基于Levey-Jennings质控图联合Westgard多规则理论建立万古霉素治疗药物监测的室内质控评估方法  

Establishment of Internal Quality Control Evaluation Method for Therapeutic Drug Monitoring of Vancomycin Based on Levey-Jennings Quality Control Chart Combined with Westgard Multi-Rule Theory

作　　者：李会婷 吴妍[1] 张哲弢 史天陆 LI Huiting;WU Yan;ZHANG Zhetao;SHI Tianlu(Dept.of Pharmacy,the First Hospital Affiliated to University of Science and Technology of China/Anhui Provincial Hospital,Hefei 230001,China)

机构地区：[1]中国科学技术大学附属第一医院/安徽省立医院药剂科,合肥230001

出　　处：《中国医院用药评价与分析》2022年第6期722-725,734,共5页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:利用Levey-Jennings质控图联合Westgard多规则理论建立高效液相色谱法测定万古霉素血药浓度的室内质控方法,为万古霉素安全有效的个体化给药提供依据。方法:取万古霉素标准品,溶解后加入空白血清制得质量浓度分别为10、25和50μg/mL的质控血浆,进行方法学考察以评估其可行性;对2020年6—8月该院30份万古霉素质控品进行监测,绘制Levey-Jennings质控图及Z-分数质控图,结合Westgard多规则理论对室内质控进行评估并进行统计分析。结果:万古霉素血清质量浓度在2.5~100μg/mL线性良好,低、中、高浓度质控品的日内和日间精密度的RSD及回收率均符合《中华人民共和国药典:四部》(2020年版)中生物样品测定的要求;室内质控评价结果显示万古霉素失控1次,经分析,去除误差因素后未有失控出现。结论:万古霉素治疗药物监测室内质量控制体系的建立有助于提高血药浓度监测结果的准确性,为临床提供精准的个体化药学服务。OBJECTIVE:To establish the internal quality control evaluation method for therapeutic drug monitoring of vancomycin based on Levey-Jennings quality control chart combined with Westgard multi-rule theory,so as to provide references for rational clinical drug use.METHODS:Vancomycin standard was dissolved and blank serum was added to prepare quality control plasma with mass concentrations of 10μg/mL,25μg/mL and 50μg/mL,respectively,and methodological studies were carried out to assess the feasibility.Totally 30 vancomycin quality control samples in the hospital from Jun.to Aug.2020 were monitored,and Levey-Jennings quality control chart and Z-score quality control chart were drawn.Combined with Westgard multi-rule theory,internal quality control was evaluated and statistically analyzed.RESULTS:Vancomycin showed good linear relationship within the range of 2.5μg/mL to 100μg/mL.The intra-day and inter-day precision RSD and recoveries of the low,medium and high concentrations of the quality control samples met the requirements of the Pharmacopoeia of the People’s Republic of China:Ⅳ(2020 Edition)for the determination of biological samples.The internal quality control evaluation showed one loss of control of vancomycin.After analysis,there was no out of control after removing error factors.CONCLUSIONS:The establishment of internal quality control system for therapeutic drug monitoring of vancomycin can effectively improve the accuracy of blood drug concentration monitoring,and provide more accurate individualized pharmaceutical services for clinical practice.

关 键 词：Levey-Jennings质控图 Westgard多规则理论 万古霉素 血药浓度 质控 

分 类 号：R978.1[医药卫生—药品]