UPLC-MS/MS法和CMIA法测定人工关节假体周围感染患者万古霉素血药浓度效果比较  

Comparison of the Effects of UPLC-MS/MS and CMIA Methods in Determining the Blood Concentration of Vancomycin in Patients with Periprosthetic Joint Infection

作　　者：黄俊杰 何家伟[2,3] 闫可欣 常军民 HUANG Junjie;HE Jiawei;YAN Kexin;CHANG Junmin(College of Pharmacy,Xinjiang Medical University,Urumqi,Xinjiang,China 830054;The First Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China 830054;Xinjiang Key Laboratory of Clinical Drug Research,Urumqi,Xinjiang,China 830054;Xinjiang Key Laboratory of Natural Drug Release Technology,Urumqi,Xinjiang,China 830000)

机构地区：[1]新疆医科大学药学院,新疆乌鲁木齐830054 [2]新疆医科大学第一附属医院,新疆乌鲁木齐830054 [3]新疆药物临床重点实验室,新疆乌鲁木齐830054 [4]新疆天然药物活性组分与释药技术重点实验室,新疆乌鲁木齐830000

出　　处：《中国药业》2025年第6期55-59,共5页China Pharmaceuticals

基　　金：新疆维吾尔自治区自然科学基金[2022D01C240];武汉药学会第二届医院药学学科发展项目孵化营项目[WHPA202305011]。

摘　　要：目的探讨超高效液相色谱串联质谱(UPLC-MS/MS)法和化学发光微粒子免疫法(CMIA)测定人工关节假体周围感染(PJI)患者血中万古霉素浓度的差异。方法采用UPLC-MS/MS法和CMIA法分别检测43份PJI患者万古霉素血药谷浓度(C_(min))标本,采用Shapiro-Wilk正态性检验、Spearman相关分析、Cusum检验法、Passing-Bablok回归分析、Bland-Altman图等进行统计学分析,评价两种方法的相关性和一致性。结果两种方法的检测结果呈非正态分布。Passing-Bablok回归方程结果提示存在比例系统误差,Spearman相关分析结果显示两种方法测定结果呈极强相关性(R=0.970,P<0.0001),Bland-Altman图显示两种方法的一致性不理想,UPLC-MS/MS法较CMIA法存在13.93%的负偏倚。结论UPLC-MS/MS和CMIA法测定PJI患者万古霉素血药浓度的相关性较好,但一致性欠佳,两种方法不可直接互换使用。Objective To investigate the differences between ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)and chemiluminescent microparticle immunoassay(CMIA)methods for the measuring vancomycin concentration in the blood of patients with prosthetic joint infection(PJI).Methods The vancomycin trough blood concentrations(C_(min))in 43 specimens from PJI patients were measured using the UPLC-MS/MS method and CMIA method respectively.Statistical analyses including Shapiro-Wilk normality test,Spearman correlation analysis,CUSUM test,Passing-Bablok regression analysis,and Bland-Altman plots were performed to evaluate the correlation and agreement between the two analytical methods.Results The detection results of the two methods showed a non-normal distribution.The Passing-Bablok regression equation indicated the existence of a proportional systematic error.Spearman correlation analysis demonstrated a strong correlation between the results obtained by the two methods(R=0.970,P<0.0001).The Bland-Altman plots revealed that the consistency between the methods was unsatisfactory.Specifically,the UPLC-MS/MS method showed a negative bias of 13.93%when compared to the CMIA method.Conclusion The UPLC-MS/MS and CMIA methods exhibit a strong correlation in measuring vancomycin blood concentration in patients with PJI.However,the agreement between the two methods is not satisfactory,and thus they cannot be used interchangeably without further evaluation and consideration.

关 键 词：关节假体周围感染 超高效液相色谱串联质谱 CMIA 血药浓度 万古霉素 正态性检验 化学发光微粒子免疫法 非正态分布 

分 类 号：R969[医药卫生—药理学]