LEITD与HPLC测定非典型抗精神病类药物血药浓度的比较研究  

Comparative study of LEITD and HPLC for determination of atypical antipsychotic drugs

作　　者：张琦[1] 沈薇[2] 史东风 王奕庆 钱小年 杨思杰 ZHANG Qi;SHEN Wei;SHI Dongfeng;WANG Yiqing;QIAN Xiaonian;YANG Sijie(Department of Clinical Laboratory,the Third Mental Health Center of Shanghai Civil Administration,Shanghai 200435,China;Renji Hospital Shanghai Jiao Tong University School of Medicine,Shanghai 200435,China)

机构地区：[1]上海市民政第三精神卫生中心检验科,上海200435 [2]上海交通大学医学院附属仁济医院,上海200435

出　　处：《检验医学与临床》2022年第15期2046-2049,2054,共5页Laboratory Medicine and Clinic

基　　金：上海市民政局局级科研课题项目(8-2-50)。

摘　　要：目的将采用胶乳增强免疫透射比浊法(LEITD)和高效液相色谱法(HPLC)同步为接受非典型抗精神病类药物治疗患者血液中抗精神病类药物血药浓度进行检测,分析两种方法检测结果的相关性和与治疗药物监测(TDM)的等效性。方法选取在上海市民政第三精神卫生中心2021年4-9月住院且进行TDM的219例患者作为研究对象,按服用不同种类非典型抗精神病类药物分组,其中服用利培酮为A组(100例)、奥氮平为B组(59例)和喹硫平为C组(60例);非典型抗精神病类药物低、中、高3个质量浓度质量控制样本和去离子水作为质量监测。各组采用同步盲法,按规定收集好样本后,将样本分成两份,编码后分别安排试验系统(LEITD)和对比系统(HPLC)进行各个药物血药浓度的测定,将测定结果按方法学分为两个数据库,两种方法测定结果运用SPSS25.0进行配对t检验、Spearman相关性分析及回归方程分析。结果LEITD与HPLC检测利培酮、喹硫平、奥氮平这3种非典型抗精神病类药物血药浓度结果差异均无统计学意义(P>0.05)。两种方法对喹硫平、奥氮平的测定结果具有良好的一致性。HPLC和LEITD对利培酮、喹硫平、奥氮平这3种非典型抗精神病类药物血药浓度的测定结果具有良好的相关性,且均呈正相关(r=0.944、0.993、0.991,P<0.05)。结论LEITD和HPLC对利培酮、喹硫平、奥氮平血药浓度的测定结果比较无明显差异,且具有良好的相关性。LEITD在TDM中具有一定的临床价值。Objective Latex immunoturbidimetry(LEITD)and high performance liquid chromatography(HPLC)were used to detect the blood concentration of atypical antipsychotic drugs in patients treated with antipsychotics simultaneously,in order to analyze the correlation between the two methods'detection data and the equivalence with therapeutic drug monitoring(TDM).Methods A total of 219 patients hospitalized in the Third Mental Health Center of Shanghai Civil Administration from April to September 2021 who were tested for antipsychotic drugs TDM were selected as the research objects.According to the differentatypical antipsychotic drugs taken,patients who took Risperidone was chosen as group A(100 cases),patients who took olanzapine was chosen as group B(59 cases),and patients who took quetiapine was chosen as group C(60 cases).Three quality control samples of low,medium and high concentration of atypical antipsychotic drugs and deionized water were used as quality monitoring.The synchronous blinding method was used in each group.After collecting the samples according to the regulations,the samples were divided into two parts.After the blinding,the test system(LEITD)and the comparison system(HPLC)were arranged to determine the concentration of each drug.The measurement results were divided into two databases according to methodology,and SPSS25.0 was used to perform paired t-test,Spearman correlation analysis and regression equation analysis for the measurement results of the two methods.Results There was no significant difference in the results of blood concentration of risperidone,quetiapine and olanzapine detected by LEITD and HPLC(P>0.05).The results of quetiapine and olanzapine determined by the two methods were in good agreement.The determination results of HPLC and LEITD on blood concentration of risperidone,quetiapine and olanzapine had good correlation,and the correlation was positive(r=0.944,0.993,0.991,P<0.05).Conclusion There is no significant difference the determination results of HPLC and LEITD on blood concentra

关 键 词：高效液相色谱法 胶乳增强免疫透射比浊法 治疗药物监测 抗精神病类药物 

分 类 号：R446.9[医药卫生—诊断学]