JPKD软件预测肾移植患者环孢素血药浓度的实践  

Application of JPKD Software in Predicting Cyclosporine Blood Concentration in Renal Transplant Patients

作　　者：师亚玲 王慧 廉江平[1] 李茁[1] 张鹏[1] SHI Yaling;WANG Hui;LIAN Jiangping;LI Zhuo;ZHANG Peng(Shaanxi Provincial People's Hospital,Xi'an,Shaanxi,China 710068)

机构地区：[1]陕西省人民医院,陕西西安710068

出　　处：《中国药业》2023年第15期50-54,共5页China Pharmaceuticals

基　　金：陕西省重点研发计划项目[2019SF-188];2021年陕西省人民医院科技人才支持计划资助项目[2021JY-30];2021年陕西省人民医院科技发展孵化基金资助项目[2021YJY-36]。

摘　　要：目的探讨以群体药代动力学模型为基础开发的个体化软件(简称JPKD软件)对肾移植患者环孢素血药浓度的预测能力,并分析导致偏差的原因。方法收集医院2020年1月至2021年12月的肾移植术后4个月口服环孢素并监测血药浓度的住院患者202例,监测环孢素血药浓度268例次,根据环孢素血药是否达标(80.0~250.0 ng/mL),分为3组。采用单因素和多因素分析环孢素血药浓度未达标的影响因素。采用JPKD软件预测理论血药浓度,采用散点图、Pearson双变量分析和Bland-Altman法检验分析结果的相关性和一致性;采用权重偏差(WRES)评估JPKD软件的预测能力。结果268例次肾移植患者环孢素血药浓度达标率为38.06%(102/268),重复测定环孢素血药浓度66例次。单因素分析结果显示,年龄、用药时长、红细胞计数、血红蛋白、丙氨酸氨基转移酶、总胆红素、尿素氮、肌酐、视黄醇结合蛋白和半胱氨酸蛋白酶抑制剂-C是环孢素血药浓度未达标的影响因素;多因素分析结果显示,影响环孢素血药浓度的主要因素为年龄、血红蛋白、丙氨酸氨基转移酶、总胆红素。散点图、Pearson双变量分析和BlandAltman法结果显示,66次例患者中JPKD预测环孢素血药浓度与实际浓度具有相关性(r=0.53,P<0.01),64例次(96.97%)均在一致性界范围内(-120.16,134.81)。WRES<30%的有38例次(57.58%)。年龄、肌酐、丙氨酸氨基转移酶是JKPD软件预测环孢素血药浓度准确性的影响因素。结论环孢素血药浓度达标受年龄、血红蛋白、丙氨酸氨基转移酶、总胆红素等因素影响。JPKD软件对环孢素血药浓度有一定的预测能力。Objective To investigate the predictive ability of Java PK®for Desktop(JPKD software)for cyclosporine blood concentration in renal transplant patients,and to analyze the causes of the deviation.Methods A total of 202 inpatients who took cyclosporine orally and monitored blood concentration during four months after kidney transplantation from January 2020 to December 2021 were collected,and 268 cases of cyclosporine blood concentration were monitored.The patients were divided into three groups according to whether the cyclosporine blood concentration reached the standard(80.0-250.0 ng/mL).Univariate analysis and multivariate analysis were used to analyzed the influencing factors of unqualified cyclosporine blood concentration.JPKD software was used to predict the theoretical concentrations.The correlation and consistency of the analysis results were tested by the scatter plot,Pearson bivariate analysis,and Bland-Altman method.The predictive ability of JPKD software was evaluated by weighted residual(WRES).Results The standard-reaching rate of cyclosporine blood concentration in 268 renal transplant patients was 38.06%(102/268),and the cyclosporine blood concentration was repeatedly measured in 66 cases.The results of the univariate analysis showed that age,duration of medication,red blood cell count,hemoglobin,alanine aminotransferase,total bilirubin,blood urea nitrogen,creatinine,retinol-binding protein and cysteine protease inhibitor C were the factors affecting the unqualified cyclosporine blood concentration.The results of the multivariate analysis showed that the main factors affecting the cyclosporine blood concentration were age,hemoglobin,alanine aminotransferase and total bilirubin.The results of the scatter plot,Pearson bivariate analysis and Bland-Altman method showed that the predicted JPKD concentration was correlated with the measured concentration in 66 cases(r=0.53,P<0.01),with 64 cases(96.97%)of them within the consistency limit(-120.16,134.81).There were 38 cases(57.58%)with WRES<30%.Age,creatin

关 键 词：肾移植 环孢素 治疗药物监测 影响因素 以群体药代动力学模型为基础开发的个体化软件 

分 类 号：R969[医药卫生—药理学] R979.5[医药卫生—药学]