Comparative analysis of tacrolimus blood concentrations by two determination methods based on renal function

doi:10.3969/j.issn.2095-4344.2014.05.014

Abstract

Abstract:

BACKGROUND: Whether determination of tacrolimus blood concentration by different immunoassay methods can influence predictive ability to immunosuppressive effects and toxicity, and whether it can be more sensitive to reflect blood concentration in patients with renal dysfunction are worthy of studying.

OBJECTIVE: To analyze the correlation of tacrolimus (FK506) concentrations determined by enzyme-multiplied immunoassay technique (EMIT) and enzyme linked immunosorbent assay (ELISA) in combination with renal function parameters.

METHODS: 133 clinical blood samples were collected. EMIT and ELISA techniques were used to determine the FK506 concentration. The correlation of two determination methods were analyzed, combined with renal function.

RESULTS AND CONCLUSION: In patients with renal dysfunction, the mean results and standard deviation mensurated by ELISA were higher than those by EMIT. For blood concentration in 5-20 μg/L by ELISA, the incidence of renal dysfunction occurred less than by EMIT. The overall mean results of blood concentration for two methods appeared no significant difference (r=0.904 5, P > 0.05). When the concentration was less than

2.0 μg/L, the concentration results by EMIT were higher than those by ELISA (P < 0.01). When the concentration was more than 2.0 μg/L, there was no significant difference between two determination methods (P > 0.05). These findings indicate that EMIT and ELISA has good correlation, which are both suitable for clinical routine determination of plasma concentration. It is not recommended for applying EMIT method to determine low blood concentrations (< 2.0 μg/L). The reference range of concentration should be compartmentalized depending on combination of determination methods and renal function.

中国组织工程研究杂志出版内容重点：肾移植；肝移植；移植；心脏移植；组织移植；皮肤移植；皮瓣移植；血管移植；器官移植；组织工程

全文链接：

Key words: kidney transplantation, tacrolimus, enzyme-linked immunosorbent assay

CLC Number:

R318

Li Xiang, Yan Ming, Shi Guo-bing, Xia Dong-ya, Ren Tian-shu. Comparative analysis of tacrolimus blood concentrations by two determination methods based on renal function[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(5): 736-741.

Figures/Tables 3

2.1 参与者数量分析实验纳入患者133例，均接受测试，全部进入结果分析。 2.2 患者肾功能指标及他克莫司全血浓度测定结果正常参考范围血尿素氮为2.5-8.1 mmol/L，血清肌酐为42- 133 μmol/L，胱抑素为0-1.03 mg/L。他克莫司全血浓度：5-20 μg/L。 2.3 比较肾功能正常及异常时两种方法测定的他克莫司血药浓度结果结果显示，肾功能指标异常组的他克莫司血药浓度均较正常组高，个体差异也明显增大，酶联免疫吸附法测定结果尤为明显。相同肾功能水平，比较两种浓度测定方法，酶联免疫吸附法测定的数据个体差异均大于酶增强免疫法，且数据较酶增强免疫法高，两种方法测定结果差异不具有显著性(表1-3)。由表1可见，结合肌酐水平，比较两种测定方法，血肌酐正常水平下，酶增强免疫法测定的患者浓度较酶联免疫法的范围更窄。酶增强免疫法测定的数据与目前临床用药安全范围(5-20 μg/L)更接近。同时，无论肌酐水平正常或异常，酶联免疫法更能体现患者药物浓度的个体差异。由表2可见，结合尿素氮水平，比较两种测定方法，血尿素氮正常水平下，酶增强免疫法测定的患者浓度较酶联免疫法浓度范围宽，酶增强免疫法测定的浓度数据较酶联免疫法的数据高。但尿素氮异常时，酶联免疫吸附法测定的浓度数据较高。同时，酶增强免疫法测定的数据与目前临床用药安全范围(5-20 μg/L)更接近。无论尿素水平正常或异常，酶联免疫法更能体现患者药物浓度的个体差异。由表3可见，结合胱抑素水平，比较两种测定方法，血胱抑素水平正常时，酶增强免疫法测定的患者浓度较酶联免疫法浓度范围窄，且浓度范围较血清肌酐、尿素氮正常时的范围更小。酶增强免疫法测定的浓度数据较酶联免疫法的数据低。同时，浓度数据的范围表明，酶增强免疫法测定的数据与目前临床用药安全范围(5- 20 μg/L)更接近。但是，酶联免疫法测定的数据更能体现患者药物浓度的个体差异。"

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