Elecsys与HPLC-MS/MS检测骨髓移植患者环孢素A血药浓度的相关性及其应用意义

目的探讨电化学发光(Elecsys)与液质联用(high performance liquid chromatography-tandem mass spectrometric，HPLC-MS/MS)检测骨髓移植患者环孢素A(Cyclosporin A，CSA)血药浓度的相关性，以建立两种方法更为准确合理的测定结果转换方法。 方法用Elecsys和HPLC-MS/MS分别测定83例骨髓移植患者CSA谷浓度，采用线性回归分析、结果平均值，以及正态分布法对两种方法测定结果进行比较分析，以考察两种方法的相关性；然后，用3种数据处理方法进行加权残差分析，验证3种统计学方法的准确性。 结果Elecsys与HPLC-MS/MS检测结果符合正态分布，测定CSA的平均值分别为139.2 ng/ml和149.7 ng/ml,且两种方法检测骨髓移植患者CSA血药浓度结果的差异均无统计学意义(t<0.01，P>0.05)。经线性回归分析(方程为Y=0.888X＋7.2696)，两种方法的相关性较好(r=0.999)；经3种数据分析方法所得换算系数分别为0.89、0.96和0.95。 结论Elecsys与HPLC-MS/MS检测骨髓移植患者CSA血药浓度的结果相近，无需用系数换算，医生和临床药师可根据检测结果直接进行骨髓移植患者CSA个体化给药方案调整。

Correlation of Elecsys and HPLC-MS/MS method in the determination of blood Cyclosporine A concentration in bone marrow transplant patients and its application

ObjectiveTo compare Elecsys and high performance liquid chromatographytandem mass spectrometric (HPLC-MS/MS) methods in measuring the blood Cyclosporine A (CSA) concentration of bone marrow transplant patients and to investigate the relationship of the results obtained from the two methods in order to establish a more accurate and reasonable conversion method. MethodsThe through concentration of CSA in 83 patients with bone marrow transplantation was measured by Elecsys and HPLC-MS/MS, respectively. The results from the two methods were analyzed by linear regression, and by the mean value and the normal distribution analyses in order to investigate the correlation of the two methods. Three data processing methods were performed to carry out weighted residual analysis and to verify the accuracy of the statistical methods. ResultsThe mean concentrations of CSA were 139.2 ng/ml and 149.7 ng/ml measured by Elecsys and HPLC-MS/MS methods, respectively. There was no significant difference between Elecsys and HPLC-MS/MS in the determination of CSA concentration (t<0.01, P>0.05). The results obtained by the two methods were in accorded with normal distribution. Linear regression analysis showed that the correlation between the two methods was better (Y=0.888X+ 7.2696, r=0.999). The conversion coefficients obtained by the three data processing methods were 0.89, 0.96 and 0.95, respectively. ConclusionsThe results of the blood CSA concentration in bone marrow transplantation patients obtained by Elecsys and HPLC-MS/MS are similar., and the conversion coefficient of the two methods is not needed. Doctors and clinical pharmacists can directly adjust the individualized dosing of CSA in patients undergoing bone marrow transplantation according to the either testing results.