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目的比较高效液相色谱法(HPLC)和荧光免疫偏振法(FPIA)测定的卡马西平(CBZ)血药浓度结果,考察两种方法测定值的相关性和差异性。方法用HPLC法和FPIA法分别测定400例癫痫患者体内卡马西平血清药物浓度,用Deming回归法和Bland-Altman偏差图分析测定值的相关程度和偏差。结果两种方法测定的卡马西平血药浓度值具有良好的相关性,Deming回归方程为_(FPIA)=1.09×CBZ_(HPLC)+0.33,Pearson相关系数为0.964 2。FPIA法测定结果比HPLC法偏高13.42%(95%置信区间:-4.4%~31.2%)。不同卡马西平浓度区间测定偏差存在显著性差异,在低浓度(<6μg·m L~(-1))时偏差最大。结论根据治疗药物监测结果调整卡马西平个体化给药方案时,应考虑不同检测方法以及潜在的代谢物干扰可能引起浓度测定值的差异,必要时需同时检测代谢物的血药浓度。
Objective To compare the plasma concentrations of carbamazepine (CBZ) measured by high performance liquid chromatography (HPLC) and fluorescence immuno-polarimetry (FPIA), and investigate the correlation and differences between the two methods. Methods Serum concentrations of carbamazepine in 400 patients with epilepsy were measured by HPLC and FPIA respectively. Depen’s regression and Bland-Altman deviation charts were used to analyze the correlations and deviations of the measured values. Results The plasma concentrations of carbamazepine determined by the two methods had good correlation. The Deming regression equation was (FPIA) = 1.09 × CBZ_ (HPLC) + 0.33, and the Pearson correlation coefficient was 0.964 2. The results of FPIA assay were 13.42% higher than those of HPLC (95% confidence interval: -4.4% ~ 31.2%). There was a significant difference in the determination of different ranges of carbamazepine concentration, with the largest deviation at low concentration (<6μg · m L -1). Conclusions When adjusting carbamazepine individualized dosing regimen based on therapeutic drug monitoring results, different test methods and potential metabolite interference should be considered in the discrepancy test of concentration. If necessary, the plasma concentration of metabolites should be tested at the same time.