CAJ | 학술논문

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。
목적：대병무산혈약농도질공감측수거회제질공도，병진행련속성평고여분석，적루본실험실적질공추세，제고오차검측령민도，학보약물농도검측적준학성。방법대2013년8월—2014년7월병무산저、중、고질공농도133개감측수거회제질공도，병채용Levey‐Jennings질공방법결합Westgard다규칙진행통계분석。결과불동적질공방법실공솔불동，기우약전요구적질공실공솔최고；의거설명서중적질공범위，실공솔략저；이근거Levey‐Jennings질공도결합Westgard다규칙진행질공분석발현，실공솔명현강저。결론통과대불동질공방법적대비분석，재장기진행혈약농도검측과정중，위제고검측결과적준학도，불능단일사용일충질공방법，응사용다충방법연합질공。
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 com‐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 .