高效液相色谱法、荧光偏振免疫分析法和质谱法监测丙戊酸血药浓度的比较

Comparison of high performance liquid chromatography,fluorescence polarization immunoassay and mass spectrometer method in determination of valproic acid in serum

目的比较高效液相色谱法（HPLC）、荧光偏振免疫分析法（FPIA）和质谱法（HPLC-MS）监测丙戊酸血药浓度的相关性。方法收集规律服用丙戊酸制剂达稳态后的血清样本207例,分别用3种方法进行测定,考察3种测定方法的相关性和差异性。结果 3种测定方法的相关性良好,但总体水平上HPLC法与FPIA法测定结果相比较差异有统计学意义。FPIA法测定丙戊酸血药浓度较HPLC法高0.7μg·m L-1（95%CI：-8.6~9.9μg·m L-1）,当血药浓度数据处于低、中浓度（〈90μg·m L-1）时,2种方法所测定结果均值相近,且差异无统计学意义;当血药浓度数据处于高浓度（〉90μg·m L-1）时,2种测定方法所获得的数据存在显著性差异。结论临床用不同方法监测丙戊酸血药浓度时,对不同测定方法的差异应予以关注并作相应调整,尤其是当血药浓度范围〉90μg·m L-1时,HPLC法与FPIA法所测定结果之间不可直接进行比较分析。

Objective To compare high performance liquid chromatog- raphy （HPLC）, fluorescence polarization immunoassay （FPIA） and mass spectrometer （HPLC - MS） method for the determination of valproic acid in serum and to evaluate the correlations among three methods. Methods Two hundred and seven steady- state serum samples were collected from epileptic patients who had taken valproate. Three methods were employed to determine the concentration of valproic acid （VPA） and the results were analyzed to evaluate the correlation and difference. Results The results determined by three methods had high correlation. However, there was significant difference between HPLC and FPIA method. The concentration determined by FPIA was 0. 7 μg · mL-1 higher than that of HPLC （95 % CI ： - 8.6 ~ 9. 9 μg · mL- 1 ）. When the concentration of valproic acid was less than 90 μg· mL-1, the two meth- ods appeared no significant difference. While the concentration of valpro- ie acid was more than 90 μg · mL-1, there was significant difference be- tween the two methods. Conclusion It is necessary to pay attention to the difference among three methods when monitoring the concentration of valproic acid in clinical practice. When the concentration was more than 90 μg · mL-1, the results determined by HPLC and FPIA method could not be compared directly.