地高辛血药质量浓度测定在个体化给药中的指导意义  

The guidance value of serum digoxin concentration assay in individualized drug delivery

作　　者：朱敏[1] 周静 ZHU Min;ZHOU Jing(Department of Clinical Pharmacy,Taizhou People′s Hospital,Taizhou 225300,China;Taicang Hospital Affiliated to Suzhou University,Department of Cardiology,Taicang First People′s Hospital,Taicang 215400,China)

机构地区：[1]泰州市人民医院临床药学科,泰州225300 [2]苏州大学附属太仓医院太仓市第一人民医院心内科,太仓215400

出　　处：《西北药学杂志》2019年第2期257-260,共4页Northwest Pharmaceutical Journal

摘　　要：目的比较分析LC-MS/MS和MEIA检测患者地高辛血药质量浓度,为地高辛个体化给药提供指导。方法分别采用LC-MS/MS和MEIA法,检测122例服用地高辛患者的血药质量浓度,验证LC-MS/MS法的准确度、精密度以及定量下限,计算其回归曲线、基质效应指标和提取回收率,考察样本在检测期间的稳定性;同时比较2种方法对质控样本和血浆样本的检测结果。结果采用LC-MS/MS法测定地高辛血药质量浓度,地高辛血药质量浓度在0.05～10.0 ng·mL^(-1)范围内,准确度高,定量限低。样品稳定。与MEIA法比较,LC-MS/MS法虽有较高的准确性,但无显著性差异(P>0.05),而MEIA法与LC-MS/MS法的结果有显著性差异(P<0.05)。结论 LC-MS/MS法是一种较优的地高辛血药质量浓度检测方法,其准确度、精密度均较高,误差范围小,能为临床地高辛的有效使用提供参考依据,促进合理的个体化治疗。Objective To compare the concentration of serum digoxin in patients with LC-MS/MS and MEIA to provide guidance for the individualized drug delivery.Methods 122 cases treated with digoxin were analyzed by LC-MS/MS and MEIA method,respectively,with detecting the blood drug concentration.The LC-MS/MS method was validated in terms of quantitative limit,accuracy,linear relationship,matrix effect,recovery rate of extraction,and sample stability.Results The concentration of serum digoxin was detected by LC-MS/MS with good accuracy,high precision,and low quantitative limit in the range of 0.05 to 10.0 ng·mL^-1 .The samples were stable.Compared with the MEIA method,although the quality control samples′ test proved that the LC-MS/MS was more accurate,but there was no significant difference ( P >0.05),while there was significant difference between the real concentration and the results of MEIA ( P <0.05).Conclusion LC-MS/MS is a better serum digoxin concentration detection method with high accuracy and precision,which could provide the guidance for clinical effective use of digoxin.

关 键 词：地高辛 血药质量浓度 个体化给药 LC-MS/MS MEIA 

分 类 号：R972[医药卫生—药品]