应用Westgard多规则理论评估万古霉素血药浓度监测的室内质控

Evaluation the quality control of blood drug monitoring of vancomycin using Westgard multi-rule theory

目的:探讨自制万古霉素质控血浆在血药浓度监测中的稳定性,应用Westgard多规则理论评估万古霉素血药浓度监测(TDM)的室内质量控制。方法:取万古霉素标准品12.20mg,50%甲醇溶解后加入空白血浆基质液,制备质量浓度分别为4.88,24.40,40.02μg·mL-1的万古霉素质控血浆,在连续25个工作日内对75个低、中、高质控浓度进行监测,绘制LeveyJennings质控图和Z-分数质控图,采用Westgard多规则进行质量评估。结果:万古霉素低、中、高室内质控的日内和日间RSD分别为0.59%～0.86%、3.90%～5.67%,回收率分别为98.90%～102.11%、102.93%～106.91%,符合《中国药典》2015年版(四部)生物样品测定的要求;绘制的质控图显示低、中、高浓度质控血浆均未出现失控。结论:自制万古霉素质控血浆操作方法简单、成本低、结果可靠,可以作为实验室日常质量控制;利用室内质控评价体系对TDM监测数据进行评估,可以保证血药浓度测定的准确性、可靠性,从而为临床合理化给药提供准确信息。

OBJECTIVE To investigate the stability of self-made vancomycin quality control plasma in monitoring blood drug concentration and evaluate the indoor quality control of blood drug concentration monitoring of vancomycin using Westgard multi-rule theory.METHODS 12.20 mg vancomycin was weighed and dissolved in 50% methanol solution to prepare the vancomycin control plasma. The mass concentrations of vancomycin in plasma were 4.88, 24.40 and 40.02 μg·mL^-1, respectively. A Levey-Jennings quality control chart and a Z-score quality control chart were generated by using 75 monitored samples with three different quality control concentrations in March and April of 2018, and Westgard multi-rules were also used for quality assessment.RESULTS The intra-day and inter-day RSDs of low, medium and high concentrations of vancomycin ranged from 0.59% to 0.86% and from 3.90% to 5.67%, respectively, while the recovery rates ranged from 98.90% to 102.11% and from 102.93% to 106.91%, respectively. This met the requirements of biological sample determination in China Pharmacopoeia. And the quality control charts showed that none of the control plasma with low, medium, and high concentrations was out of control.CONCLUSION The self-made vancomycin quality control has the advantages of simple operation, low cost, reliable results, and can be used as daily quality control in the laboratory. Application of indoor quality control system to evaluate TDM data can ensure the accuracy and reliability of blood drug concentration determination, which can provide accurate information for clinically rationalized drug administration.