Establishment of Internal Quality Control Method for Blood Concentration of Theophylline

MIAO Renhua; ZHUANG Xingxing; ZHANG Peng

doi:10.14009/j.issn.1672-2124.2021.04.014

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Establishment of Internal Quality Control Method for Blood Concentration of Theophylline

更新时间：2022-10-08

- Establishment of Internal Quality Control Method for Blood Concentration of Theophylline
- Vol. 21, Issue 4, Pages: 441-443(2021)
- 作者机构：
  
  安徽医科大学附属巢湖医院药剂科
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2021.04.014
  CLC： R969.1
- Published：2021，
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[1]苗仁华,庄星星,张鹏.茶碱血药浓度室内质量控制方法的建立[J].中国医院用药评价与分析,2021,21(04):441-443+450.

MIAO Renhua, ZHUANG Xingxing, ZHANG Peng. Establishment of Internal Quality Control Method for Blood Concentration of Theophylline. [J]. 21(4):441-443(2021)
[1]苗仁华,庄星星,张鹏.茶碱血药浓度室内质量控制方法的建立[J].中国医院用药评价与分析,2021,21(04):441-443+450. DOI： 10.14009/j.issn.1672-2124.2021.04.014.

MIAO Renhua, ZHUANG Xingxing, ZHANG Peng. Establishment of Internal Quality Control Method for Blood Concentration of Theophylline. [J]. 21(4):441-443(2021) DOI： 10.14009/j.issn.1672-2124.2021.04.014.

摘要

目的:运用Westgard多规则理论建立酶联免疫法测定茶碱血药浓度的室内质量控制方法。方法:制备茶碱质控血清5.0、10.0及20.0μg/ml

在连续20个工作日内对上述低、中及高浓度的质控血清进行监测

绘制Levey-Jennings质控图和Z-分数质控图

采用Westgard多规则进行质量评估。结果:茶碱低、中及高浓度质控血清的精密度、稳定性和回收率试验结果均符合要求; Levey-Jennings方法和Westgard多规则控制方法均未提示失控情况。结论:利用室内质量控制评价体系对茶碱血药浓度监测数据进行评估

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。

Abstract

OBJECTIVE: To establish an internal quality control method for the blood concentration of theophylline by enzyme-linked immunosorbent assay（ ELISA） using Westgard multiple rules theory. METHODS: 5. 0 μg/ml

10. 0 μg/ml and 20. 0 μg/ml of quality control serum of theophylline were prepared

after 20 consecutive working days of monitoring on low

medium and high concentration of quality control serum

Levey-Jennings quality control charts and Z-score quality control charts were plotted

and Westgard multiple rule was used for its quality assessment.RESULTS: The precision

stability and recovery test results of the low

medium and high concentration of quality control serum of theophylline were all in accordance with the requirements; both the Levey-Jennings method and Westgard multiple rule control method suggested no uncontrolled situations. CONCLUSIONS: Using the internal quality control assessment system to conduct evaluation on blood concentration monitoring data of theophylline can ensure the accuracy and reliability of blood concentration determination

thus providing accurate information for clinical rational drug administration.

关键词

茶碱血药浓度治疗药物监测室内质量控制

Keywords

Blood concentration monitoring of theophyllineTherapeutic drug monitoringInternal quality control

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