摘要
目的:比较均相酶免疫法(HEIA)与液质联用法(LC-MS)检测人血清中卡马西平浓度结果。方法:入组110份临床样本,分别用2种方法测定,检验2组检测数据的正态性和显著性差异,采用Spearman法进行相关性分析,绘制Bland-Altman偏差图考察检测方法的差异性,Passing-Bablok回归法考察2种方法等效性。结果:HEIA法和LC-MS法的测定平均值分别为(8.23±5.59)μg·mL^(-1)和(6.19±4.35)μg·mL^(-1)。2组数据不呈正态分布,差异有统计学意义(P<0.05),呈高度相关(r=0.982 0)。2种方法测定值的差值的平均值为(29.5±21.3)%,且不同浓度水平差异相当,一致性较好。Passing-Bablok回归方程为:Y_(HEIA)=0.012 9+1.318 7X_(LC-MS),2种方法不具有等效性。结论:HEIA法比LC-MS法的检测值高,采用2种方法开展卡马西平治疗药物监测工作时,应考虑不同方法的测定差异值,根据临床实际疗效和安全性调整参考范围。
OBJECTIVE To compare the results of carbazepine in human serum detected by homogeneous enzyme immunoassay(HEIA)versusliquid chromatography-mass spectrometry(LC-MS).METHODS A total of 110 clinical samples were harvested and measured by two methods.Normality and significance of two datasets were examined.Spearman’s method was employed for correlation analysis.Bland-Altman deviation chart was plotted for examining the difference of two tests.And Passing-Bablok regression was utilized for investigating their equivalence.RESULTS The mean values of HEIA and LC-MS were(8.23±5.59)μg·mL^(-1)and(6.19±4.35)μg·mL^(-1)respectively.Neither dataset presented a normal distribution.There were significant inter-group differences(P<0.05)with a high correlation(r=0.982 0).The mean inter-group difference was(29.5±21.3)%.The difference in different concentration levels was similar and there was a decent consistency.The Passing-Bablok regression equation was Y_(HEIA)=0.012 9+1.318 7X_(LC-MS),and two methods werenot equivalent.CONCLUSION The test result of HEIA method was higher than that of LC-MS method.When two methods are applied for therapeutic drug monitoring of carbamazepine, the differentialvalue should be considered.And reference range should be adjusted according to the clinical efficacy and safety.
作者
毕重文
付广华
李丹青
胡祎明
顾芃
杨妙
李正翔
袁恒杰
BI Chong-wen;FU Guang-hua;LI Dan-qing;HU Yi-ming;GU Peng;YANG Miao;LI Zheng-xiang;YUAN Heng-jie(General Hospital,Tianjin Medical University,Tianjin 300020,China;College of Pharmacy,Tianjin Medical University,Tianjin 300070,China)
出处
《中国医院药学杂志》
CAS
北大核心
2021年第18期1852-1854,1874,共4页
Chinese Journal of Hospital Pharmacy
基金
天津市自然科学基金资助项目(编号:18JCQNJC83200)
天津医科大学总医院新世纪人才(编号:209060105201)。
关键词
均相酶免疫法
液质联用法
卡马西平
homogeneous enzyme immunoassay
liquid chromatography-mass spectrometry
carbamazepine