高效液相色谱串联质谱法和化学发光微粒子免疫分析法测定人全血中他克莫司浓度的一致性评价

发布时间：2018-08-18 18:15

【摘要】：目的比较高效液相色谱串联质谱(HPLC-MS/MS)法与化学发光微粒子免疫分析法(CMIA)测定他克莫司(FK506)浓度结果的相关性,以及2种方法在他克莫司浓度监测工作中的应用。方法收集119例需测定他克莫司血药浓度的器官移植患者的全血样本,建立测定他克莫司全血浓度的HPLC-MS/MS方法并进行确证,用HPLC-MS/MS法和治疗药物监测(TDM)常用的CMIA法分别测定相同临床样本的他克莫司浓度。对测定结果进行统计分析和比对,评价2种方法测定结果的相关性。结果 119例样本中他克莫司浓度分布范围为1.30~28.50 ng·m L~(-1),HPLC-MS/MS法与CMIA法对他克莫司浓度测定的结果平均值分别为(7.57±5.16)和(7.66±5.22)ng·m L~(-1),2组结果比值为(100.37±16.28)%;2组测定结果方程式为yHPLC-MS/MS=0.97xCMIA+0.16(r=0.988 9),相关性较好。对2种方法测定浓度结果比较差异无统计学意义(P0.05)。结论 HPLC-MS/MS法与CMIA法测定人全血中他克莫司的结果一致性较好,均适用于他克莫司的日常TDM工作。
[Abstract]:Objective to compare the correlation between high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) and chemiluminescence microparticle immunoassay (CMIA) for the determination of tacrolimus (FK506) concentration. Methods the whole blood samples were collected from 119 organ transplant patients whose blood concentration was determined by tacrolimus. A HPLC-MS/MS method was established to determine the whole blood concentration of tacrolimus. Tacrolimus concentrations in the same clinical samples were determined by HPLC-MS/MS method and CMIA method commonly used to monitor (TDM). The correlation between the two methods was evaluated by statistical analysis and comparison. Results the concentration distribution range of tacrolimus was 1.30 ~ 28.50 ng / mL ~ (-1) and the average value of CMIA and HPLC-MS for tacrolimus were (7.57 卤5.16) and (7.66 卤5.22) ng m / L ~ (-1), respectively. The ratio of results in two groups was (100.37 卤16.28) ng / ml ~ (-1). The result equation was yHPLC-MS/MS=0.97xCMIA 0.16 (r = 0.988 9). There was no significant difference between the two methods (P0.05). Conclusion the results of HPLC-MS/MS method and CMIA method for the determination of tacrolimus in human whole blood are consistent and suitable for the daily TDM work of tacrolimus.
【作者单位】：首都医科大学附属北京朝阳医院药事部;
【基金】：北京市金桥工程种子基金资助项目(2014-46-C)
【分类号】：R969

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