1999～2001年全国治疗药物监测室间质评结果

目的:通过开展室间质量评价活动提高临床实验室的检验结果质量。方法:每年向参加治疗药物监测(TDM)室间质量评价活动的单位发放质控品10个批号,测定项目包括茶碱、地高辛、苯妥英、苯巴比妥、卡马西平和环孢菌素A,实验室用常规方法测定并回报测定结果,经计算机软件对全部结果进行统计分析。结果:2001年参加TDM室间质评的实验室数为48家,测定结果的平均及格率分别为茶碱94.2％、地高辛82.6％、苯妥英83.8％、苯巴比妥88.4％、卡马西平94.2和环孢菌素A92.4％。1999～2001年全国TDM室间质评的年平均及格率分别为78.7％、84.7％和89.3％。不同测定方法的精密度分别为茶碱4.4％～14.2％、地高辛11.5％～21.9％、苯妥英8.5％～29.5％、苯巴比妥8.2％～13.9％、卡马西平10.8％～12.6％和环孢菌素A15.5％～16.6％。结论:多数参加TDM室间质评实验室的测定结果有较好的一致性,及格率逐年上升,但参加TDM室间质评的实验室数占开展TDM的实验室总数的比例较低,在不同的测定方法间还存在较大的差异。

Results of TDM External Quality Assessment in 1999 to 2001

Objective: Subject Improving the Quality of clinical laboratory results by external quality assessments (EQA). Methods! 10 lots of quality control samples were send to each laboratories who participate the TDM EQA program. The concentration of theophyline, digoxin, phenytoin, phenobarbital, carbamazepine and cyelosporine were determined by routine methods in laboratories. The results were analyzed by computer software. Results: 48 Laboratories joined the EQA program of TDM in 2001. The item average successful rates were theophyline 94.2% , digoxin 82.6%, phenytoin 83.8% , phenobarbital 88,4%, carbamazepine 94.2% and cyelosporine 92.4%, respectively. The annual average successful rates from 1999 to 2001 were 78.7% .84,7% and 89.3%, respectively. The precision amount different methods were theophyline 4.4% - 14.2% . digoxin 11,5% - 21.9% . phenytoin 8.5% -29.5%,phenobarbital 8.2% - 13.9%.earbamazipine 10.8% - 12.6% and eyclosporine 15.5% - 16.6% .Conclusion: Most of laboratories could get successful results in EQA program for TDM and the average successful rate was improved every year. Some laboratories who do TDM assay but did not join the EQA program for TDM, The precision of methods were different.