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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。
OBJECTIVE: To analyze the correlation between the concentration of valproic acid (VPA) in human plasma by enzyme-linked immunosorbent assay (EMIT) and high performance liquid chromatography (HPLC), and provide a reference for clinical monitoring of plasma concentration of valproic acid and individualized medication . Methods The concentrations of valproic acid in 109 blood samples were simultaneously determined by EMIT and HPLC. The differences between the two groups were compared using the two-sided paired t-test, and the scatter plot and Bland-Altman deviation map were drawn. The correlation between the two results was examined Sex. Results The linear regression equation of the results of HPLC (X_1) and the results of EMIT (Y_1) was as follows: Y_1 = 1.016 6X_1 + 3.082 7 (r_1 = 0.942, n = 109) (P = 0.024). When the sample concentration was> 100 mg · L -1, the difference between the two groups was significant No significant (P = 0.596). The deviation curve of Bland-Altman showed that the plasma concentration of valproate in EMIT method was higher than that of HPLC method. Conclusions There is a high correlation between HPLC and EMIT in the determination of valproic acid in human plasma. However, systematic bias may exist. The concentration of valproic acid should be monitored and adjusted accordingly.