环孢素A和他克莫司血药浓度监测的质控评价与分析

目的:评价荧光偏振免疫分析法测定环孢素A(CsA)以及微粒子酶免分析(MEIA)法测定他克莫司(FK506)血药浓度过程中质控的稳定性。方法:对2007年6～8月我院作CsA和FK506血药浓度监测患者血样的质控结果进行连续性评价与分析,考察其稳定性和准确性。结果:CsA和FK506低、中、高3种浓度质控的平均相对回收率分别为93.14%～97.65%、97.70%～103.09%,RSD分别为4.41%～5.37%、10.44%～14.23%,符合《中国药典》生物样品监测规定。结论:荧光偏振免疫分析法测定CsA和MEIA法测定FK506血药浓度的方法较为准确,值得在临床应用并指导个体化给药。

Assessment and Analysis of Quality Control for Therapeutic Drug Monitoring of Cyelosporine A and Tacrolimus

OBJECTIVE： To assess the stability of the quality control of FPIA for monitoring of CsA and MEIA for monitoring of FK506. METHODS： The quality control on the blood samples of patients receiving therapeutic drug monitoring of CsA and FK506 from June to August in 2007 were subjected to a continual assessment and analysis to investigate the stability and accuracy of the quality control. RESULTS： The mean recoveries of the low, middle and high concentrations of CsA and FK506 were 93.14%-97.65% and 97.70%- 103.09% respectively, with RSD at 4.41%-5.37% and 10.44%-14.23% respectively, which accorded with the requirement for biological sample determination stated in the Chinese Pharmacopoeia. CONCLUSION ： The methods of FPIA for monitoring of CsA and MEIA for monitoring of FK506 were accurate, and worth to be applied in clinical to guide individualized medication.