HPLC-MS/MS法和EMIT法分析人血浆中霉酚酸浓度的相关性  

Correlation analysis between HPLC-MS/MS method and EMIT method for the determination of mycophenolic acid in human plasma

作　　者：石友权 冯湘玲 丁玉峰 王康 郑恒[1] SHI You-quan;FENG Xiang-ling;DING Yu-feng;WANG Kang;ZHENG Heng(Department of Pharmacy,Tongji Hospital Affiliated with Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430030,China;Institute of Organ Transplantation,Tongji Hospital Affiliated with Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030 [2]华中科技大学同济医学院附属同济医院器官移植研究所,湖北武汉430030

出　　处：《中国医院药学杂志》2022年第14期1405-1409,1414,共6页Chinese Journal of Hospital Pharmacy

基　　金：国家科技重大专项课题(编号:2017ZX09101001)。

摘　　要：目的:建立高效液相色谱串联质谱法(HPLC-MS/MS)测定人血浆中霉酚酸的浓度,并与酶放大免疫分析法(EMIT)测定的结果进行对比。方法:经霉酚酸治疗的患者血浆样本共111份,以EMIT法进行常规监测后再用HPLC-MS/MS法复测,采用Kolmogorov-Smirnova检验、配对t检验、Pearson相关分析、Passing-Bablok回归法和Bland-Altman一致性限度图研究2种方法测定结果的相关性和一致性,并进行经济学分析。结果:EMIT法和HPLC-MS/MS法测定霉酚酸血浆药物浓度结果的差异有统计学意义,EMIT法检测值(C_(EMIT))比HPLC-MS/MS法检测值(C_(HPLC-MS/MS))高(27.28±28.62)%,Passing-Bablok回归方程为C_(HPLC-MS/MS)=0.931×C_(EMIT )-0.367,r=0.988。此外,HPLC-MS/MS法检测单个样本的成本比EMIT法低35.4元。结论:该研究建立的HPLC-MS/MS法与EMIT法具有较好的相关性,与EMIT法相比,HPLC-MS/MS法成本低,减轻了患者的经济负担,可替代EMIT法用于霉酚酸的常规监测。OBJECTIVE A method for the determination of mycophenolic acid in human plasma by high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS) was established and compared with that of enzyme multiplied immunoassay technique(EMIT).METHODS A total of 111 plasma samples from patients treated with mycophenolic acid were routinely monitored by EMIT method and then retested by HPLC-MS/MS method.Kolmogorov-Smirnova test,paired t test,Pearson correlation analysis,Passing-Bablok regression and Bland-Altman consistency limit diagram were used to study the correlation and consistency of determination results of two methods,and the economic analysis was performed.RESULTS The difference of plasma concentration of mycophenolic acid determined by EMIT method and HPLC-MS/MS method was statistically significant.The value of EMIT method(C_(EMIT)) was(27.28±28.62)% higher than that of HPLC-MS/MS method(C_(HPLC-MS/MS)).Passing-Bablok regression equation was C_(HPLC-MS/MS)=0.931×C_(EMIT )-0.367,r=0.988.In addition,the testing cost of the HPLC-MS/MS method for each sample was 35.4 yuan lower than that of the EMIT method.CONCLUSION The established HPLC-MS/MS method has good correlation with EMIT method.Compared with EMIT method,HPLC-MS/MS method has low cost,and lightens the economic burden of patients and can be used for routine monitoring of mycophenolic acid instead of EMIT method.

关 键 词：霉酚酸 高效液相色谱串联质谱法 酶放大免疫分析法 经济学分析 

分 类 号：R969.1[医药卫生—药理学]