【作者】 鲁静； 陈岩； 郭美华； 钱钊； 曲婷； 段丽娟； 海鑫；

【Author】 Lu Jing;Chen Yan;Guo Meihua;Qian Zhao;Qu Ting;Duan Lijuan;Hai Xin;Department of Pharmacy,the First Affiliated Hospital of Harbin Medical University;

【机构】 哈尔滨医科大学附属第一医院药学部；

【摘要】 目的建立高效液相色谱法(HPLC)测定癫痫患者血浆中苯妥英浓度的方法,并与化学发光微粒子免疫检测法(CMIA)比较,进而评价2种测定方法的一致性。方法分别用HPLC法和CMIA法测定60例癫痫患者血浆中苯妥英的浓度,并对2种方法测定结果进行统计分析。对测定值采用双侧配对t检验比较差异,并用Passing-Bablok回归法和Bland-Altman偏差图法分析,考察2种方法的相关性及一致性。结果 2种方法测定结果的差异无统计学意义(P> 0.05)。2种方法的回归方程为Y=0.9929 X+0.1437 (R2=0.9926,n=60),显示2种方法相关性良好。Bland-Altman法分析表明2种测定方法的一致性良好。结论 HPLC法和CMIA法测定癫痫患者血浆中卡马西平的浓度具有较好的相关性与一致性,2种测定方法均可用于苯妥英浓度的测定。更多还原

【Abstract】 Objective To establish a high-performance liquid chromatography(HPLC) method for the determining of phenytoin concentration in epilepsy patients’ plasma, comparing with chemiluminescence microparticle immunoassay(CMIA). And evaluate the consistency of the two methods. Methods HPLC and CMIA methods were applied to determine the plasma concentration of phenytoin in 60 epileptic patients, respectively. The difference of results was analyzed by two-side paired t-test, and then investigate the correlation and consistency of the two methods with Passing-Bablok regression and Bland-Altman method. Results There was no significant difference between the results of two methods(P > 0.05). The regression equation of the determination results by HPLC(y) and CMIA(x) was Y = 0.9929 X + 0.1437(R~2 = 0.9926, n =60), which showed the correlation of the two methods is good. Bland-Altman analysis showed that the consistency of the two methods for determining was good. Conclusion HPLC and CMIA method in monitoring plasma concentration of phenytoin had good correlation and consistency. Both methods can be used for therapeutic drug monitoring of phenytoin.更多还原