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Population pharmacokinetic study of cyclosporine in Chinese renal transplant recipients.
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- Author(s): Chen, Bing; Zhang, WeiXia; Gu, ZhiDong; Li, Juan; Zhang, YuXin; Cai, WeiMin
- Source:
European Journal of Clinical Pharmacology; Jun2011, Vol. 67 Issue 6, p601-612, 12p, 4 Charts, 5 Graphs- Subject Terms:
ADRENOCORTICAL hormones; ANALYSIS of variance; ANTI-inflammatory agents; CHI-squared test; CHINESE people; COMPUTER software; CONFIDENCE intervals; CYCLOSPORINE; GENES; GENETIC polymorphisms; GOODNESS-of-fit tests; GRAFT rejection; GRAFT rejection prevention; IMMUNOSUPPRESSIVE agents; KIDNEY transplantation; NONPARAMETRIC statistics; OXIDOREDUCTASES; RESEARCH funding; DATA analysis; DRUG administration; DRUG dosage - Source:
- Additional Information
- Subject Terms:
- Abstract: Purpose: To establish the population pharmacokinetic (PPK) model of cyclosporine (CsA) in Chinese renal transplant recipients and evaluate the influence of various indexes including CYP3A5 and MDR1 genetic polymorphism on pharmacokinetic parameters. Methods: Trough (C) and peak (C) CsA concentration were monitored conventionally after renal transplantation. C and C were collected for 5 months in 146 patients. The CYP3A5*3 genotype and MDR1 haplotype were determined by methods based on amplification refractory mutant PCR. The data were analyzed by nonlinear mixed-effect modeling (NONMEM). The model was evaluated using goodness of fit plots and relative error measurements. Physiological and pathological factors including CYP3A5 and MDR1 genotypes were evaluated as covariates of CsA pharmacokinetic parameters. Results: Pharmacokinetics of CsA was best described by a one-compartment disposition model followed a first-order absorption process. The estimated clearance (CL/F) was 49.5 l·h, the volume of distribution (Vd/F) was 226 l. K was fixed as 1.25 h. Post-transplant data, body weight, total bilirubin, and MDR1 genotype were covariates of CL/F ( P < 0.005). Gender and MDR1 haplotype were covariates of Vd/F ( P < 0.005). The AUC estimated based on the Bayesian method was 7,465 ± 1,708 ng·h·ml (2,946 ∼13,926 ng·h·ml). Conclusion: The PPK model developed in this study could be used to optimize CsA dose for Chinese renal transplant recipients by using conventional therapeutic drug monitoring (TDM) data. [ABSTRACT FROM AUTHOR]
- Abstract: Copyright of European Journal of Clinical Pharmacology is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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