Population pharmacokinetics of tacrolimus in paediatric systemic lupus erythematosus based on real-world study

Wang, D.-D.; Lu, Jin; Li, Q.; Li, Z.-P.

doi:10.1111/jcpt.12707

Cited by 22 publications

(47 citation statements)

References 43 publications

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“…One explanation is that tacrolimus accumulates widely in erythrocytes and plasma proteins. As patients regained their health, plasma proteins and erythrocytes gradually increased with time, which explains our result of the increasing V / F with increased post‐transplant day with tacrolimus.…”

Section: Discussionsupporting

confidence: 51%

“…Therefore, our PK parameters mainly included apparent oral clearance (CL/ F ) and volume of distribution ( V / F ). K a , the absorption rate constant of the model, was fixed at 4.48 h −1 …”

Section: Methodsmentioning

confidence: 99%

“…The stepwise covariate model and likelihood ratio examine were used for comparing hierarchical models. Objective function values (OFV) changes were produced by covariate inclusions, and a decrease in OFV of more than 3.84 ( P < 0.05) was considered the inclusion standard for covariates in the base model . After establishing a full regression model, it was ulteriorly assessed by abandoning covariates from each PK parameter one by one to obtain the final model.…”

Section: Methodsmentioning

confidence: 99%

“…After establishing a full regression model, it was ulteriorly assessed by abandoning covariates from each PK parameter one by one to obtain the final model. An increase in OFV of more than 6.64 ( P < 0.01) was considered the standard for significant relationships in the final model …”

Section: Methodsmentioning

confidence: 99%

“…Fortunately, population pharmacokinetics (PPK) can gather useful information from the limited data of patients . Moreover, PPK analysis differentiates interindividual and intraindividual variabilities . Therefore, compared with the traditional pharmacokinetic (PK) method, PPK is more reliable to confirm the effects of various elements about pharmacokinetics, making it convenient to define a rational dosage regimen.…”

Section: What Is Known and Objectivesmentioning

confidence: 99%

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Wuzhi capsule and haemoglobin influence tacrolimus elimination in paediatric kidney transplantation patients in a population pharmacokinetics analysis: A retrospective study

Wang

Chen

2019

J Clin Pharm Ther

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Summary What is known and objectives Tacrolimus is widely used for kidney transplantation in children. However, the narrow therapeutic window and considerable interindividual and intraindividual variabilities make tacrolimus untoward to design an optimum dosage for paediatric personalized medicine. Our research aims to establish the tacrolimus population pharmacokinetics (PPK) of Chinese paediatric kidney transplantation patients and to distinguish covariates impacting variabilities. Methods Chinese paediatric kidney transplantation patients treated with tacrolimus between January 2014 and April 2018 from Children's Hospital of Fudan University were retrospectively analysed. A total of 51 Chinese paediatric kidney transplantation patients were analysed using non‐linear mixed effects modelling (NONMEM). The effects of population characteristics, biological features and drug combination were assessed. The final PPK model was evaluated using visual inspection of routine diagnostic plots and the internal validation method of bootstrap. Results Our data met the condition of a one‐compartment model, and the final model was CL/F = 32.7 × (WT/70)0.75 × (1 – WZ × 0.341) × (HGB/97)−0.508; V/F = 1890 × (WT/70) × (POD/57)0.816, where WT, WZ, HGB and POD were weight, Wuzhi capsule (extracted from schisandra sphenanthera, whose primary efficient constituents are schisantherin A, schisandrol B, schisandrin etc, and often used to treat drug‐induced hepatitis in Chinese organ transplant patients), haemoglobin and post‐transplant day, respectively. What is new and conclusion The tacrolimus PPK model in Chinese paediatric kidney transplantation patients was developed, and Wuzhi capsule and haemoglobin influence tacrolimus elimination in paediatric kidney transplantation patients.

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Section: Discussionsupporting

confidence: 51%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: What Is Known and Objectivesmentioning

confidence: 99%

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Wuzhi capsule and haemoglobin influence tacrolimus elimination in paediatric kidney transplantation patients in a population pharmacokinetics analysis: A retrospective study

Wang

Chen

2019

J Clin Pharm Ther

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Population Pharmacokinetics of Tacrolimus in Pediatric Patients With Umbilical Cord Blood Transplant

Zuo

Shang

et al. 2022

The Journal of Clinical Pharma

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Tacrolimus was frequently used in pediatric patients with umbilical cord blood transplant for the prevention of graft-versus-host disease. The aim of the present study was to evaluate the population pharmacokinetics of tacrolimus among pediatric patients with umbilical cord blood transplant and find potential influenced factors. A total of 275 concentrations from 13 pediatric patients were used to build a polulation pharmacokinetic model using a nonlinear mixed-effects modeling approach. The impact of demographic features, biological characteristics, and concomitant medications, including sex, age, body weight, postoperative day, white blood cell count, red blood cell count, hemoglobin, platelets, hematocrit, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, total bilirubin, albumin, and total protein were investigated. The pharmacokinetics of tacrolimus were best described by a 1-compartment model with first-and zero-order mixed absorption and first-order elimination. The clearance and volume of distribution of tacrolimus were 1.93 L/h and 75.1 L, respectively. A covariate analysis identified that postoperative day and co-administration with trimethoprim-sulfamethoxazole were significant covariates influencing clearance of tacrolimus. Frequent blood monitoring and dose adjustment might be needed with the prolongation of postoperative day and coadministration with trimethoprim-sulfamethoxazole.

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Population pharmacokinetic analyses of tacrolimus in non-transplant patients: a systematic review

Wang

Zhang

Zhao

et al. 2023

Eur J Clin Pharmacol

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Population pharmacokinetics of tacrolimus in paediatric systemic lupus erythematosus based on real-world study

Abstract: The first validated tacrolimus PPK model in patients with PSLE is presented.

Cited by 22 publications

References 43 publications

Wuzhi capsule and haemoglobin influence tacrolimus elimination in paediatric kidney transplantation patients in a population pharmacokinetics analysis: A retrospective study

Wuzhi capsule and haemoglobin influence tacrolimus elimination in paediatric kidney transplantation patients in a population pharmacokinetics analysis: A retrospective study

Population Pharmacokinetics of Tacrolimus in Pediatric Patients With Umbilical Cord Blood Transplant

Population pharmacokinetic analyses of tacrolimus in non-transplant patients: a systematic review

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