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目的:用HPLC法测定癫痫患者血浆中丙戊酸的浓度,与化学发光微粒子免疫法(CMIA)比较,评价两种测定方法的一致性。方法:分别用HPLC法和CMIA法测定230例癫痫患者血浆中丙戊酸的浓度,测定值用Passing-Bablok回归法和Bland-Altman法分析,考察2种方法的相关性及差异。结果:HPLC法(Y)和CMIA(X)法的回归方程为Y=1.069 7 X+2.338 2(R~2=0.969,n=230),显示两种方法相关性良好;Bland-Altman法分析表明两种测定方法的一致性欠佳,HPLC法测定值偏高。结论:HPLC法和CMIA法测定癫痫患者血浆中丙戊酸的浓度具有较好的相关性,但一致性欠佳,且存在系统误差,在临床治疗中,两种方法不可以互换,应注意调整和选择。
OBJECTIVE: To determine plasma valproic acid concentration in patients with epilepsy by HPLC and to compare the consistency of the two methods with chemiluminescence microparticle immunoassay (CMIA). Methods: The plasma concentrations of valproic acid in 230 patients with epilepsy were measured by HPLC and CMIA respectively. The correlations and differences between the two methods were analyzed by Passing-Bablok regression and Bland-Altman analysis. Results: The regression equation of HPLC (Y) and CMIA (X) was Y = 1.069 7 X + 2.338 2 (R ~ 2 = 0.969, n = 230), which showed that the correlation between the two methods was good. The consistency of the two methods was poor, and the HPLC method showed a high value. CONCLUSION: HPLC and CMIA have a good correlation with plasma valproic acid concentrations in patients with epilepsy, but their consistency is not good and there are systematic errors. In the clinical treatment, the two methods are not interchangeable and should be noticed Adjust and choose.