Department of Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita City, Osaka 565-0871, Japan.
J Clin Pharmacol. 2010 Jun;50(6):705-9. doi: 10.1177/0091270009352188. Epub 2010 Jan 23.
Therapeutic drug monitoring is necessary when using tacrolimus (FK) due to the associated side effects. The aim of this study was to compare the chemiluminescent assay (CMIA) system with the previously established Abbott IMx Tacrolimus II microparticle enzyme immunoassay (MEIA) in liver transplant recipients and evaluate its accuracy. Between March and June 2008, all blood samples from the liver transplant recipients at the hospital were tested for FK trough level using 2 different methods, CMIA and MEIA. The posttransplant time, hematocrit, and other clinical parameters during the study period were recorded. FK trough level was analyzed in 398 samples from 57 liver transplant recipients by CMIA and MEIA. The correlation in FK level between the 2 methods was excellent (r(2) = 0.941). However, the FK level was underestimated in MEIA by more than 23% in samples with an FK level of less than 3.5 ng/mL and by 6.8% in those with an FK level between 3.5 and 5 ng/mL. CMIA is superior to MEIA in measuring low FK level, allowing the FK level to be maintained at less than 5 ng/mL in selected liver transplant recipients. The effects of maintaining low levels of FK should be evaluated in liver transplant recipients.
由于与他克莫司（FK）相关的副作用，在使用他克莫司时需要进行治疗药物监测。本研究的目的是比较化学发光测定法（CMIA）系统与先前建立的 Abbott IMx Tacrolimus II 微粒酶免疫测定法（MEIA）在肝移植受者中的应用，并评估其准确性。2008 年 3 月至 6 月期间，医院所有肝移植受者的血样均采用 2 种不同方法（CMIA 和 MEIA）检测 FK 谷浓度。记录研究期间的移植后时间、红细胞压积和其他临床参数。采用 CMIA 和 MEIA 对 57 例肝移植受者的 398 份样本进行 FK 谷浓度分析。两种方法的 FK 水平相关性极好（r²=0.941）。然而，在 FK 水平低于 3.5ng/mL 的样本中，MEIA 法低估 FK 水平超过 23%，在 FK 水平在 3.5 至 5ng/mL 之间的样本中低估 6.8%。CMIA 在测量低 FK 水平方面优于 MEIA，可使选定的肝移植受者的 FK 水平维持在 5ng/mL 以下。应在肝移植受者中评估维持低 FK 水平的效果。
