中国药物警戒 ›› 2011, Vol. 8 ›› Issue (12): 755-759.

• 医院药事管理与合理用药 • 上一篇    下一篇

2010～2012年度治疗药物监测室间质评结果分析

闫颖1,张顺利2,钟1,任思楣1,马嵘1,王冬环1,张传宝1*   

  1. 1.卫生部北京医院卫生部临床检验中心,北京100730；#br# 2.北京协和医学院研究生院,北京100730
  • 收稿日期:2013-07-02 出版日期:2013-12-08 发布日期:2016-03-09
  • 通讯作者: 张传宝,男,博士,硕士生导师,临床检验诊断标准化研究。E-mail:cbzhang@nccl.org.cn
  • 作者简介:闫颖,女,硕士,助理研究员,临床检验标准化。

Analysis of External Quality Assessment Results for Therapeutic Drug Monitoring from 2010 to 2012

YAN Ying1 ,ZHANG Shun -li2 ,ZHONG Kun1 ,REN Si -mei1 ,MA Rong1 ,WANG Dong -huan1 ,ZHANG Chuan-bao1*   

  1. 1.Beijing Hospital, National Center for Clinical Laboratories, Beijing 100730, China; #br# 2.Beijing Union Medical College Graduate School, Beijing 100730, China
  • Received:2013-07-02 Online:2013-12-08 Published:2016-03-09

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摘要： 目的 分析2010～2012 年度治疗药物监测（TDM）项目室间质评结果,为提高TDM 检测质量提供依据。方法 收集2010～2012 年参加卫生部临床检验中心全血TDM 室间质评的3 次结果和血清TDM 室间质评医院的6 次调查结果,对结果进行统计分析。结果 全国开展全血TDM室间质评的医院数从2010 年88 家增加至2012 年102 家,开展血清TDM 室间质评的医院数从2010 年119 家增加至2012 年136 家。全血TDM 中,环孢霉素A、他克莫司、西罗莫司的3年平均合格率分别为94.2%、83.4%、89.1%。血清TDM中,茶碱、地高辛、苯妥英、丙戊酸、卡马西平的3年平均合格率分别为94.3%、81.9%、95.4%、96.7%、95.9%。参加实验室的所有方法中,偏振荧光免疫法的应用逐年减少,吖啶酯直接化学发光法和酶增强免疫分析法的应用逐年增加。在3 年195 个批号的室间质评中,约92.3%批次的方法间变异系数小于20%；7.2%批次方法间变异系数在20%～30%之间；0.5%批次的方法间变异系数大于30%。结论 我国TDM 室间质评检测质量尚有待提高,应加强TDM 的质量控制,推动TDM 检测结果的准确、可比,为临床提供可靠的诊疗依据。

关键词: 治疗药物监测, 室间质评

Abstract: Objective To analyze the external quality assessment(EQA) program Results for therapeutic drug monitoring (TDM) from 2010 to 2012 in China, and to provide the reference for improving the TDM determination quality .Methods Three times of blood TDM EQA Results and6 times of serum TDM EQA Results from 2010 to 2012 were collected and analyzed statistically by National Center for Clinical Laboratories(NCCL). Results From 2010 to 2011, the number of blood TDM EQA participants increased from 88 to 102, the serum TDM EQA participants increased from 119 to 136. In blood TDM EQA, the average qualified rate of cyclosporine A, tacrolimus, sirolimus in 3 years were 94.2%, 83.4% and 89.1%, respectively. In serum TDM, the average qualified rate of theophylline, digoxin, phenytoin, valproic acid, carbamazepine in3 year were 94.3%, 81.9%, 95.4%, 96.7% and 95.9%, respectively. In all the participated laboratories, the number of fluorescence polarization immunoassay(FPIA) decreased, the number of acridinium direct chemiluminescence and enzyme-multiplied immunoassay technique(EMIT) increased every year. Approximately 92.3% of the 195 lots of EQA, the coefficient of variation of the Methods were less than 20%, 7.2% of the lots, the coefficient of variation of Methods were between 20%～30%, and 0.5% of the lots, the coefficient of variation of Methods were more than 30%. Conclusion The determination accuracy and comparability for TDM should be improved by strengthening quality control management and standardization, and it will provide the credible diagnostic reference for the clinical application.

Key words: therapeutic drug monitoring, external quality assessment

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