药代动力学/药效学模型在特殊人群抗菌药物治疗中的应用现状
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摘要
药代动力学/药效学(PK/PD)模型是将药代动力学和药效学结合起来研究的模型,用来描述和预测药物效应-时间过程并解释其原因,可应用于临床前和临床试验的各阶段,现已广泛用于抗菌药物的各方面研究。抗菌药物治疗中的特殊人群各自具有独特的病理、生理特征,因此临床中未能实现每位患者的个性化给药,而PK/PD模型是目前实现患者个性化给药的重要途径。本文将围绕PK/PD模型在特殊人群抗菌药物治疗中的应用进展进行综述。
The pharmacokinetic/pharmacodynamic( PK/PD) model is a model that combines pharmacokinetics and pharmacodynamics to describe and predict drug effects-time processes and explain their causes. It can be applied to various stages of preclinical and clinical trials and has been widely used in various aspects of antibacterial drugs. The special populations in antimicrobial treatment have their own unique pathological and physiological characteristics,so individualized regimen of each patient is not achieved in the clinic,and the PK/PD model is an important way to achieve personalized drug regimen. This article will review the application of PK/PD model in the treatment of antibiotics in special populations.
The pharmacokinetic/pharmacodynamic( PK/PD) model is a model that combines pharmacokinetics and pharmacodynamics to describe and predict drug effects-time processes and explain their causes. It can be applied to various stages of preclinical and clinical trials and has been widely used in various aspects of antibacterial drugs. The special populations in antimicrobial treatment have their own unique pathological and physiological characteristics,so individualized regimen of each patient is not achieved in the clinic,and the PK/PD model is an important way to achieve personalized drug regimen. This article will review the application of PK/PD model in the treatment of antibiotics in special populations.
引文
[1]MOSS D,MARZOLINI C,RAJOLI R,et al.Applications of physiologically based pharmacokinetic modeling for the optimization of anti-infective therapies[J].Expert Opin Drug Met,2015,11(8):1203-1217.
[2]GERMOVSEK E,BARKER C I S,SHARLAND M,et al.Pharmacokinetic-pharmacodynamic modeling in pediatric drug development,and the importance of standardized scaling of clearance[J].Clin Pharmacokinet,2018,18(3):1-14.
[3]KREKELS E,HASSELT J V,ANKER J V D,et al.Evidencebased drug treatment for special patient populations through modelbased approaches[J].Eur J Pharm Sci,2017,6(17):928-987.
[4]EUTENEUER J C,KAMATKAR S,FUKUDA T,et al.Suggestions for model-informed precision dosing to optimize neonatal drug therapy[J].J Clin Phramacol,2018,13(15):1-9.
[5]STOCKMANN C,BARRETT J,ROBERTS J,et al.Use of modeling and simulation in the design and conduct of pediatric clinical trials and the optimization of individualized dosing regimens[J].Cpt Pharmacometrics Systems Pharmacol,2016,4(11):630-640.
[6]SIME F B,ROBERTS M S,ROBERTS J A.Optimization of dosing regimens and dosing in special populations[J].Clin Microbiol Infec,2015,21(10):886-893.
[7]LEROUX S,ZHAO W,BETREMIEUX P,et al.Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based:a French national survey[J].Arch Dis Child,2015,100(4):394-398.
[8]KADAMBARI S,HEATH P T,SHARLAND M,et al.Variation in gentamicin and vancomycin dosage and monitoring in UK neonatalunits[J].J Antimicrob Chemoth,2011,66(11):2647-2650.
[9]SMITS A,DE COCK R F,ALLEGAERT K,et al.Prospective evaluation of a model-based dosing regimen for amikacin in preterm and term neonates in clinical practice[J].Antimicrob Agents Chemother,2015,59(10):6344-6351.
[10]JACQZ-AIGRAIN E,LEROUX S,ZHAO W,et al.How to use vancomycin optimally in neonates:Remaining questions[J].Expert Rev Clin Phar,2015,8(5):635-648.
[11]ALLEGAERT K,SIMONS S H P,TIBBOEL D,et al.Non-maturational covariates for dynamic systems pharmacology models in neonates,infants,and children:Filling the gaps beyond developmental pharmacology[J].Eur J Phram Sci,2017,8(17):928-987.
[12]ANNE S,PIETER A J G DE COCK.Antibiotic PK/PD research in critically ill neonates and children:how do we proceed[J].Int JPharmacokinet,2018,3(1):1-3.
[13]BRILL M J E,HOUWINK A P I,SCHMIDT S,et al.Reduced subcutaneous tissue distribution of cefazolin in morbidly obese versus non-obese patients determined using clinical microdialysis[J].J Antimicrob Chemother,2014,69(3):715-723.
[14]VINCENT J L,BASSETTI M,FRANCOIS,et al.Advances in antibiotic therapy in the critically ill[J].Critical Care,2016,20(1):1-13.
[15]ABDUL-AZIZ M H,DRIVER E,LIPMAN J,et al.New paradigm for rapid achievement of appropriate therapy in special populations:coupling antibiotic dose optimisation rapid microbiological methods[J].Expert Opin Drug Met,2018,14(7):693-760.
[16]PAI M P.Treatment of bacterial infections in obese adult patients:how to appropriately manage antimicrobial dosage[J].Curr Opin Pharmacol,2015,24(3):12-17.
[17]MINICHMAYR I K,ROBERTS J A,FREY O R,et al.Development of a dosing nomogram for continuous-infusion meropenem in critically ill patients based on a validated population pharmacokinetic model[J].J Antimicrob Chemother,2018,73(5):1330-1339.
[18]CHRISTOPHER R J,MORGAN M E,TANG Y,et al.Pharmacokinetics and tolerability of lorcaserin in special populations:Elderly patients and patients with renal or hepatic impairment[J].Clin Therapeutics,2017,39(4):1-19.
[19]MONIQUE R B,THOMAS P L,THOMAS P L,et al.Suboptimal clinical response rates with newer antibiotics among patients with moderate renal impairment:review of the literature and potential pharmacokinetic and pharmacodynamic considerations for observed findings[J].Review Therapeutics,2018,11(7):1380-1407.
[20]BOSCIA J A,KORZENIOWSKI O M,SNEPAR R,et al.Cefoperazone pharmacokinetics in normal subjects and patients with cirrhosis[J].Antimicrob Agents Chemother,1983,23(3):385-389.
[21]TOUNY M E,GUINAIDY M E,BARRY M A,et al.Pharmacokinetics of aztreonam in patients with liver cirrhosis and ascites[J].JAntimicrob Chemother,1992,30(30):387-395.
[22]ALDAZ A,ORTEGA A A,GIRALDEZ J,et al.Effects of hepatic function on vancomycin pharmacokinetics in patients with cancer[J].Ther Drug Monit,2000,22(3):250-257.
[2]GERMOVSEK E,BARKER C I S,SHARLAND M,et al.Pharmacokinetic-pharmacodynamic modeling in pediatric drug development,and the importance of standardized scaling of clearance[J].Clin Pharmacokinet,2018,18(3):1-14.
[3]KREKELS E,HASSELT J V,ANKER J V D,et al.Evidencebased drug treatment for special patient populations through modelbased approaches[J].Eur J Pharm Sci,2017,6(17):928-987.
[4]EUTENEUER J C,KAMATKAR S,FUKUDA T,et al.Suggestions for model-informed precision dosing to optimize neonatal drug therapy[J].J Clin Phramacol,2018,13(15):1-9.
[5]STOCKMANN C,BARRETT J,ROBERTS J,et al.Use of modeling and simulation in the design and conduct of pediatric clinical trials and the optimization of individualized dosing regimens[J].Cpt Pharmacometrics Systems Pharmacol,2016,4(11):630-640.
[6]SIME F B,ROBERTS M S,ROBERTS J A.Optimization of dosing regimens and dosing in special populations[J].Clin Microbiol Infec,2015,21(10):886-893.
[7]LEROUX S,ZHAO W,BETREMIEUX P,et al.Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based:a French national survey[J].Arch Dis Child,2015,100(4):394-398.
[8]KADAMBARI S,HEATH P T,SHARLAND M,et al.Variation in gentamicin and vancomycin dosage and monitoring in UK neonatalunits[J].J Antimicrob Chemoth,2011,66(11):2647-2650.
[9]SMITS A,DE COCK R F,ALLEGAERT K,et al.Prospective evaluation of a model-based dosing regimen for amikacin in preterm and term neonates in clinical practice[J].Antimicrob Agents Chemother,2015,59(10):6344-6351.
[10]JACQZ-AIGRAIN E,LEROUX S,ZHAO W,et al.How to use vancomycin optimally in neonates:Remaining questions[J].Expert Rev Clin Phar,2015,8(5):635-648.
[11]ALLEGAERT K,SIMONS S H P,TIBBOEL D,et al.Non-maturational covariates for dynamic systems pharmacology models in neonates,infants,and children:Filling the gaps beyond developmental pharmacology[J].Eur J Phram Sci,2017,8(17):928-987.
[12]ANNE S,PIETER A J G DE COCK.Antibiotic PK/PD research in critically ill neonates and children:how do we proceed[J].Int JPharmacokinet,2018,3(1):1-3.
[13]BRILL M J E,HOUWINK A P I,SCHMIDT S,et al.Reduced subcutaneous tissue distribution of cefazolin in morbidly obese versus non-obese patients determined using clinical microdialysis[J].J Antimicrob Chemother,2014,69(3):715-723.
[14]VINCENT J L,BASSETTI M,FRANCOIS,et al.Advances in antibiotic therapy in the critically ill[J].Critical Care,2016,20(1):1-13.
[15]ABDUL-AZIZ M H,DRIVER E,LIPMAN J,et al.New paradigm for rapid achievement of appropriate therapy in special populations:coupling antibiotic dose optimisation rapid microbiological methods[J].Expert Opin Drug Met,2018,14(7):693-760.
[16]PAI M P.Treatment of bacterial infections in obese adult patients:how to appropriately manage antimicrobial dosage[J].Curr Opin Pharmacol,2015,24(3):12-17.
[17]MINICHMAYR I K,ROBERTS J A,FREY O R,et al.Development of a dosing nomogram for continuous-infusion meropenem in critically ill patients based on a validated population pharmacokinetic model[J].J Antimicrob Chemother,2018,73(5):1330-1339.
[18]CHRISTOPHER R J,MORGAN M E,TANG Y,et al.Pharmacokinetics and tolerability of lorcaserin in special populations:Elderly patients and patients with renal or hepatic impairment[J].Clin Therapeutics,2017,39(4):1-19.
[19]MONIQUE R B,THOMAS P L,THOMAS P L,et al.Suboptimal clinical response rates with newer antibiotics among patients with moderate renal impairment:review of the literature and potential pharmacokinetic and pharmacodynamic considerations for observed findings[J].Review Therapeutics,2018,11(7):1380-1407.
[20]BOSCIA J A,KORZENIOWSKI O M,SNEPAR R,et al.Cefoperazone pharmacokinetics in normal subjects and patients with cirrhosis[J].Antimicrob Agents Chemother,1983,23(3):385-389.
[21]TOUNY M E,GUINAIDY M E,BARRY M A,et al.Pharmacokinetics of aztreonam in patients with liver cirrhosis and ascites[J].JAntimicrob Chemother,1992,30(30):387-395.
[22]ALDAZ A,ORTEGA A A,GIRALDEZ J,et al.Effects of hepatic function on vancomycin pharmacokinetics in patients with cancer[J].Ther Drug Monit,2000,22(3):250-257.