2010～2012年度治疗药物监测室间质评结果分析

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。

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

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 and 6 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 in 3 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 streng- thening quality control management and standardization, and it will provide the credible diagnostic reference for the clinical application.