摘要
目的调查全国血清治疗药物监测（卡马西平、地高辛、苯妥英、茶碱、丙戊酸）室内质量控制的精密度现状,并与目前所确定的室内质量控制精密度的评价标准进行比较,提出改进措施。方法采用基于Web方式的室间质量评价（EQA）软件系统,收集2014年2月份参加全国血清治疗药物监测EQA计划的175家实验室的室内质量控制数据,包括当月的和累积的室内质量控制变异系数、质控规则、所使用的方法、仪器、室内质控品的厂家等信息。使用Microsoft Excel 2013和SPSS 13.0对数据进行分析。将EQA范围（地高辛为20%,其余项目为25%）定义为允许总误差（TEa）,将1/3TEa和1/4TEa定义为允许不精密度的评价标准,计算这5个项目的室内质量控制变异系数的通过率。血清治疗药物监测项目的允许不精密度评价标准为8.33%（1/3TEa）和6.25%（1/4TEa）,地高辛为6.67%（1/3TEa）和5%（1/4TEa）。结果分别有94家、97家、61家、43家和116家实验室回报了卡马西平、地高辛、苯妥英、茶碱、丙戊酸的室内质控数据。〉60%的实验室（63.93%-76.29%）使用伯乐检测系统,只有〈40%的实验室（23.71%-36.07%）使用其他检测系统。不同项目间的室内质控变异系数通过率都存在显著统计学差异,卡方值为10.689-19.255,均P〈0.05。不同检测系统间,只有丙戊酸在当月和累积不精密度在1/3TEa时的通过率存在显著统计学差异（P〈0.05）。结论通过对当月和累积的室内质控数据的变异系数的监测,并将室内质量控制数据计算的变异系数与相关要求进行比较,可以评价该检测系统的不精密度水平是否满足规定的质量要求。
Objective To investigate the coefficient of variations（CV） of internal quality control（IQC） of therapeutic drug monitoring in serum （carbamazepine, digoxin, phenytoin, theophylline and valproic acid）, and compare with the quality specification derived from allowable total error （TEa）. Methods Data was collected by Web-based submission system, the 175 laboratories which enrolled in 2014 therapeutic drug monitoring in serum external quality assessment （EQA） program attended. The data included： the CV of February of 2014 and long-term cumulative data, method and instrument, etc. Microsoft Excel 2013 and SPSS 13.0 was used to analyze the data.The evaluation standard of EQA was considered as TEa（25%and 20% for digoxin）. 1/3TEa （8.33% and 6.67% for digoxin） and 1/4TEa （6.25% and 5% for digoxin）were determined to be the evaluation standard of CV of IQC. Results From 175 laborctories 94, 97, 61, 43 and 116 laboratories reported effective results of IQC material of carbamazepine, digoxin, phenytoin, theophylline and valproic acib, respectively. More than 60% laboratories used Bio-Rad measurement system（63.93%-76.29%）. Less than 40%laboratories used other measurement systems（23.71%-36.07%）. There were significant differences （P〈0.05） of the acceptable rates of CV between test items （χ^2： 10.689-19.255, P〈0.05）. There was no significant difference of the acceptable rate of CV between different measurement systems except valproic acid evaluated by 1/3TEa （P〈0.05）. Conclusion It is an effective method for clinical laboratories to improve test quality by monitoring the current and cumulative CV of IQC and comparing them against proper evaluation criteria to evaluate if the analysis system can meet specific quality requirements or technical specification.
出处
《国际药学研究杂志》
CAS
CSCD
北大核心
2015年第3期386-389,393,共5页
Journal of International Pharmaceutical Research
基金
北京市自然科学基金资助项目(7143182)
关键词
血清治疗药物监测
室内质量控制
变异系数
卡马西平
地高辛
苯妥英
茶碱
丙戊酸
therapeutic drug monitoring in serum
internal quality control
coefficient of variation
carbamazepine
digoxin
phenytoin
theophylline
valproic acid
