个体化给药辅助决策系统JPKD对肾移植受者他克莫司血药浓度预测能力评估  

Evaluation of the predictive ability of individualized drug administration adjuvant decision-making system JPKD for tacrolimus blood concentration in kidney transplant recipients

作　　者：颜辉 吴芙蓉 季鹏 沈爱宗 张圣雨 Yan Hui;Wu Furong;Ji Peng;Shen Aizong;Zhang Shengyu(Department of Pharmacy,the First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital),Hefei 230001,China)

机构地区：[1]中国科学技术大学附属第一医院(安徽省立医院)药学部,合肥230001

出　　处：《器官移植》2024年第4期630-636,共7页Organ Transplantation

基　　金：安徽省高等学校省级质量工程项目(2020jyxm2326)。

摘　　要：目的分析个体化给药辅助决策系统Java PK®for Desktop(JPKD)对肾移植受者他克莫司血药浓度的预测能力及影响因素。方法收集149例肾移植术后早期受者他克莫司血药浓度监测数据,使用JPKD预测他克莫司剂量调整后的血药谷浓度,计算实测浓度与预测浓度之间的绝对值权重偏差和相对预测误差。使用单因素和多因素logistic回归分析影响绝对权重偏差的相关因素,并绘制受试者工作特征(ROC)曲线评价影响因素对软件预测准确性的判断价值。结果收集149例患者266例次血药浓度数据,他克莫司血药浓度实测值为(6.5±3.0)ng/mL(1.1~16.6 ng/mL),JPKD进行计算的预测值为(5.6±2.5)ng/mL(1.4~14.4 ng/mL),计算结果的绝对权重偏差为28.38%,相对预测误差为−13.55%。单因素分析显示性别、白蛋白、红细胞比容变化、细胞色素P450(CYP)3A5*3基因型、C3435T基因型与预测结果不准确有关。多因素logistic回归分析显示CYP3A5*3基因型为AA、红细胞比容变化是影响JPKD预测他克莫司血药浓度准确性的独立危险因素。ROC曲线分析显示,红细胞比容变化>2.25%时,软件预测不准确的风险增加。结论JPKD用于预测肾移植受者他克莫司血药浓度具有一定的准确性,可以提高血药浓度的达标率,但CYP3A5*3基因型、红细胞比容变化会影响预测的准确性。Objective To evaluate the predictive ability and influencing factors of individualized drug administration adjuvant decision-making system Java PK®for Desktop(JPKD)for tacrolimus blood concentration in kidney transplant recipients.Methods The monitoring data of tacrolimus blood concentration from 149 recipients early after kidney transplantation were collected.The trough blood concentration of tacrolimus was predicted by JPKD.The absolute weighted deviation and relative prediction deviation between the actual and predicted concentration were calculated.The influencing factors of the absolute weighted deviation were analyzed by univariate and multivariate logistic regression analyses,and the predictive values of these influencing factors on the accuracy of software prediction were assessed by delineating the receiver operating characteristic(ROC)curve.Results Two hundred and sixty-six samples of tacrolimus blood concentration data were collected from 149 patients.The measured blood concentration of tacrolimus was(6.5±3.0)ng/mL(1.1-16.6 ng/mL),and the predicted value calculated by JPKD was(5.6±2.5)ng/mL(1.4-14.4 ng/mL).The absolute weighted deviation of the calculated data was 28.38%,and the relative prediction deviation was−13.55%.Univariate analysis showed that gender,albumin,changes in hematocrit,cytochrome P450(CYP)3A5*3 genotype and C3435T genotype were associated with the inaccurate prediction results.Multivariate logistic regression analysis found that CYP3A5*3 genotype of AA and the changes in hematocrit were the independent risk factors affecting the accuracy of tacrolimus blood concentration predicted by JPKD.ROC curve analysis showed that when the changes in hematocrit exceeded 2.25%,the risk of inaccurate software prediction was increased.Conclusions JPKD possesses certain accuracy in predicting the blood concentration of tacrolimus in kidney transplant recipients,which may improve the qualified rate of tacrolimus blood concentration.Nevertheless,CYP3A5*3 genotype and the changes of hematocrit may

关 键 词：肾移植 他克莫司 血药浓度 群体药代动力学 个性化给药辅助决策系统Java PK®for Desktop 治疗药物监测 细胞色素P450 红细胞比容 

分 类 号：R617[医药卫生—外科学] R979.5[医药卫生—临床医学]