3种方法检测霉酚酸血药浓度的一致性与差异性比较  

Comparison of the Consistency and Difference of Three Detection Methods in Blood Concentration Monitoring of Mycophenolic Acid

作　　者：吕凤俊[1] 李思[1] 孙凤军 樊继山[1] LYU Fengjun;LI Si;SUN Fengjun;FAN Jishan(Dept.of Pharmacy,Children’s Hospital of Chongqing Medical University/National Clinical Research Center for Child Health and Disorders/Ministry of Education Key Laboratory of Child Development and Disorders/Chongqing Key Laboratory of Pediatrics,Chongqing 400014,China;Dept.of Pharmacy,the First Affiliated Hospital of Army Medical University,Chongqing 400038,China)

机构地区：[1]重庆医科大学附属儿童医院药学部/国家儿童健康与疾病临床医学研究中心/儿童发育疾病研究教育部重点实验室/儿科学重庆市重点实验室,重庆400014 [2]陆军军医大学附属第一医院药学部,重庆400038

出　　处：《中国药房》2021年第23期2885-2889,共5页China Pharmacy

基　　金：重庆市科卫联合医学科研项目(No.2020MSXM069)。

摘　　要：目的:探讨荧光免疫层析法与液相色谱-串联质谱(LC-MS/MS)法、酶放大免疫(EMIT)法检测霉酚酸血药浓度的一致性与差异性。方法:采用荧光免疫层析法、LC-MS/MS法、EMIT法分别检测61份口服吗替麦考酚酯的儿童患者不同时相点血样中的霉酚酸血药浓度,采用Kolmogorov-Smirnov法、Wilcoxon配对检验、Passing-Bablok回归、Cusum法、Spearman相关分析、Bland-Altman散点图等进行统计学分析。结果:荧光免疫层析法、LC-MS/MS法、EMIT法检测的霉酚酸血药浓度结果均呈非正态分布。Passing-Bablok回归分析显示,荧光免疫层析法与LC-MS/MS法、荧光免疫层析法与EMIT法检测结果的回归方程分别为C荧光免疫层析=0.9283CLC-MS/MS+0.9617和C荧光免疫层析=0.8807CEMIT-0.4882,Cusum法检验显示回归偏倚均无统计学意义(P>0.05)。Spearman相关分析显示,荧光免疫层析法与LC-MS/MS法、荧光免疫层析法与EMIT法检测结果的相关系数分别为0.968、0.929(P<0.0001)。Bland-Altman散点图分析显示,荧光免疫层析法与LC-MS/MS法检测结果的差值中有3.28%的差值散点在一致性界限外(±1.96SD),荧光免疫层析法与EMIT法检测结果的差值中有1.64%的差值散点在一致性界限外(±1.96SD)。Wilcoxon配对检验结果显示,荧光免疫层析法检测结果高于LC-MS/MS法检测结果(Z=3.76,P=0.0002)、低于EMIT法检测结果(Z=-5.96,P<0.0001)。结论:荧光免疫层析法与LC-MS/MS法、EMIT法均分别显示出较好的一致性和相关性,荧光免疫层析法所测霉酚酸血药浓度结果高于LC-MS/MS法结果、低于EMIT法结果,可用于床旁快速检测。在根据不同方法检测结果进行临床用药时,需要考虑检测方法的差异性。OBJECTIVE:To investigate the consistency and difference of fluorescence immunochromatographic and liquid chromatography-tandem mass spectrometry(LC-MS/MS)and enzyme multiplied immunoassay technique(EMIT)in the blood concentration monitoring of mycophenolic acid.METHODS:Fluorescence immunochromatography,LC-MS/MS and EMIT were used to detect the blood concentration of mycophenolic acid in 61 blood samples of children treated with mycophenolate mofetil ester orally at different time points.Kolmogorov-Smirnov method,Wilcoxon pairing test,Passing-Bablok regression,Cusum method,Spearman correlation analysis,Bland-Altman scatter diagram were adopted for statistical analysis.RESULTS:Blood concentrations of mycophenolic acid,which were determined by fluorescence immunochromatography,LC-MS/MS and EMIT,showed non-normal distribution.Passing-Bablok regression analysis showed that regression equation of fluorescence immunochromatography and LC-MS/MS,fluorescence immunochromatographic method and EMIT were CFI=0.9283CLC-MS/MS+0.9617 and CFI=0.8807CEMIT-0.4882(FI means fluorescence immunochromatographic).Spearman correlation analysis showed that the correlation coefficients between fluorescence immunochromatography and LC-MS/MS,fluorescence immunochromatography and EMIT were 0.968 and 0.929,respectively(P<0.0001).Bland Altman scatter plot analysis showed that 3.28%of the difference between fluorescence immunochromatography and LC-MS/MS was outside the consistency limit(±1.96SD),and 1.64%of the difference between fluorescence immunochromatography and EMIT was outside the consistency limit(±1.96SD).Wilcoxon pairing test showed that the results of fluorescence immunochromatography were higher than those of LC-MS/MS(Z=3.76,P=0.0002)and lower than those of EMIT(Z=-5.96,P<0.0001).CONCLUSIONS:Fluorescence immunochromatography shows good consistency and correlation with LC-MS/MS and EMIT;the blood concentrations of mycophenolic acid detected by fluorescence immunochromatography were higher than those by LC-MS/MS and lower than those b

关 键 词：霉酚酸 血药浓度 荧光免疫层析法 液相色谱-串联质谱法 酶放大免疫法 

分 类 号：R969.1[医药卫生—药理学] R979.5[医药卫生—药学]