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治疗药物监测已在国内普遍开展。测定血药浓度，制定安全、有效、合理的个体化给药方案，是其重要的内容之一。由于血药浓度测定结果是判断分析及制定个体化给药方案的最基本的科学依据，而测定误差受种种因素的影响又在所难免。因此，加强ＴＤＭ质控工作，确保血药浓度测定准确性和一致性就显得格外重要，它也是ＴＤＭ不可缺少的组成部分。本文阐述了治疗药物监测质量控制在ＴＤＭ中的重要作用，报道了我院于１９９０年在全军开展ＴＤＭ质控工作至今，取得了显著成绩。以允许误差在靶值的±１５％之内为合格标准，二十多个参加室间质控的实验室测定结果的合格率从最初的６２％逐步提高到最好成绩达９１％。同时，室间质控的数据为评价各种测定方法和各实验室测定结果的可靠性和可比性提供了有效的资料和依据。
Treatment drug monitoring has been carried out in China. Determination of blood concentration, to develop safe, effective and reasonable individualized drug delivery program is one of its important content. The result of determination of plasma concentration is the most basic scientific basis for judging and analyzing and formulating the individualized dosage regimen, and the measurement error is inevitably affected by various factors. Therefore, to strengthen the TDM quality control work to ensure the accuracy and consistency of the determination of plasma concentration is particularly important, it is also an integral part of TDM. This article describes the important role of quality control in the monitoring of therapeutic drugs in TDM and reports that our hospital made remarkable achievements in the quality control of TDM since 1990 in our army. To allow the error within ± 15% of the target value as a passing standard, more than 20 laboratories participating in laboratory quality control room pass the gradual increase from the initial 62% to the best score of 91%. At the same time, the data of laboratory quality control provide effective information and basis for evaluating the reliability and comparability of various measurement methods and laboratory measurement results.