比较HPLC和FPIA法测定人血清中卡马西平的血药浓度

Comparison of HPLC and FPIA method in determination of carbamazepine in human serum

目的比较治疗药物监测中高效液相色谱法(HPLC)和荧光偏振免疫法(FPIA)测定血清中卡马西平(CBZ)的浓度.方法收集上海华山医院和北京天坛医院服用CBZ的癫痫患者608例的稳态谷浓度血样,分别用HPLC法和FPIA法进行测定,用回归法和图解法考察2种测定方法的相关程度以及环氧化卡马西平(CBZE)的交叉反应率.结果CBZE能干扰CBZ的测定,CBZ测定值FPIA较HPLC法高4.58%(95%置信区间:-5.7%～17.6%).CBZE的交叉反应率随CBZE浓度增加而减小.结论在CBZ治疗药物监测中,对不同测定方法测定差异,应予以关注并作相应调整.

Objective To compare high performance liquid chromatography (HPLC)and fluorescence polarization immunoassay (FPIA) method in determination ofcarbamazepine (CBZ) in human serum during routine therapeutic drug monitoring.Method Six hundreds eighty one serum samples were collected from 608 patientsin Shanghai Huashan Hospital and Beijing Tiantan Hospital. Both HPLC and FPIAmethod were employed to determine the concentration of carbamazepine. The resultswere analyzed by regression and graphical method in order to obtain the correlationof the two methods and the cross-reaction of carbamazepine-10,11-epoxide(CBZE). Results The determination of CBZ by FPIA is higher than HPLC about 4.58%(95% confidence interval: -5.7%~17.6%) due to the cross-reactivity ofCBZE, which decreased with increasing CBZE concentration. Conclusion It shouldbe paid attention to the difference of CBZ determination by HPLC and FPIA methodsduring routine clinical pharmacotherapy.