1. Construct a population pharmacokinetic/pharmacodynamic model of tacrolimus in kidney transplant patients, and explore the quantitative relationship between combination drugs and gene polymorphisms on the safety and efficacy of tacrolimus in kidney transplant patients; 2. Based on the established pharmacokinetic/pharmacodynamic model of tacrolimus population in kidney transplant patients, combined with combined drugs, gene polymorphisms and other factors for simulation, predict the steady-state trough concentration and efficacy of tacrolimus in kidney transplant patients taking triple drugs (tacrolimus, mycophenolate mofetil/mycophenol sodium enteric-coated tablets, glucocorticoids), and apply the model to the real world to explore the optimal initial dose and maintenance therapeutic dose of tacrolimus, so as to achieve individualized and precise treatment and guide the rational clinical use of drugs. 3. Clarify the value of precision medicine guided by population pharmacokinetics/pharmacodynamics models in clinical practice.
This is a retrospective study. It is proposed to combine the classical basic principles of pharmacokinetics with mathematical statistical models, and use nonlinear mixed effect model (NONMEM) or other population pharmacokinetics/pharmacodynamics software to establish a population pharmacokinetic/pharmacodynamic model of tacrolimus in kidney transplant patients, and elucidate the combination of drugs, demographic factors, pathophysiological factors, genotype, The quantitative effect of comorbid diseases and drugs on the steady-state trough concentration and efficacy of tacrolimus in kidney transplant patients, so as to realize individualized and precise treatment of kidney transplant patients through model simulation and prediction of steady-state trough concentration and efficacy after taking drugs.
Study Type
OBSERVATIONAL
Enrollment
120
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
RECRUITINGDrug plasma tough concentrations
The tough concentrations of tacrolimus are as regard as the PK parameters
Time frame: Blood samples were collected 30minutes before administration
Immune factors levels(CD4+、CD8+、CD4+/CD8+、CD4+%、CD8+%)
The Immune factors levels are as regard as the PD parameters
Time frame: The Immune factors levels were collected 30minutes before administration
Clinical indicators
Incidence of acute rejection,Incidence of tacrolimus adverse reactions and other advers are as regard as the PD parameters
Time frame: Follow-up after kidney transplantation was 6 months
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