中文摘要：

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。

英文摘要：

Objective To compare the results of carbamazepine（ CBZ）serum concentrations determined by high performance liquid chromatography（ HPLC） and fluorescence polarization immunoassay（ FPIA） respectively and evaluate the correlation and difference of two methods.Methods Both HPLC and FPIA were used to determine serum concentrations of carbamazepine in 400 epileptic patients. The correlation and difference of CBZ concentrations detected by HPLC and FPIA were respectively evaluated with Deming regression analysis method and Bland-Altman plot. Results There was good correlation between carbamazepine concentrations determined by the two methods. Deming regression equation was CBZ_（FPIA）= 1. 09 × CBZ_（HPLC）＋ 0. 33,and Pearson correlation coefficient was 0. 964 2. The CBZ concentration measured by FPIA was 13. 42% higher than that by HPLC（ 95% confidence interval：-4. 4%-31. 2%）. There were significant differences in the relative errors between four CBZ concentration ranges,and the maximal relative error was in concentration 〈6 μg · m L^-1. Conclusion When CBZ individualized dosage regimen was adjusted according to therapeutic drug monitoring,differences of concentrations caused by different methods as well as the potential metabolites interference should be considered.Concentrations of the metabolites should be determined simultaneously with paren drug as needed.