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目的探讨有限采样法(limited sampling strategy,LSS)估算异基因造血干细胞移植预处理患者白消安血药浓度药时曲线下面积AUC0-360 min的可行性。方法以17名患者静脉输注白消安为研究对象,在首剂和第9剂给药时,分别于给药前及给药后不同时间点采集血样,用高效液相色谱法测定血浆白消安浓度,采用多元线性回归选取1~4个采样点建立LSS模型,选取最佳模型估算药动学参数。结果以2~4个血药浓度数据预测药动学参数回归模型的线性关系较好,静脉输注白消安第1剂量2~4次采样最佳回归模型分别是240,300 min和180,240,360 min及120,150,180,240 min所建立的模型。第9剂量2~4次采样的最佳回归模型分别是120,240 min和15,135,180 min及120,240,300,360 min所建立的模型。结论 LSS法估算静脉输注白消安制剂的药动学参数是可行的,可用于白消安的临床血药浓度监测。
Objective To investigate the feasibility of using the limited sampling method (LSS) to estimate the area under the curve of AUC0-360 min in patients receiving pretreatment with BSA for allogeneic hematopoietic stem cell transplantation. Methods A total of 17 patients received busulfan as the research object. When the first dose and the ninth dose were administered, blood samples were taken before administration and at different time points after administration, respectively, and plasma levels of plasma white Consuming concentration, the use of multiple linear regression select 1 to 4 sampling points to establish LSS model, select the best model to estimate pharmacokinetic parameters. Results Prediction of the linearity of the pharmacokinetic regression model with 2-4 blood concentration data was good. The best regression model of the first to second dose of busulfan intravenously was 240,300 min and 180,240,360 min and 120,150,180,240 min established model. The optimal regression model for the 2-4 doses of the 9th dose was established at 120, 240 min and 15, 135, 180 min and 120, 240, 300 and 360 min, respectively. Conclusions The LSS method is feasible to estimate the pharmacokinetic parameters of busulfan preparation. It can be used to monitor the plasma concentration of busulfan.