摘要
目的评估JPKD、SmartDose、NextDose 3款个体化给药工具用于预测肾移植患者术后他克莫司给药剂量和血药浓度的准确性,并分析影响预测准确性的因素。方法回顾性纳入2021年1月-2023年6月在昆明市某三级甲等医院住院的肾移植术后使用他克莫司治疗的成年患者的临床资料。使用JPKD、SmartDose、NextDose 3款软件分别预测他克莫司给药剂量和血药浓度,计算实测值与预测值的绝对权重偏差(APE)、相对预测误差(PE)和预测良好率(APE<30%为预测效果良好);采用Pearson检验或Spearman检验分析3款软件预测给药剂量与实际给药剂量、血药浓度预测值与实测值的相关性,采用单因素方差分析考察影响3款软件预测准确性的因素。结果本研究共纳入110例住院患者,收集他克莫司给药剂量和血药浓度监测数据各193例次。JPKD、SmartDose、NextDose软件预测的他克莫司给药剂量分别为(2.0±0.7)、(2.7±1.9)、(1.8±0.8)mg,与实际给药剂量[(1.9±0.6)mg]的相关系数分别为0.841、0.450、0.247(P均小于0.001);APE中位数分别为6.00%、52.07%、30.40%,PE中位数分别为5.00%、18.50%、-3.50%,预测良好率分别为98.45%、30.05%、49.22%。上述3款软件预测的他克莫司血药浓度分别为(6.74±3.36)、(6.93±5.02)、9.00(5.80,12.60)ng/mL,与实测值[8.64(7.11,9.77)ng/mL]的相关系数分别为0.997、-0.066、0.920(P分别为<0.001、0.360、<0.001);APE中位数分别为5.54%、45.91%、35.56%,PE分别为-4.94%(中位数)、-17.05%(中位数)和36.93%(平均值),预测良好率分别为97.93%、32.64%、37.31%。单因素方差分析显示,给药剂量、血药浓度、体重、移植时间等与各软件的预测准确性有关(P<0.05)。结论3款个体化给药工具用于肾移植患者术后他克莫司给药剂量和血药浓度的预测良好率由高到低均为JPKD、NextDose、SmartDose软件,临床可优先考虑JPKD软件。
OBJECTIVE To evaluate the accuracy of three individualized drug delivery tools,i.e.JPKD,SmartDose and NextDose,in predicting tacrolimus dose and blood concentration after kidney transplantation,and analyze the influential factors of prediction accuracy.METHODS The clinical data of adult hospitalized patients treated with tacrolimus after kidney transplantation from January 2021 to June 2023 were retrospectively collected.Three individualized dosing tools,i.e.JPKD,SmartDose and NextDose,were used to predict the dose and plasma concentration of tacrolimus.The absolute prediction error(APE)and prediction error(PE)between the measured value and the predicted value,and prediction success rate were calculated(APE<30%indicating a good forecast).Pearson assay or Spearman assay was used to analyze the correlation between the predicted dosage and actual dosage,as well as the predicted and measured blood concentration values using three software;univariate analysis was used to investigate the influential factors for prediction accuracy of JPKD,SmartDose and NextDose.RESULTS A total of 110 hospitalized patients were included in this study,and 193 tacrolimus doses and plasma concentrations were monitored.The predicted doses of JPKD,SmartDose and NextDose were(2.0±0.7),(2.7±1.9),(1.8±0.8)mg,their measured value was(1.9±0.6)mg,and the correlation coefficients between the predicted values and the measured value were 0.841,0.450,0.247(P<0.001);the median APEs were 6.00%,52.07%and 30.40%,and the median PEs were 5.00%,18.50%and-3.50%;the prediction success rates were 98.45%,30.05%and 49.22%.The predicted values of tacrolimus concentrations using JPKD,SmartDose,NextDose were(6.74±3.36),(6.93±5.02),9.00(5.80±12.60)ng/mL,the measured value was 8.64(7.11,9.77)ng/mL,and the correlation coefficients between the predicted values and the measured value were 0.997(P<0.001),-0.066(P=0.360),0.920(P<0.001).The median APEs were 5.54%,45.91%and 35.56%,and PEs were-4.94%(median),-17.050%(median)and 36.93%(average value);the prediction succ
作者
王国徽
李兴德
潘娅
毛盼盼
张函舒
马雪娇
宋沧桑
WANG Guohui;LI Xingde;PAN Ya;MAO Panpan;ZHANG Hanshu;MA Xuejiao;SONG Cangsang(Dept.of Pharmacy,Kunming First People’s Hospital/Yunnan Provincial Research Center of Individualized Medication for Clinical Diseases,Kunming 650224,China)
出处
《中国药房》
CAS
北大核心
2024年第24期3023-3028,共6页
China Pharmacy
基金
云南省科技厅重大科技专项计划项目(No.202302AA310018)
云南省卫生健康委医学领军人才培养计划项目(No.L-2018012)
云南省卫生健康委临床药学中心建设项目
云南省临床药学中心开放课题(No.2023CPC001-A-2)
“春城计划”高层次人才创新创业团队专项(No.2022SCP002)。
