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目的分析环孢霉素A(CSA)和普乐可复(FK506)药物浓度监测(TDM)的室内质控结果。方法采用酶放大免疫分析法(EMIT)测定CSA和FK506血药浓度的高、低质控品,绘制质控图,并对2007年的随行质控结果进行统计学分析。结果 EMIT法测定CSA和FK506的日内RSD分别为5.89%～9.41%、8.34%～9.30%,日内方法回收率分别为92.8%～98.3%、89.1%～89.5%;日间RSD分别为8.51%～9.74%、8.46%～8.78%,方法回收率分别为91.0%～102.7%、89.6%～99.1%。2007年随行质控测定值的RSD为10.02%～14.41%,符合《中国药典》对生物样品的测定要求。结论 EMIT法测定CSA和FK506血药浓度准确、稳定性良好,适于临床开展TDM,临床应用时应建立合理的质控体系。
Objective To analyze the results of laboratory quality control of Cyclosporine A (CSA) and Progam (FK506) drug concentration monitoring (TDM). Methods Enzyme amplification immunoassay (EMIT) was used to determine the high and low quality control products of CSA and FK506 plasma concentrations, and the quality control charts were drawn. The statistical analysis of the quality control results in 2007 was performed. Results The intra-day RSD of CSA and FK506 measured by EMIT method were 5.89% -9.41% and 8.34% -9.30%, respectively. The daily recovery rates were 92.8% -98.3% and 89.1% -89.5%, respectively. The daytime RSD were 8.51% 9.74% and 8.46% ~ 8.78% respectively. The recoveries of the method were 91.0% ~ 102.7% and 89.6% ~ 99.1%, respectively. In 2007, the RSD of the concomitant control measures was 10.02% ~ 14.41%, which was in line with the requirements of the Chinese Pharmacopoeia for the determination of biological samples. Conclusion EMIT method for the determination of CSA and FK506 blood concentration accuracy, good stability, suitable for clinical TDM, clinical application should establish a reasonable quality control system.