中国临床药理学杂志2016，Vol.32Issue(7)：640-642,651,4.DOI:10.13699/j.cnki.1001-6821.2016.07.020
液相色谱－质谱法和酶扩大免疫法测定地高辛血药浓度的方法研究
Comparison of liquid chromatography -tandem mass spectrometry and enzyme multiplied immunoassay technique for the determination of plasma concentration of digoxin
摘要
Abstract
Objective To compare liquid chromatography -tandem mass spectrometry ( LC-MS/MS ) and enzyme multiplied immunoassay technique ( EMIT) for the determination of digoxin in human plasma, and to evaluate the differences between two methods.Methods Method validation of LC -MS/MS was performed.A total of 75 samples from patients treated with digoxin were collected in therapeutic drug monitoring room.The results obtained by LC -MS/MS and EMIT were analyzed using paired t test.Results LC-MS/MS validation was consistent with the requirements of methodology.The results of 75 samples determined by two methods showed there was no statistical difference ( P>0.05 ) in low -concentration region.However, EMIT data in middle and high concentration region was significantly higher than that obtained by LC-MS/MS ( P <0.001 ).The mean differences between the two methods were (0.57 ±0.72) ng· mL-1 in middle-concentration region and (2.48 ±2.15 ) ng · mL-1 in high -concentration region, outside the clinically acceptable range.Conclusion Compared with the EMIT, LC-MS/MS is more suitable for clinical determination of the plasma concentrations of digoxin because of less interference of plasma immuno-reactive substances and more accurate quantitation.关键词
地高辛/酶扩大免疫法/LC-MS/MS/治疗药物监测/差异性Key words
digoxin/enzyme multiplied immunoassay technique/LC-MS/MS/therapy drug monitor/difference分类
医药卫生引用本文复制引用
董占军,白万军,刘洪涛,宋浩静,邱志宏,安静,张淑慧..液相色谱－质谱法和酶扩大免疫法测定地高辛血药浓度的方法研究[J].中国临床药理学杂志,2016,32(7):640-642,651,4.基金项目
河北省医学适用技术跟踪基金资助项目（G2015006）；河北省卫计委医学科学研究重点课题基金资助项目 （）
