HPLC法与CMIA法监测癫痫患者血浆中苯巴比妥浓度的一致性评价  

Consistent analysis of HPLC and CMIA method in TDM of phenobarbital in epileptic patients' plasma

作　　者：钱钊[1] 郭美华[1] 陈岩[1] 鲁静[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,黑龙江哈尔滨150001

出　　处：《中国药物应用与监测》2016年第2期80-84,共5页Chinese Journal of Drug Application and Monitoring

基　　金：哈尔滨医科大学附属第一医院科研基金(2016B010)

摘　　要：目的:建立高效、实用的癫痫患者苯巴比妥药物浓度监测方法,评价高效液相色谱(HPLC)法与化学发光微粒子免疫(CMIA)法的相关性和一致性。方法:分别采用HPLC法和CMIA法监测55例癫痫患者血浆中苯巴比妥的药物浓度,利用Passing-Bablok回归法、配对t检验法和Bland-Altman法分析,考察两种方法的相关性及一致性。结果:以两种方法的测定结果作回归方程为Y=1.024 1 X+0.349 2(r=0.988,n=55),显示两种方法相关性良好;配对t检验(P>0.05)和Bland-Altman法分析结果表明二者的一致性良好。结论:HPLC法和CMIA法监测癫痫患者血浆中苯巴比妥的药物浓度具有较好的相关性与一致性,可以相互替代,均可用于临床监测治疗药物浓度。Objective： To establish a practical and reliable method to quantify phenobarbital in epileptic patients＇ plasmafor therapeutic drug monitoring （TDM）, and evaluate the correlation and consistency of high-performance liquid chromatography（HPLC） and chemiluminescence microparticle immunoassay （CMIA）. Methods： HPLC and CMIA methods were used to monitorthe plasma concentration of phenobarbital in 55 epileptic patients, respectively. Then the correlation and consistency of the twomethods were analyzed by Passing-Bablok regression, Paired t-test and Bland-Altman analysis. Results： The regression equationof the determination results by HPLC （Y ） and CMIA （X ） was Y = 1.024 1 X ＋ 0.349 2 （r = 0.988, n = 55）, which suggested goodcorrelation of the two methods. Paired t-test （P 〉 0.05） and Bland-Altman analysis suggested a good consistency of the two methodsfor determining the plasma concentration of phenobarbital. Conclusion： HPLC and CMIA methods had good correlation andconsistency in TDM of phenobarbital. These two methods can be replaced by each other and used for clinical TDM.

关 键 词：高效液相色谱法 化学发光微粒子免疫法 苯巴比妥 治疗药物浓度监测 一致性 

分 类 号：R742.1[医药卫生—神经病学与精神病学]