CAJ | 학술논문

背景：不同免疫法测定的他克莫司血药浓度，对免疫抑制作用及毒性反应的预测能力是否有差异，在肾功能异常时是否能够更加敏感的反映患者血药浓度，是值得研究的问题。 　　目的：联合肾功能指标，分析酶联免疫吸附技术和酶增强免疫技术测定他克莫司血药浓度的相关性。 　　方法：收集133例应用他克莫司治疗的肾移植患者血样，分别用酶联免疫吸附技术、酶增强免疫技术测定血药浓度。分析两种方法测定的相同浓度范围内肾功能异常的发生率；分析不同浓度范围内，两种方法测定结果的相关性。 　　结果与结论：在肾功能异常时，比较两种方法测定的浓度，酶联免疫吸附法测定结果均值较高，且波动较大。酶联免疫吸附法测定他克莫司血药浓度5-20μg/L范围内，肾功能异常发生率较酶增强免疫法少，分析显示两种方法测定结果总体差异无显著性意义(r=0.9045，P>0.05)。以酶联免疫吸附法为标准，在他克莫司血药浓度<2.0μg/L时，酶增强免疫法测定结果明显较高(P<0.01)。在血药浓度为≥2.0μg/L时，两种方法测定结果差异无显著性意义(P>0.05)。说明酶增强免疫法与酶联免疫吸附法相关性较好，均适合于临床常规测定他克莫司的血药浓度，建议结合肾功能指标，细化区分两种测定方法的参考范围。同时，在患者血药浓度极低(<2.0μg/L)时，不建议采用酶增强免疫法。
배경：불동면역법측정적타극막사혈약농도，대면역억제작용급독성반응적예측능력시부유차이，재신공능이상시시부능구경가민감적반영환자혈약농도，시치득연구적문제。 　　목적：연합신공능지표，분석매련면역흡부기술화매증강면역기술측정타극막사혈약농도적상관성。 　　방법：수집133례응용타극막사치료적신이식환자혈양，분별용매련면역흡부기술、매증강면역기술측정혈약농도。분석량충방법측정적상동농도범위내신공능이상적발생솔；분석불동농도범위내，량충방법측정결과적상관성。 　　결과여결론：재신공능이상시，비교량충방법측정적농도，매련면역흡부법측정결과균치교고，차파동교대。매련면역흡부법측정타극막사혈약농도5-20μg/L범위내，신공능이상발생솔교매증강면역법소，분석현시량충방법측정결과총체차이무현저성의의(r=0.9045，P>0.05)。이매련면역흡부법위표준，재타극막사혈약농도<2.0μg/L시，매증강면역법측정결과명현교고(P<0.01)。재혈약농도위≥2.0μg/L시，량충방법측정결과차이무현저성의의(P>0.05)。설명매증강면역법여매련면역흡부법상관성교호，균괄합우림상상규측정타극막사적혈약농도，건의결합신공능지표，세화구분량충측정방법적삼고범위。동시，재환자혈약농도겁저(<2.0μg/L)시，불건의채용매증강면역법。
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 col ected. 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 5-20μg/L by ELISA, the incidence of renal dysfunction occurred less than by EMIT. The overal 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 2.0μg/L, the concentration results by EMIT were higher than those by ELISA (P<0.01). When the concentration was more than 2.0μg/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 (<2.0μg/L). The reference range of concentration should be compartmentalized depending on combination of determination methods and renal function.