Limited sampling strategy for the estimation of the area under the concentration-time curve for ganciclovir in Chinese adult renal allograft recipients

التفاصيل البيبلوغرافية
العنوان: Limited sampling strategy for the estimation of the area under the concentration-time curve for ganciclovir in Chinese adult renal allograft recipients
المؤلفون: Shan-Shan Hu, Kun Shao, Wen-Bin Rui, Xiao-Hui Zhai, Jia-Qian Lu, Hui-Min An, Pei-jun Zhou, Bing Chen
المصدر: European Journal of Clinical Pharmacology. 75:677-686
بيانات النشر: Springer Science and Business Media LLC, 2019.
سنة النشر: 2019
مصطلحات موضوعية: Adult, Male, Ganciclovir, medicine.medical_specialty, Adolescent, Cmax, Urology, Antiviral Agents, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Asian People, Pharmacokinetics, Linear regression, Humans, Transplantation, Homologous, Valganciclovir, Medicine, Pharmacology (medical), 030212 general & internal medicine, Pharmacology, Blood Specimen Collection, medicine.diagnostic_test, business.industry, General Medicine, Middle Aged, Stepwise regression, Kidney Transplantation, Therapeutic drug monitoring, Area Under Curve, Cytomegalovirus Infections, Renal allograft, Female, Drug Monitoring, business, Immunosuppressive Agents, medicine.drug
الوصف: Valganciclovir (VGCV) treatment is recommended for the prevention of cytomegalovirus (CMV) infection in renal allograft recipients. The aim of the present study is to investigate the pharmacokinetic characteristics of ganciclovir (GCV) after administration of VGCV in Chinese adult renal allograft recipients and estimate the exposure to GCV using limited sampling strategy (LSS). Forty Chinese renal allograft recipients were given 450 mg or 900 mg VGCV daily. Blood samples were drawn before treatment and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 h after 5 days of VGCV therapy, and the plasma concentrations of VGCV and GCV were determined using a liquid chromatography-mass spectrometry assay. The major pharmacokinetic parameters for GCV and VGCV were determined using a noncompartmental assay. Multiple stepwise linear regression analysis was conducted to establish a model equation for the estimation of the GCV AUC0–24 h in Chinese patients using LSS. In the 450 and 900 mg groups, the Cmax for VGCV was 0.2 ± 0.10 and 0.4 ± 0.16 mg/L, respectively; the Cmax for GCV was 4.2 ± 1.1 and 8.6 ± 1.6 mg/L, respectively; and the AUC0–24 h for GCV was 28.4 ± 8.4 and 60.7 ± 17.5 mg·h/L, respectively. For the establishment of LSS models, 40 patients were divided into the training group (n = 24) and validation group (n = 16). The model equations used for the calculation of AUC0–24 h for GCV were established in the training group by using multiple linear regression assay. Equations including AUC = 8.1 + 29.7 × C0 + 5.7 × C4 (r2 = 0.91) and AUC = − 0.4 + 11.0 × C0 + 2.1 × C2 + 13.7 × C8 (r2 = 0.98) were acceptable. The %MPE and %MAPE values obtained from the validation group for the two model equations were 5.89 ± 14.5% and 12.1 ± 9.53%, and − 1.30 ± 4.40% and 3.28 ± 3.11%, respectively. The LSS models that included C0 and C4 or C0, C2, and C8 in the estimation of AUC0–24 h for GCV had favorable performance and can be used for therapeutic drug monitoring in the prevention of CMV infection using VGCV in Chinese renal allograft recipients.
تدمد: 1432-1041
0031-6970
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5a7190a7686604938efa29ab2e2e1e1
https://doi.org/10.1007/s00228-018-02613-w
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....e5a7190a7686604938efa29ab2e2e1e1
قاعدة البيانات: OpenAIRE