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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(P>0.05)。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。
Objective To compare the correlation between the concentration of tacrolimus (FK506) by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS / MS) and chemiluminescence microparticle immunoassay (CMIA) Monitoring application. Methods A total of 119 whole blood samples of patients with organ transplantation requiring tacrolimus plasma concentration measurement were collected. The HPLC-MS / MS method for the determination of whole blood concentration of tacrolimus was established and confirmed. The HPLC-MS / MS and The tacrolimus concentrations of the same clinical samples were determined by the CMIA method commonly used in therapeutic drug monitoring (TDM). The results of the statistical analysis and comparison, evaluation of two methods to determine the relevance of the results. Results The concentrations of tacrolimus in 119 samples ranged from 1.30 to 28.50 ng · m L -1. The mean concentrations of tacrolimus by HPLC-MS / MS and CMIA were (7.57 ± 5.16) and (7.66 ± 5.22) ng · m L -1, respectively, and the ratio of the two groups was (100.37 ± 16.28)%. The results of the two groups were yHPLC-MS / MS = 0.97xCMIA + 0.16 (r = 0.988 9), the correlation is better. There was no significant difference between the two methods in determining the concentration (P> 0.05). Conclusion The results of HPLC-MS / MS and CMIA for the determination of tacrolimus in human whole blood are in good agreement and are suitable for the routine TDM work of tacrolimus.