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Interlaboratory analysis of teicoplanin plasma concentration assays among Chinese laboratories

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单位: [1]Department of Pharmacy, China-Japan Friendship Hospital, Beijing, China [2]Department of Pharmaceutical Science, Beijing Hospital, National Center of Gerontology, Beijing, China
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关键词: high-performance liquid chromatography multicentral quality control teicoplanin therapeutic drug monitoring

摘要:
What is known and objective Teicoplanin is widely used for the treatment of infections caused by drug-resistant Gram-positive bacteria. Since there is a good correlation between trough levels and clinical outcome, therapeutic drug monitoring (TDM) is recommended to achieve better clinical curative effects. However, TDM of teicoplanin is not routine in China. So, a programme was initiated in 2017, including both HPLC method establishment and interlaboratory quality assessment, for the measurement of teicoplanin. Methods A main centre and a quality control centre were set up in the study. An HPLC-based method of teicoplanin determination in plasma was developed by the main centre. Analysis was performed using a Waters Symmetry C18 column (250 mm x 4.6 mm, 5 mu m). The mobile phase was NaH2PO4 (0.01 mol/L) and acetonitrile (75:25 v/v; pH 3.3), with a flow rate of 1.0 mL/min and a detection wavelength of 215 nm. Piperacillin sodium was selected as an internal standard (IS). Twenty-six additional TDM centres were then recruited to adopt this method. Then, all the centres were asked to take part in a quality control assessment evaluated by the quality control centre. Results For all TDM centres, linearity of teicoplanin concentration ranges was between 3.125 and 100 mu g/mL. Intraday and interday accuracies ranged from 87.1% to 118.4%. Intraday and interday precision ranged from 0.3% to 13.8%. Therapeutic drug monitoring centres all passed inter-room quality assessment. All samples tested met the acceptance criteria. Then, 542 samples were collected. Patients with sub-optimal (<= 10 mg/L) plasma teicoplanin concentrations constituted 42% of the total study population. What is new and conclusions For the first time, a simple, rapid and accurate HPLC method for determining teicoplanin levels was successfully applied to therapeutic drug monitoring in clinical practice for twenty-seven TDM centres in China. The results demonstrated excellent interlaboratory agreement for teicoplanin testing and provide support for clinical laboratory quality management and results inter-accreditation.

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 4 区 药学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 药学
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出版当年[2018]版:
Q3 PHARMACOLOGY & PHARMACY
最新[2023]版:
Q3 PHARMACOLOGY & PHARMACY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2018版] 出版当年五年平均[2014-2018] 出版前一年[2017版] 出版后一年[2019版]

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第一作者单位: [1]Department of Pharmacy, China-Japan Friendship Hospital, Beijing, China
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通讯机构: [1]Department of Pharmacy, China-Japan Friendship Hospital, Beijing, China [*1]Department of Pharmacy, China-Japan Friendship Hospital, 2 Yinghuadongjie Street, Chaoyang District, Beijing 100029, China
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