应用多方法联合质控丙戊酸血药浓度监测

Multiple methods of quality control in the analysis of plasma concentration of valproic acid

目的对丙戊酸血药浓度质控监测数据绘制质控图,并进行连续性评估与分析,积累本实验室的质控趋势,提高误差检测灵敏度,确保药物浓度检测的准确性。方法对2013年8月—2014年7月丙戊酸低、中、高质控浓度133个监测数据绘制质控图,并采用Levey-Jennings质控方法结合Westgard多规则进行统计分析。结果不同的质控方法失控率不同,基于药典要求的质控失控率最高;依据说明书中的质控范围,失控率略低;而根据Levey-Jennings质控图结合Westgard多规则进行质控分析发现,失控率明显降低。结论通过对不同质控方法的对比分析,在长期进行血药浓度检测过程中,为提高检测结果的准确度,不能单一使用一种质控方法,应使用多种方法联合质控。

Objective To continuously assess and analyze valproic acid （VPA） via drug monitoring for quality control,to ac-cumulate lab quality control tendency, to improve sensitivity of determination, and to ensure the accuracy of therapeutic drug monitoring（TDM）. Methods The VPA quality control data were statistically analyzed,by using Levey-Jennings method eom-bined with Westgard rules. Results Ratio of out-of-control vary from one to another. The one on the basis of Levey-Jennings method combined with Westgard rules was the best, which was between that of Pharmacopoeia and instruction. Conclusion Through the comparative analysis of different quality control methods, not a single quality control method but a variety of methods should be used to improve the accuracy of test results during the long term blood drug concentration detection.