institute Of Health Sciences
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MINOUCHI Tokuzo
Department of Hospital Pharmacy, of Shiga University of Medical Science
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YAMAJI Akira
Department of Hospital Pharmacy, of Shiga University of Medical Science
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Yamaji A
Department Of Hospital Pharmacy Of Shiga University Of Medical Science
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Yamaji Akira
Department Of Hospital Pharmacy Shiga University Of Medical Science
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Hoshino N
Department Of Hospital Pharmacy Shiga University Of Medical Science
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Hoshino Nobuo
Department Of Pharmacy Shiga University Of Medical Science
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Hayakawa T
National Inst. Health Sci. Tokyo Jpn
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Hayakawa Taro
Department Of Biochemistry School Of Dentistry Aichi-gakuin University
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Shibata Nobuhito
Dep. Of Pharmacokinetics Kyoto Pharmaceutical Univ.
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Hoshino Nobuo
Department Of Hospital Pharmacy Shiga University Of Medical Science
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Minouchi T
Department Of Hospital Pharmacy Of Shiga University Of Medical Science
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Minouchi Tokuzo
Hospital Pharmacy Shiga University Of Medical Science
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Shibata Nobuhito
Department Of Hospital Pharmacy Shiga University Of Medical Science
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Hazato Tadahiko
Department Of Medical Biology Tokyo Metropolitan Institute Of Medical Science
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Minouchi Tokuzo
Department Of Hospital Pharmacy Of Shiga University Of Medical Science
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Shibata Nobuhito
Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts
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