酶放大免疫分析法与高效液相色谱法检测人血浆中丙戊酸浓度比较

目的分析评价酶放大免疫分析法(EMIT)和高效液相色谱法(HPLC)测定人血浆中丙戊酸(VPA)浓度的相关性,为临床监测丙戊酸血药浓度及个体化用药提供参考。方法采用EMIT法和HPLC法同时测定109份血样中丙戊酸的浓度,对测定结果采用双侧配对t检验比较差异,并绘制散点图和Bland-Altman偏差图,考察两种测定结果的相关性。结果以HPLC法测定结果(X_1)与EMIT法测定结果(Y_1)作线性回归方程如下:Y_1=1.016 6X_1+3.082 7(r_1=0.942,n=109),2种检测方法测定丙戊酸血药浓度相关性良好,当样本浓度<100 mg·L~(-1)时,两者差异有显著意义(P=0.024):当样本浓度>100 mg·L~(-1)时,两者差异无显著意义(P=0.596)。Bland-Altman偏差图显示EMIT法测血浆中丙戊酸的浓度较HPLC法偏高。结论 HPLC法和EMIT法测定人血浆中丙戊酸的浓度具有较高的相关性,但均可能存在系统偏差,临床监测丙戊酸的浓度时应予以关注并作相应调整。

Comparison of EMIT and HPLC method in monitoring concentration of valproic acid in epileptic patients plasma

AIM To compare the correlation of enzyme-multiplied immunoassay technique(EMIT) and high performance liquid chromatography(HPLC) in monitoring the concentration of valproic acid(VPA) in epileptic patients plasma,and provide a reference for clinical monitoring of blood concentration of valproic acid and individualized drugs administration.METHODS Both EMIT and HPLC were applied to determine the concentration of VPA from 109 epileptic patients.The difference of results was analyzed by the two-sided paired i-test,and draw a scatter plot and Bland-Altman plot.RESULTS The regression equation of results determined by HPLC(X_1) and EMIT(Y_1) was Y_1=1.016 6X_1+3.082 7(r_1 = 0.942,n = 109).When the sample concentration < 100 mg?L~(-1),the differences are significant(P = 0.024).When the sample concentration > 100 mg?L~(-1),there was no significant difference(P = 0.596).The Bland - Altman plot showed that the concentration of VPA determined by EMIT were higher than that by HPLC.CONCLUSION The results determined by EMIT and HPLC methods have high correlation.But the two detection systems possibly have system deviation.We should pay attention to the difference and make some adjustment.