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目的比较液相色谱-质谱法(LC-MS/MS)和酶扩大免疫法(EMIT)监测地高辛血药浓度的差异性。方法建立LC-MS/MS测定地高辛血药浓度的方法学。收集我院治疗药物监测室监测地高辛血浆标本75例,分别用LC-MS/MS和EMIT法进行测定,结果进行配对t检验。结果 LC-MS/MS测定地高辛血药浓度符合方法学要求。低质量浓度区域LC-MS/MS法与EMIT法差异无统计学意义(P>0.05);中、高质量浓度区域EMIT法测定结果显著高于LC-MS/MS法(P<0.001)。中质量浓度区域2种方法的平均差值为(0.57±0.72)ng·mL~(-1);高质量浓度区域的平均差值为(2.48±2.15)ng·mL~(-1),明显超出临床可接受范围。结论相比较于EMIT法,LC-MS/MS法能够排除血浆中免疫活性物质的干扰,实现地高辛血药浓度的准确定量。
Objective To compare the differences of plasma concentrations of digoxin between liquid chromatography-mass spectrometry (LC-MS / MS) and enzyme immunoassay (EMIT). Methods To establish a method for the determination of digoxin plasma concentration by LC-MS / MS. Seventy-five plasma samples of digoxin were collected from the treatment drug monitoring room of our hospital. The results were analyzed by LC-MS / MS and EMIT respectively. The results were analyzed by paired t-test. Results LC-MS / MS determination of digoxin plasma concentration in line with the methodological requirements. There was no significant difference between LC-MS / MS method and EMIT method in low-quality concentration area (P> 0.05). The results of EMIT method in middle and high quality concentration area were significantly higher than those in LC-MS / MS method (P <0.001). (0.57 ± 0.72) ng · mL -1 in the medium concentration area, and 2.48 ± 2.15 ng · mL -1 in the high quality concentration area Beyond the clinically acceptable range. Conclusion Compared with the EMIT method, the LC-MS / MS method can eliminate the interference of the immunologically active substances in plasma and achieve accurate quantification of digoxin plasma concentration.