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目的:比较微粒子酶联免疫方法(MEIA)方法和高效液相色谱法(HPLC)检测全血雷帕霉素浓度,评价MEIA方法的可靠性。方法:采集65份用雷帕霉素进行治疗的肾移植受者的全血标本,并用2种方法检测其血药浓度。结果:2种方法的回收率、精密度、检测范围和线性都比较理想,2种方法检测结果的r=0.861,斜率1.6776,截距+0.3832,MEIA测得的药物质量浓度均值(7.4μg.L-1)比HPLC方法测得的均值(4.2μg.L-1)高。结论:MEIA方法与作为参照的HPLC方法相关性良好,其结果出现阳性偏移主要是由于药物代谢产物的交叉反应。MEIA方法简单、快速,可以作为临床应用检测雷帕霉素血药浓度的选择。
OBJECTIVE: To compare the concentration of rapamycin in whole blood with MEIA and HPLC to evaluate the reliability of MEIA. METHODS: Sixty-five whole blood samples from renal transplant recipients treated with rapamycin were collected and tested for plasma concentrations using two methods. Results: The recovery rate, precision, detection range and linearity of the two methods were all ideal. The results of two methods were r = 0.861, slope of 1.6776, intercept + 0.3832, MEIA mean of drug concentration (7.4μg. L-1) was higher than the mean (4.2 μg.L-1) measured by the HPLC method. CONCLUSION: The MEIA method correlates well with the HPLC method used as a reference, and the positive shift in results is mainly due to the cross-reactivity of the drug metabolites. The MEIA method is simple and rapid and can be used as a clinical choice to determine the plasma concentration of rapamycin.