Garrido Manuel J, Hermida Jesús, Tutor J Carlos
Laboratorio Central, Hospital Clínico Universitario, Santiago de Compostela, Spain.
Ther Drug Monit. 2002 Dec;24(6):785-8. doi: 10.1097/00007691-200212000-00016.
Current evidence suggests that cyclosporine (CsA) concentration in blood samples taken 2 hours after Neoral microemulsion (Novartis Pharmaceuticals; East Hanover, NJ) administration (C2) predicts clinical events in transplant patients better than the pre-dose (trough) concentration (C0). Similarly, previous findings have shown that the metabolites/CsA ratio is substantially lower in C2 than in C0 samples; however the between-monoclonal immunoassay differences for C2 samples have received little attention in the literature. In 56 C samples and 60 C samples from renal transplant patients, CsA levels were determined using the monoclonal fluorescence polarization immunoassay (mFPIA) from Abbott (Abbott Park, IL) and the homogeneous enzyme immunoassay technique (HEIT) from Roche Diagnostics (Basel, Switzerland). In both cases a high correlation coefficient between the results was obtained (r > or = 0.971), with a linear regression for C0 samples: mFPIA = 1.47 HEIT + 22.0 and for C2 samples: mFPIA = 1.11 HEIT + 71.96. The difference between the linear regression slopes was statistically significant (P < 0.001), and the mFPIA/HEIT ratio was significantly higher for C than for C samples (P < 0.001).
目前的证据表明，在服用新山地明微乳剂（诺华制药公司；新泽西州东哈嫩）2小时后采集的血样中环孢素（CsA）浓度（C2）比给药前（谷值）浓度（C0）能更好地预测移植患者的临床事件。同样，先前的研究结果表明，C2样本中代谢物/CsA比值显著低于C0样本；然而，文献中很少关注C2样本在单克隆免疫测定之间的差异。在56份C0样本和60份来自肾移植患者的C2样本中，使用雅培公司（伊利诺伊州雅培公园）的单克隆荧光偏振免疫测定法（mFPIA）和罗氏诊断公司（瑞士巴塞尔）的均相酶免疫测定技术（HEIT）测定CsA水平。在这两种情况下，结果之间均获得了较高的相关系数（r≥0.971），C0样本的线性回归方程为：mFPIA = 1.47 HEIT + 22.0，C2样本的线性回归方程为：mFPIA = 1.11 HEIT + 71.96。线性回归斜率之间的差异具有统计学意义（P < 0.001），且C0样本的mFPIA/HEIT比值显著高于C2样本（P < 0.001）。
