肾移植患者他克莫司血药浓度测定与临床合理用药分析

Determination of the rational clinical use of blood concentration of tacrolimus in patients with renal transplantation

目的：他克莫司（FK506）属钙调神经磷酸酶抑制剂,其免疫抑制作用机制与环孢素相似。目前FK506在临床广泛应用于器官移植和自身免疫系统疾病的免疫抑制治疗[1]。由于FK506的治疗窗窄、不良反应大,而且容易受到其他联合用药的影响,因此,需要监测FK506的血药浓度,以实现个体化用药,确保用药安全、有效。他克莫司浓度监测的主要方法有酶联免疫吸附法（ELISA）、微粒酶免分析法（MEIA）、HPLC法、HPLC/MS法和酶放大免疫分析法（EMIT）法等,目前国内外报道较多的有ELISA法和MEIA法。本文探讨本实验室监测肾移植患者全血中他克莫司药物浓度方法的可靠性,分析影响病人血药浓度的相关因素,为制定合理的个体化给药方案提供参考。方法：采用酶放大免疫（EMIT）法,选取我院数据收集较为齐全的13例肾移植患者为研究对象。结果：实验测得他克莫司的批内精密度RSD分别为14.17%、10.66%、9.18%。批间精密度RSD分别为12.1%、9.92%、10.05%。回收率为98.5%、99.2%、101.3%,在5~30ng/m L范围内线性良好。术后一个月内13个患者FK506血药浓度的平均值在5.52±2.11~13.09±4.21ng/m L。结论：实验表明本实验室采用EMIT法测定血药浓度的精密度、准确性和线性良好。

Objective： Reliability of tacrolimus in human plasma drug concentration in blood of the clinical pharmacy laboratory monitoring in patients with renal transplantation. To analyze the related factors affecting the blood concentration,for making the rational individual regimen provides reference. Analysis： The enzyme amplification immune（ EMIT）,renal transplantation in our hospital from2012 January to 2013 December were selected as research object. Results： To tacrolimus test day RSD were 14. 17%,10. 66%,9. 18%. Daytime RSD were 12. 1%,9. 92%,10. 05%. Recovery of all the concentration rate of 98. 5% 、99. 2% 、101. 3%,5 ~30ng / ml good linearity. One month after the operation in 13 patients with FK506 serum concentration of the average value was 5. 52 ±2. 11,13. 09 ± 4. 21 ng / ml. Conclusion： Experiments show that the precision,accuracy and linearity of the laboratory determination of blood drug concentration by EMIT method is good.