2014年2月全国全血治疗药物监测的室内质量控制结果分析

发布时间：2018-06-07 08:17

本文选题：全血治疗药物监测 + 室内质量控制　；参考：《中国临床药理学杂志》2015年18期

【摘要】：目的调查全血治疗药物监测(环孢霉素A、他克莫司、西罗莫司)室内质量控制的精密度现状。方法用基于英特网方式的室间质量评价软件系统收集参加2014年2月全国全血治疗药物监测室间质量评价的179家实验室的室内质量控制数据,用Excel 2007和SPSS 13.0对数据进行分析,并计算允许总误差(TEa)、1/3TEa和1/4Tea这3个项目的室内质量控制变异系数的通过率。结果最终分别有116家、108家和21家实验室回报了环孢霉素A、他克莫司、西罗莫司批号1的室内质量控制数据,59家、56家和4家回报了环孢霉素A、他克莫司、西罗莫司批号2的室内质量控制数据。约半数实验室(40.7%~57.1%)用伯乐检测系统。西罗莫司室内质量控制变异系数除累积1/4TEa的通过率在项目间差异有统计学意义外(P0.05),其余情况不同项目间的通过率差异无统计学意义(P0.05)。环孢霉素A各检测系统室内质量控制变异系数的通过率差异无统计学意义(P0.05)。他克莫司除累积室内质量控制不精密度在1/4TEa评价标准时的通过率不同检测系统间差异无统计学意义外(P0.05),其他3种情况差异均有统计学意义(P0.01)。结论西罗莫司是室内质量控制变异系数通过率最高的检验项目,环孢霉素A不存在不同检测系统间室内质控变异系数通过率的差异,而他克莫司存在。通过对当月和累积的室内质量控制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。
[Abstract]:Objective to investigate the precision of indoor quality control in whole blood therapy monitoring (cyclosporine A, tacrolimus, sirolimus). Methods Excel 2007 and SPSS 13.0 were used to analyze the indoor quality control data collected from 179 laboratories participating in the whole blood therapy monitoring laboratory quality evaluation in February 2014 using the internet-based indoor quality assessment software system. The passage rate of the coefficient of variation in indoor quality control was calculated for the three items, the total allowable error of 1 / 3 TEa and 1/4Tea. Results in the end, 116, 108 and 21 laboratories reported cyclosporine A, tacrolimus, sirolimus batch 1, indoor quality control data 59, 56, and 4 cyclosporine A, tacrolimus. Indoor quality control data for sirolimus batch 2. About half of the laboratories use the Bole detection system. The coefficient of variation of sirolimus indoor quality control had no statistical significance except that the pass rate of accumulated 1/4TEa was significantly different between items (P 0.05). There was no significant difference in the passing rate of the coefficient of variation of indoor quality control between different detection systems of cyclosporine A (P 0.05). Tacrolimus had no significant difference in pass rate among different detection systems except for accumulative inaccuracy of indoor quality control in 1/4TEa evaluation standard, but there were significant differences in other three conditions (P 0.01). Conclusion sirolimus is the highest test item for indoor quality control coefficient of variation. Cyclosporine A does not exist the difference of coefficient of variation of indoor quality control among different detection systems, but tacrolimus has. By monitoring the coefficient of variation of the indoor quality control data of the current month and accumulated, and comparing the coefficient of variation calculated by the indoor quality control data with the relevant requirements, It is possible to evaluate whether the inaccuracy level of the detection system meets the required quality requirements.
【作者单位】：北京医院卫生部临床检验中心;
【基金】：北京市自然科学基金资助项目(7143182)
【分类号】：R95

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