FPIA法与HPLC法监测癫痫患儿外周血丙戊酸钠浓度差异的比较

A comparative study of Sodium valproate concentration in peripheral blood monitoring by FPIA and HPLC in epilepsy children

目的 探讨比较荧光偏振免疫分析法（FPIA）与高效液相色谱法（HPLC）监测癫痫患儿外周血丙戊酸钠浓度的差异。方法 选取2014年2月~2016年6月浙江舟山医院服用丙戊酸钠治疗的癫痫患儿87例,于末次用药后次日清晨采集患者空腹肘静脉血,分别采用FPIA法和HPLC法检测对血清样本丙戊酸钠浓度进行检测,观察、比较2种检测手段的测定结果、相关性及一致性。结果 FPIA法检测患儿外周血丙戊酸钠的日内及日间RSD均〈5%,回收率90%~110%,精密度及准确度较高;HPLC法检测患儿外周血丙戊酸钠的日内及日间RSD均〈5%,回收率90%~110%之间,精密度及准确度较高;以HPLC法测定值（X）与FPIA法测定值（Y）所作线性回归方程为：Y=0.8355X＋1.8231,相关系数r=0.914,2种检测结果呈正相关关系;采用FPIA法测得的丙戊酸钠血药浓度明显低于HPLC法测得的丙戊酸钠血药浓度,差异具有统计学意义（P〈0.05）;Bland-Altman偏差图结果显示,HPLC法测定血药浓度比FPIA法高7.2μg/m L。结论 FPIA法与HPLC法监测癫痫患儿外周血丙戊酸钠浓度的精密度及准确度均较高,且相关性较好,但2种方法的检测结果具有明显差异,HPLC法检测结果高于FPIA法,需根据临床情况选择判断。

Objective To investigate the comparation of sodium valproate concentration in peripheral blood monitoring by fluorescence polarization immunoassay method （FPIA） and high performance liquid chromatography method （HPLC） in epilepsy children.Methods 87 cases of epilepsy children received Sodium valproate treatment in our hospital from February 2014 to June 2016 were selected,fasting venous blood of elbow vein were collected the next morning after last medication, blood concentrations of Sodium valproate in serum samples were detected by FPIA method and HPLC method respectively,the correlation and consistency of results of the two methods were observed and compared-Results The intra day and inter day RSD of Sodium valproate concentration in peripheral blood in epilepsy children detected by FPIA were 〈5%,the recovery rate was 90%-110%,the precision and accuracy were high;The intra day and inter day RSD of Sodium valproate concentration in peripheral blood in epilepsy children detected by HPLC were 〈 5%,the recovery rate was 90%-110%,the precision and accuracy were high; the linear regression equation between determination value of HPLC method （X） and determination value of FPIA method （Y） wasY=0.8355X＋l.8231,correlation coefficient f=0.914,the detection results were positively related;the Sodium valproate blood concentration detected by FPIA was significantly lower than that detected by HPLC method, the difference was statistically significant （P〈0.05）;Bland-Altman deviation chart results show that determination of blood drug concentration by HPLC method was higher than that of FPIA method by 7.2ng/mL.co nclusion The precision and accuracy of sodium valproate concentration in peripheral blood monitoring by FPIA method and HPLC method were all high, and the correlation was good, but the detection results of the two methods were significantly different,the detection result of HPLC method was higher than that of FPIA method,need to choose and judge according to the clinical situation.