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Current Status of Serum Theophylline Standardization in Clinical Laboratories
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摘要: 茶碱是一种广泛应用于治疗哮喘和慢性阻塞性肺疾病的药物，但由于治疗窗口期较窄且个体差异大，因此需要准确监测血液中的浓度。目前临床实验室血清茶碱常用的检测方法包括免疫分析法、高效液相色谱法和液相色谱串联质谱法等，不同检测方法间检测结果存在一定的差异。目前茶碱的国际参考方法为同位素稀释气相色谱质谱联用（ID-GC/MS）参考测量程序。国内外均研制了茶碱的一级（纯度）参考物质，尚无血清基质的二级参考物质。为了确保测量结果的可靠性和一致性，有必要对茶碱的检测方法进行标准化，并建立完善的量值溯源体系。Abstract: Theophylline is a widely used medication for treating asthma and chronic obstructive pulmonary disease (COPD). It’s essential to accurately monitor the blood concentration of theophylline, due to the significant inter-individual variability and its narrow therapeutic window. Currently, immunoassays, high-performance liquid chromatography (HPLC), and liquid chromatography-tandem mass spectrometry (LC-MS/MS) are commonly used as routine methods for measuring serum theophylline in clinical laboratories. However, there is significant difference among the measurement results of these methods. The reference measurement procedure for serum theophylline in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database is the isotope dilution gas chromatography-mass spectrometry (ID-GC/MS) method. The primary reference material was developed by the UK Laboratory of the Government Chemist (LGC) and China National Institute of Metrology (NIM). No secondary reference material with serum matrix was reported. To ensure the reliability and harmonization of measurement results, it is important to establish a comprehensive traceability chain for the standardization of serum theophylline.
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Key words:
- metrology /
- theophylline /
- routine methods /
- standardization /
- reference measurement procedure /
- reference material
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