摘要
目的分别建立稳定、准确、简单的,用于血浆中伏立康唑浓度检测的高效液相色谱(HPLC)法和酶放大免疫分析(EMIT)法,并对2种方法进行对比性研究。方法按照生物样品分析要求,分别建立伏立康唑血药浓度HPLC与EMIT检测方法。之后使用该2种方法检测所收集的49例患者样本,记录结果,使用SPSS 21.0和MedCalc 19.0.7软件,考察2种方法检测结果的一致性。结果HPLC法标准曲线为y=5.8066x-0.0021(R2=0.9999),测量范围0.5~20.0 mg·L^-1;EMIT法标准曲线为A=R0+K[1/1+e^[a+b·(lnρ)]],测量范围0.5~16.0 mg·L^-1。2种方法均符合生物样品分析要求。剔除4例不符合样本后,45例患者体内伏立康唑血药浓度采用HPLC法和EMIT法检测结果分别为(3.50±2.09)mg·L^-1和(3.62±2.00)mg·L^-1。配对t检验尚不能认为2种方法检测结果不同(t=-1.59,P=0.12);2种检测方法结果之间的Pearson相关系数为0.969(P<0.0001),提示2种检测方法结果存在相关性。Bland Altman图显示43例(95.6%)位于95%一致性界限区间内;Passing Bablok回归方程为y=0.182+0.974x(n=45),模型线性关系无偏差(P=0.20)。结论本研究所建立的用于人血浆中伏立康唑浓度检测的HPLC法与EMIT法之间一致性较好,且优势互补,可满足临床生物样本分析需要。
AIM To establish a stable,accurate and simple method for monitoring concentration of voricona-zole by HPLC and enzyme-amplified immunoassay(EMIT),and to compare the 2 methods.METHODS A-ccording to the requirements of biological sample analysis,HPLC and EMIT monitoring methods for voriconazole plasma concentrations were established.Two methods were used to monitor the collected 49 patient samples,and the results were recorded.The correlation between the 2 methods was investigated using SPSS 21.0 and MedCalc 19.0.7 softwares.RESULTS The standard curve of HPLC method was y=5.8066x-0.0021(R2=0.9999),and the measuring range was 0.5-20.0 mg·L^-1;the standard curve of EMIT method wasA=R0+K[1/1+e^[a+b·(lnρ)]],the measuring range was 0.5-16.0 mg·L^-1,and the both methods were in line with biological sample analysis requirements.After excluding 4 cases that did not meet the sample,the HPLC method showed(3.50±2.09)mg·L^-1 and the EMIT method showed(3.62±2.00)mg·L^-1 respectively.Paired t-test could not be considered that the monitoring results of the 2 methods were different(t=-1.59,P=0.12).The Pearson correlation coefficient of the 2 monitoring methods was 0.969(P<0.0001).The Bland Altman plot showed that 43 patients(95.6%)were within the 95%limits of agreement.Passing Bablok regression analysis showed regression equation was y=0.182+0.974x(n=45),and the model linearity was unbiased(P=0.20).CONCLUSION Good correlation between HPLC and EMIT method in monitoring voriconazole concentration of human plasma is showed.Two methods have complementary advantages,which can meet the needs of clinical biological sample analysis.
作者
丁记者
林小青
温悦
江国才
吕佩瑜
欧阳华
DING Jizhe;LIN Xiaoqing;WEN Yue;JIANG Guocai;LYU Peiyu;OUYANG Hua(School of Pharmaceutical Sciences,Xiamen University,Xiamen 361102,China;Department of Pharmacy,Zhongshan Hospital Affiliated to Xiamen University,Xiamen 361004,China;School of Pharmacy,Fujian Medical University,Fuzhou 350004,China)
出处
《中国临床药学杂志》
CAS
2020年第4期266-271,共6页
Chinese Journal of Clinical Pharmacy
