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单克隆荧光偏振免疫分析法检测同期胰肾联合移植受者环孢素的特异性

The specificity of monoclonal fluorescence polarization immunoassay for cyclosporine in recipients of simultaneous pancreas-kidney transplants.

作者信息

Kaplan B, Wang Z, Keilani T, Kaufman D B

机构信息

Division of Nephrology and Transplantation, Northwestern University Medical School, Chicago, Illinois 60611, USA.

出版信息

Ther Drug Monit. 1995 Oct;17(5):499-503. doi: 10.1097/00007691-199510000-00010.

DOI:10.1097/00007691-199510000-00010
PMID:8585113
Abstract

Simultaneous kidney-pancreas transplant (SPK) recipients have a higher rate of acute organ rejection than do recipients of a kidney-alone transplant. The etiology of this increased number of rejection episodes is unknown. Cyclosporine (CsA) monitoring in SPK recipients is an important tool in the care of these patients. Many centers use the monoclonal fluorescence polarization immunoassay (mFPIA) to monitor CsA levels in this group of organ recipients. The reported specificity of the mFPIA for the CsA parent compound has varied in several studies but has not been systematically studied in recipients of an SPK transplant. Twelve recipients of an SPK transplant from 1 month to 3 months after surgery had serial simultaneous whole blood high-performance liquid chromatography (HPLC) and mFPIA CsA concentrations evaluated. A control group of 15 nondiabetic kidney-alone recipients underwent a similar evaluation. The average mFPIA/HPLC ratio in recipients of an SPK was 1.71 +/- 0.05 (r = 0.94), whereas it was 1.56 +/- 0.03 (r = 0.98) in the kidney-alone group (p > 0.01). Interpatient variability (range, 1.41 to 2.13) was very high in the SPK group, whereas intrapatient variability was lower. Seven patients had AUC profiles. The average AUC mFPIA/HPLC ratio was not significantly different from each patient's respective trough ratios. Our study suggests that the mFPIA overestimates CsA parent compound to a greater extent in SPK recipients than in kidney-alone recipients. In addition, the large interpatient variability in the specificity of the mFPIA makes assessing individual patient's levels problematic.

摘要

同时进行肾胰联合移植(SPK)的受者发生急性器官排斥反应的几率高于单纯肾移植受者。排斥反应发作次数增加的病因尚不清楚。对SPK受者进行环孢素(CsA)监测是护理这些患者的一项重要手段。许多中心使用单克隆荧光偏振免疫测定法(mFPIA)来监测这组器官移植受者的CsA水平。在几项研究中,mFPIA对CsA母体化合物的报道特异性有所不同,但尚未在SPK移植受者中进行系统研究。对12例术后1至3个月的SPK移植受者进行了连续的全血高效液相色谱法(HPLC)和mFPIA CsA浓度同步评估。15例非糖尿病单纯肾移植受者组成的对照组进行了类似评估。SPK受者的平均mFPIA/HPLC比值为1.71±0.05(r = 0.94),而单纯肾移植组为1.56±0.03(r = 0.98)(p>0.01)。SPK组患者间变异性(范围为1.41至2.13)非常高,而患者内变异性较低。7例患者有AUC曲线。平均AUC mFPIA/HPLC比值与每位患者各自的谷值比值无显著差异。我们的研究表明,与单纯肾移植受者相比,mFPIA在SPK受者中对CsA母体化合物的高估程度更大。此外,mFPIA特异性的患者间差异很大,使得评估个体患者的水平存在问题。

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