基于HPLC-DAD与LC-MS/MS法检测拉莫三嗪血药浓度结果分析及其经济学比较  

Comparison of lamotrigine serum concentrations detected by HPLC-DAD and LC-MS/MS and their cost-effectiveness

作　　者：黄文灿[1] 尚德为[1] 朱秀清[1] 朱永坚[1] 张明[1] 倪晓佳[1] 王占璋[1] 卢浩扬[1] 江晓佳[2] 胡礼军[3] 王佳佳[4] 温预关[1] 

机构地区：[1]广州医科大学附属脑科医院(广州市惠爱医院),广东广州510370 [2]暨南大学药学院,广东广州510632 [3]汕头大学医学院第一附属医院,广东汕头515041 [4]广州中医药大学,广东广州510405

出　　处：《中国医院药学杂志》2017年第21期2131-2134,共4页Chinese Journal of Hospital Pharmacy

基　　金：国家自然科学基金(编号:81403016);广州市医药卫生科技项目(编号:20141A011041);广东省自然科学基金(编号:2015A030313808);广东省医院药学研究基金(正大天晴基金)项目(编号:2017A12);广州市重点学科建设院内项目(编号:GBH2014-ZD07)

摘　　要：目的:通过比较高效液相色谱法(HPLC-DAD,以下简称HPLC)和高效液相串联质谱法(LC-MS/MS)测定的拉莫三嗪(LTG)血药浓度值,考察2种方法检测值的一致性,并进行经济学评价。方法:采用HPLC法和LC-MS/MS法分别测定117份癫痫患者体内拉莫三嗪血清样本,用Passing-Bablok回归法和Bland-Altman偏差图分析检测结果的一致性和差异性,并计算2种方法的成本-效益。结果:2种方法得到的拉莫三嗪血药浓度值比较无显著性差异(P=0.707),Passing-Bablok回归方程为LTGHPLC=1.074×LTGLC-MS/MS+0.071,Pearson相关系数为0.997。HPLC法检测结果比LC-MS/MS法偏高(0.216±0.347)μg·mL^(-1)(95%CI:-0.465~0.897)。当样本量>9例/d时,HPLC法取得收益>56.04元/d;样本量>16例时,LC-MS/MS法取得收益>36.46元/d,HPLC法收益>653.77元/d。当HPLC法达到最大检测量(58例/d),LC-MS/MS法检测量为66例/d时,2种方法产生的日收益相近(4 240.20元vs 4305.43元)。当检测量>85例/d时,LC-MS/MS法的收益>5 927.64元/d,远高于HPLC法。结论:HPLC法和LC-MS/MS法在检测拉莫三嗪血药浓度时具有良好的一致性;HPLC法仪器成本较低,适用于检测量<58例/d的情况;LC-MS/MS法仪器成本高,单位时间内检测量为HPLC法的3~4倍,日检测量>85例时,检测效益优于HPLC法。OBJECTIVE To compare the results of lamotrigine （LTG） concentration determined by high performance liquid chromatography with diode array detector （HPLC-DAD or HPLC） and mass spectrometer （LC-MS/MS） in serum,and evaluate the correlation and economy of two methods.METHODS Totally 117 serum samples of lamotrigine were detected by HPLC and LC-MS/MS,respectively.Pssing-Bablok regression and Bland-Altman bias plots were used to evaluate the correlation and difference of two methods,and the economy and rationality of two methods were assessed by using the cost-effectiveness analysis method.RESULTS There was no statistically significant difference between the two methods （P=0.707）.Passing-Balok regression equation was LTGHPLC=1.074 LTGLC-MS/MS＋0.071 and Pearson correlation co-efficient was 0.997.The bias of HPLC for LTG concentration was（0.216±0.347）μg·mL-1,higher than that by LC-MS/MS （95%CI：-0.465-0.897）.When daily sample size was 〉 9 cases,the profit of HPLC was 〉 56.04 yuan.With sample size 〉 16 cases,the profit of LC-MS/MS was 〉 36.46 yuan/day,while the profit of HPLC was 〉 653.77 yuan/day.When HPLC method achieves maximum sample size （58 cases/day） and the daily size of LC-MS/MS was 66 cases/day,two methods could produce similar daily profit （￥4 240.20 vs 4 305.43）.The profit of LC-MS/MS method was 〉 5 927.64 yuan/day with sample size 〉 85 cases,which was far higher than HPLC method.CONCLUSION There is a great correlation between LTG concentrations detected respectively by the two methods.The instrument cost of HPLC is lower than LC-MS/MS method,and HPLC is recommended for the situation of sample size 〈 58 cases/day.The detection amount of LC-MS/MS is 3 4 times higher than HPLC method,whose effectiveness is higher for sample size 〉 80 cases/day.

关 键 词：高效液相色谱法 高校液相串联质谱法 拉莫三嗪 血药浓度 经济学评价 

分 类 号：R927[医药卫生—药学]