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目的:本研究拟通过量化他克莫司浓度个体化变异,以此评估他克莫司术后药物浓度波动度,进一步预测以此相关的移植术后排斥反应、感染等远期预后。方法:收集64名肾移植术后6个月后,患者连续6次药物浓度监测值。分别计算各患者的变异系数(CV),分为高变异组(20名)和低变异组(44名)。比较两组人群的男女比例、平均年龄、身高差异,绘制两组人群术后6个月连续6次后他克莫司谷浓度Tac C0和剂量矫正Tac C0曲线。回归分析计算两组的风险指数(OR)和95%置信区间(CI),以此评估两组肾移植患者术后预后。结果:两组患者年龄、男女比例、身高、体重及BMI值均无明显差异。高变异组比低变异组6次Tac C0及剂量矫正Tac C0值波动程度明显要大。回归分析发现,高变异组发生后期急性排斥反应、移植肾小球病或移植物丢失的风险指数为133,95%CI为0.87-2.37,而低变异组为1.84,95%CI为1.04-3.25。高变异组明显高于低变异组。结论:他克莫司浓度个体内变异的标准化定量可以衡量移植术后患者他克莫司药物浓度波动度,可作为衡量移植术后他克莫司药物浓度波动程度及相应风险预后的重要指标。
OBJECTIVE: This study aims to assess individualized variability of tacrolimus concentration in order to evaluate the fluctuation of drug concentration after tacrolimus, and to further predict the long-term prognosis of such rejection after transplantation. Methods: Six months after renal transplantation, 64 patients were monitored for six consecutive drug concentrations. The coefficient of variation (CV) of each patient was calculated and divided into high variation group (20) and low variation group (44). The proportions of men and women, mean age and height were compared between the two groups. The Tac C0 and Tac C0 curves of tacrolimus were plotted after 6 consecutive 6-months in both groups. Regression analysis calculated the risk index (OR) and 95% confidence interval (CI) of the two groups to evaluate the postoperative prognosis of the two groups of kidney transplant recipients. Results: There was no significant difference in age, male-female ratio, height, weight and BMI between the two groups. The degree of fluctuation of Tac C0 and Tac C0 in the high variation group was significantly higher than that in the low variation group. Regression analysis found that the risk index for acute rejection, glomerular graft disease or graft loss in the high-variant group was 133%, 95% CI 0.87-2.37, and 1.84 for the low-variance group 95% CI 1.04-3.25 . High variation group was significantly higher than the low variation group. CONCLUSIONS: The standardized quantification of intra-individual variation of tacrolimus concentration can measure the fluctuation of tacrolimus drug concentration in patients after transplantation, which can be used as an important index to measure the degree of tacrolimus drug concentration fluctuation and the corresponding risk prognosis after transplantation.