McBride J H, Kim S S, Danovitch G M, Rodgerson D O, Reyes A F, Ota M K
Department of Pathology and Laboratory Medicine, UCLA School of Medicine 90024-1732.
Clin Chem. 1993 Jul;39(7):1415-9.
Cyclosporin G (CsG) is less nephrotoxic than cyclosporin A (CsA) and is undergoing clinical trials for use as an immunosuppressive agent after renal transplantation. Three assays for whole-blood CsA-HPLC, RIA (INCSTAR, Cyclo-Trac SP), and FPIA (Abbott TDx)--were adapted for use with CsG and were assessed for analytical suitability and to determine which assay was capable of deriving CsG values rapidly after transplantation. The assays were acceptable in terms of sensitivity, linearity, analytical recovery, and precision. When considering blood samples (n = 107) from renal transplant recipients receiving a low dose of CsG (5 mg/kg per day) and a high dose (10 mg/kg per day), we obtained the following correlation data: RIA = 0.974HPLC + 27.89 (r = 0.9798, Sy/x = 39.24); FPIA = 0.964HPLC + 33.59 (r = 0.9819, Sy/x = 36.66); and FPIA = 0.977RIA + 9.50 (r = 0.9894, Sy/x = 28.12). The FPIA of CsG is recommended as the most rapid method, although it is the most expensive. HPLC, RIA, and FPIA were capable of accurately deriving projected CsG concentrations at various stages of the clinical trial when the low- and high-dose regimes were tapered over a period of 16 weeks.
环孢菌素G(CsG)的肾毒性比环孢菌素A(CsA)小,目前正在进行临床试验,用于肾移植后作为免疫抑制剂。三种全血CsA检测方法——高效液相色谱法(HPLC)、放射免疫分析法(RIA,INCSTAR公司的Cyclo-Trac SP)和荧光偏振免疫分析法(FPIA,雅培公司的TDx)——被调整用于CsG检测,并评估其分析适用性,以确定哪种检测方法能够在移植后快速得出CsG值。这些检测方法在灵敏度、线性、分析回收率和精密度方面都可以接受。在考虑接受低剂量CsG(每天5毫克/千克)和高剂量(每天10毫克/千克)的肾移植受者的血样(n = 107)时,我们获得了以下相关数据:RIA = 0.974HPLC + 27.89(r = 0.9798,Sy/x = 39.24);FPIA = 0.964HPLC + 33.59(r = 0.9819,Sy/x = 36.66);FPIA = 0.977RIA + 9.50(r = 0.9894,Sy/x = 28.12)。虽然FPIA检测CsG的方法是最昂贵的,但被推荐为最快速的方法。当低剂量和高剂量方案在16周内逐渐减少时,HPLC、RIA和FPIA能够在临床试验的各个阶段准确得出预计的CsG浓度。