Luo Xiao-Hui, Xue Wu-Jun, Tian Pu-Xun, Ding Xiao-Ming, Yan Hang, Xiang He-Li, Li Yang
Department of Renal Transplant, Center of Nephropathy, the First Affiliated Hospital, Medical School of Xi'an Jiaotong University, Xi'an 710061, China.
J Pharm Anal. 2011 May;1(2):139-142. doi: 10.1016/S2095-1779(11)70024-7. Epub 2012 Jan 30.
The feasibility and the clinical value of the enzyme-multiplied immunoassay technique (EMIT) monitoring of blood concentrations of cyclosporine A (CsA) in patients treated with CsA were investigated after kidney transplantation. The validation method was performed to the EMIT determination of CsA blood concentration, the CsA whole blood 'trough concentrations (C) of patients in different time periods after renal transplantation were monitored, and combined with the clinical complications, the statistical results were analyzed and compared. EMIT was precise, accurate and stable, also with a high quality control. The mean postoperative blood concentration of CsA was as follows: <1 month, (281.4 ± 57.9)ng/mL; 2 - 3 months, (264.5 ± 41. 2)ng/mL; 4 - 5 months, (236.4 ± 38. 9)ng/mL; 6 - 12 months, (206.5 ± 32.6)ng/mL; >12 months, (185.6 ± 28.1)ng/mL. The toxic reaction rate of CsA blood concentration within the recommended therapeutic concentration was 14. 1%, significantly lower than that of the none-recommended dose group (37.2%) ( < 0.05); the transplantation rejection rate was 4.4%, significantly lower than that of the none-recommended dose group (22.5%) ( < 0.05). Using EMIT to monitor the blood concentration of CsA as the routine laboratory method is feasible, and is able to reduce the CsA toxicity and rejection significantly, leading to achieving the desired therapeutic effect.
研究了酶放大免疫分析技术（EMIT）监测肾移植患者环孢素A（CsA）血药浓度的可行性及临床价值。对EMIT法测定CsA血药浓度进行了方法验证，监测了肾移植患者不同时期的CsA全血谷浓度（C），并结合临床并发症进行统计结果分析比较。EMIT法精确、准确、稳定，且具有较高的质量控制水平。术后CsA血药浓度均值如下：<1个月，（281.4±57.9）ng/mL；2 - 3个月，（264.5±41.2）ng/mL；4 - 5个月，（236.4±38.9）ng/mL；6 - 12个月，（206.5±32.6）ng/mL；>12个月，（185.6±28.1）ng/mL。CsA血药浓度在推荐治疗浓度范围内的毒性反应发生率为14.1%，显著低于非推荐剂量组（37.2%）（<0.05）；移植排斥反应发生率为4.4%，显著低于非推荐剂量组（22.5%）（<0.05）。采用EMIT法监测CsA血药浓度作为常规实验室方法是可行的，能够显著降低CsA毒性及排斥反应，从而达到理想的治疗效果。
