中华临床医师杂志(电子版) 2017年2月,11卷3期

临床论著

环孢素A血药浓度检测方法比较分析

王磊 孙文利 李培余 田萌苏 陈雪 张阳 刘红星

065201 河北燕达医院陆道培血液肿瘤中心
刘红星,Email: lhongxing@outlook.com

摘要:目的 比较电化学发光法(Elecsys)、化学发光微粒子免疫法(CMIA)及液质联用(HPLC-MS/MS)法监测环孢素A(CSA)血药浓度的相关性。方法 收集101例服用环孢素A达稳态的骨髓移植患者全血样本,分别用3种方法进行测定并进行评价。结果 3种测定方法的相关性良好,Elecsys法与HPLC-MS/MS的检测结果相关系数r为0.99,CMIA法与HPLC-MS/MS的检测结果相关系数r为0.92,Elecsys法与CMIA法的检测结果相关系数r为0.91,但CMIA检测结果明显高于Elecsys和HPLC-MS/MS,t值分别为1.97×10-4和7.49×10-6,差异有统计学意义;而Elecsys和HPLC-MS/MS检测结果比较差异无统计学意义(t=0.39,P>0.05)。结论 三种方法的检测结果相关性好。HPLC-MS/MS与Elecsys法检测结果可以根据相应的回归方程互算,而HPLC-MS/MS与CMIA法检测结果不可直接进行换算。

关键词:环孢素; 电化学发光法; 化学发光微粒子免疫法; 液质联用

Comparative analysis of cyclosporine blood concentration detection methods

Wang Lei, Sun Wenli, Li Peiyu, Tian Mengsu, Chen Xue, Zhang Yang, Liu Hongxing.

Hebei Yanda Lu Daopei Hospital, Langfang 065201, China
Liu Hongxing, Email: lhongxing@outlook.com

Abstract:  Objective To compare electrochemiluminescence (Elecsys), chemiluminescent microparticle immunosorbent assay (CMIA), liquid chromatography-mass spectrometry (HPLC-MS/MS) method for the determination of cyclosporine in blood and to evaluate the correlations among three methods. Methods One hundred and one steady-state blood samples were collected from bone marrow transplant patients who had taken cyclosporine. Three methods were employed to determine the concentration and evaluated. Results The results determined by three methods had high correlation. Correlation coefficient between Elecsys and HPLC-MS/MS was 0.99, CMIA and HPLC-MS/MS was 0.92, CMIA and Elecsys was 0.91. However, the test result of CMIA was significantly higher than Elecsys and HPLC-MS/MS, t values were 1.97×10-4 and 7.49×10-6 respectively, there was very significant difference between the two methods; and Elecsys and HPLC-MS/MS had no significant difference (t=0.39). Conclusions The test results of three methods have good correlation. The test results of HPLC-MS/MS and Elecsys method can be calculated according to the corresponding regression equation, but the test results of HPLC-MS/MS and CMIA can not be directly converted.

Keywords:Cyclosporine; Elecsys; CMIA; HPLC-MS/MS

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(编辑:梁雷 收稿日期:2016-09-21)