Page 79 - 《中国药房》2021年23期

·药物与临床·

3种方法检测霉酚酸血药浓度的一致性与差异性比较 Δ

吕凤俊 ，李 思 ，孙凤军 ，樊继山 （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
2
1＊
1
1 #
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）

中图分类号 R969.1；R979.5 文献标志码 A 文章编号 1001-0408（2021）23-2885-05
DOI 10.6039/j.issn.1001-0408.2021.23.12

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＝
0.928 3CLC-MS/MS+0.961 7 和 C 荧光免疫层析＝0.880 7CEMIT－0.488 2，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＜
0.000 1）。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＝0.000 2）、低于EMIT法检测结果（Z＝－5.96，
P＜0.000 1）。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。
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

Comparison of the Consistency and Difference of Three Detection Methods in Blood Concentration
Monitoring of Mycophenolic Acid
LYU Fengjun ，LI Si ，SUN Fengjun ，FAN Jishan（1. Dept. of Pharmacy，Children’s Hospital of Chongqing
1
1
1
2
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；2. Dept. of Pharmacy，the First Affiliated Hospital of Army Medical University，Chongqing 400038，
China）

ABSTRACT 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 C FI=0.928 3C LC-MS/MS+0.961 7
and C FI＝0.880 7CEMIT －0.488 2（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＜0.000 1）.
Δ 基金项目：重庆市科卫联合医学科研项目（No.2020MSXM069）
Bland Altman scatter plot analysis showed that 3.28％ of the
＊药师。研究方向：临床药学。电话：023-63630481。E-mail：
358341451@qq.com difference between fluorescence immunochromatography and
# 通信作者：副主任药师，博士。研究方向：临床药学。电话： LC-MS/MS was outside the consistency limit （± 1.96SD），
023-63630481。E-mail：400926@hospital.cqmu.edu.cn and 1.64％ of the difference between fluorescence immuno-

中国药房 2021年第32卷第23期 China Pharmacy 2021 Vol. 32 No. 23 ·2885 ·