两种方法用于抗癫痫药物血药浓度检测室内质量控制性能评价  

Performance Evaluation of Two Methods for Internal Quality Control of Plasma Concentration Detection of Antiepileptic Drugs

作　　者：张惠兰 赵婷[1,2] 冯杰 王婷婷[1,2] 李红健 于鲁海[1,2] ZHANG Huilan;ZHAO Ting;FENG Jie;WANG Tingting;LI Hongjian;YU Luhai(Department of Pharmacy,People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi,Xinjiang,China 830001;Institute of Clinical Pharmacy of Xinjiang Uygur Autonomous Region,Urumqi,Xinjiang,China 830001)

机构地区：[1]新疆维吾尔自治区人民医院药学部,新疆乌鲁木齐830001 [2]新疆维吾尔自治区临床药学研究所,新疆乌鲁木齐830001

出　　处：《中国药业》2023年第4期59-63,共5页China Pharmaceuticals

基　　金：新疆维吾尔自治区自然科学基金[2016D01C097]。

摘　　要：目的评价两种方法用于医院抗癫痫药物血药浓度检测项目的室内质量控制水平。方法收集2020年1月至2021年12月医院超高效液相色谱仪室内拉莫三嗪(LTG)、奥卡西平(OXC)和左乙拉西坦(LEV)血药浓度检测质量控制数据,应用Westgard标准决定图和6σ性能验证图分析各项性能可接受性。结果Westgard标准决定图性能评价结果中,除LTG和LEV中浓度分析性能良好外,其余项目均为优秀。6σ性能验证图评价结果中,3个药物的9个质控浓度σ值差异较小,除OXC和LEV低浓度分析性能为临界,LTG高浓度为优秀外,其余项目均为良好;各项目的质量目标指数(QGI)均小于0.8,需预先改善仪器精密度。结论两种性能评价方法均可精确评价抗癫痫药物血药浓度检测项目的室内质量控制水平,6σ性能验证图标准更严格,更能保证日常工作结果的准确性。Objective To evaluate the internal quality control(IQC)level of two methods used in the detection project of plasma concentration of antiepileptic drugs in the hospital.Methods The IQC data of ultra-high performance liquid chromatography(UPLC)from January 2020 to December 2021 for lamotrigine(LTG),oxcarbazepine(OXC)and levetiracetam(LEV)plasma concentrations in the hospital were collected,and the acceptability of each project was analyzed by Westgard standard decision chart and 6σperformance verification chart.Results Among the performance evaluation results of Westgard standard decision chart,except for the good analytical performance of the medium concentration of LTG and LEV,the other items were excellent.Among the evaluation results of 6σperformance verification chart,the difference of theσvalues of nine quality control concentrations of the three drugs was small.Except that the analytical performance of OXC and LEV at low concentrations was critical,and the high concentration of LTG was excellent,the other items were good.The quality goal index(QGI)of each item was less than 0.8,and the instrument precision needed to be improved in advance.Conclusion The two performance evaluation methods can accurately evaluate the IQC level of the test project of plasma concentration of antiepileptic drugs,and the standard of 6σperformance verification chart is more strict,which can better ensure the accuracy of daily work results.

关 键 词：超高效液相色谱仪 抗癫痫药物 血药浓度 室内质量控制 Westgard标准决定图 6σ性能验证图 

分 类 号：R969.1[医药卫生—药理学] R446[医药卫生—药学]