【作者】 钱钊； 陈岩； 郭美华； 鲁静； 刘亮； 高春璐； 海鑫；

【Author】 QIAN Zhao;CHEN Yan;GUO Mei-hua;LU Jing;LIU Liang;GAO Chun-lu;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】 目的建立一种快速、实用的临床监测万古霉素血浆中药物浓度的高效液相色谱方法;探讨高效液相法(HPLC)与酶放大免疫测定法(EMIT)监测人血浆中万古霉素浓度结果的相关性和一致性;方法通过对色谱柱、流动相系统及比例、流速、波长等条件进行摸索实验以及方法学验证,确立最佳的HPLC法;分别采用HPLC法和EMIT法测定30例万古霉素患者的血药浓度,通过Passing-Bablok回归法进行相关性评价、配对t检验和Bland-Altman法进行一致性评价;结果两种监测方法的线性回归方程y=0.9556 x+0.5400(n=30),相关系数r=0.9925;t-test显示P> 0.05;Bland-Altman偏差图表明两种方法一致性良好。结论 HPLC法与EMIT法监测血浆中万古霉素浓度,两种监测方法具有良好的相关性与一致性,均可以应用于临床检测。更多还原

【Abstract】 OBJECTIVE To establish a rapid and pracitical method for monitoring the concentration of vancomycin in human plasma; To investigate the correlation and consistency of the high performance liquid chromatography(HPLC) and enzyme multiplied immunoassay technique(EMIT) for vancomycin monitoring. METHODS To optimize the chromatographic conditions, the chromatographic column, mobile phase and flow rate ratio, detection wavelength through a series of exploring experiments and method validation; then 30 patients’ samples who were treated withvancomycin, were determined by both HPLC and EMIT method. And Passing-Bablok regression method was used to evaluate the correlation, t-test and Bland-Altman method were used for the consistency of these two methods. RESULTS The two methods had good correlation. The linear regression equation was y = 0.9556 x + 0.5400(n = 30) and the correlation coefficient number was 0.9925; The paired samples t-test indicated P > 0.05, there is no significant difference; Bland-Altman evaluation reflexed that the 2 methods agreeded well. CONCLUTION HPLC and EMIT showed good agreement and consistency for monitoring the concentration of vancomycin. Both of them can be used for clinical therapeutic drug monitoring.更多还原