高效液相色谱法与化学发光微粒子免疫检测法测定血浆苯妥英浓度的一致性评价  

Comparison of HPLC and CMIA Method in Monitoring Concentration of Phenytoin in Epileptic Patients' Plasma

作　　者：鲁静[1] 陈岩[1] 郭美华[1] 钱钊[1] 曲婷[1] 段丽娟[1] 海鑫 

机构地区：[1]哈尔滨医科大学附属第一医院药学部,哈尔滨150001

出　　处：《医药导报》2017年第2期131-135,共5页Herald of Medicine

基　　金：哈尔滨医科大学创新科学研究资助项目(医学临床科学研究专项;2016LC2X52);哈医大一院科研基金(2015B017)

摘　　要：目的建立高效液相色谱(HPLC)法和化学发光微粒子免疫检测(CMIA)法测定癫痫间患者血浆苯妥英浓度,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例癫痫间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种方法测定结果差异无统计学意义(P>0.05)。2种方法回归方程为Y=0.992 9X+0.143 7(R^2=0.992 6,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法测定癫痫间患者血浆中苯妥英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。ObjectiveTo establish a high performance liquid chromatography （HPLC） method for determining phenytoin concentration in epilepsy patients＇ plasma, and compare this method with chemiluminescence microparticle immunoassay （CMIA）, and to evaluate the consistency of the two methods. MethodsHPLC 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 the correlation and consistency of the two methods were investigated with Passing-Bablok regression and Bland-Altman method. ResultsThere was no significant difference between the results of the two methods （P〉0.05）.The regression equation of the determination results by HPLC （Y） and CMIA （X） was Y=0.992 9X＋0.143 7 （R2=0.992 6,n= 60）, which indicated the correlation of the two methods was good. Bland-Altman analysis showed that the consistency of the two methods for determining was good. ConclusionHPLC and CMIA method in monitoring plasma concentration of phenytoin have good correlation and consistency. Both methods can be used for therapeutic drug monitoring of phenytoin.

关 键 词：苯妥英 色谱法 高效液相 化学发光微粒子免疫法 血药浓度 一致性 

分 类 号：R971.6[医药卫生—药品] R969.1[医药卫生—药学]