在全血微样本,血和血超液中快速,可靠的LC-MS/MS量化塞法林:分析方法验证和在儿科患者中初步临床应用
Arkadiusz Kocur1, Agnieszka Czajkowska1, Mateusz Moczulski1
1Therapeutic Drug Monitoring, Clinical Pharmacokinetics and Toxicology Laboratory Unit, Department of Clinical Biochemistry, The Children's Memorial Health Institute, 04-730 Warsaw, Poland.
Clinica chimica acta; international journal of clinical chemistry
|December 27, 2025
概括
一种新的液体染色学-双重质谱法准确地测量了小儿科患者使用微量取样的塞法林. 这种测定支持在重症监护机构中精确剂量测定塞法林.
科学领域:
- 药理学 药理学是指药理学的学科.
- 分析化学 分析化学
- 儿科重症监护 儿科重症监护
背景情况:
- 在儿科重症监护病房 (ICU) 中,最佳的头类胺剂量是具有挑战性的,因为药物动力学变异性和血量有限.
- 在儿科重症监护中,治疗药物监测 (TDM) 缺乏经过验证的微采样分析.
研究的目的:
- 开发和验证一种快速,可靠的液体染色学-并联质谱法 (LC-MS/MS) 方法来测量塞法林度.
- 为了使TDM和药理动力学/药理动力学 (PK/PD) 研究在儿科ICU患者使用微量采样技术.
主要方法:
- 开发并验证了通过体积吸收微样采集 (VAMS) 收集的血,超和毛细血管全血中塞法索林的LC-MS/MS试验.
- 利用逆相HPLC和双重质谱,使用cefotaxime-D3作为内部标准.
- 根据ICH M10指南验证了该方法,评估了选择性,线性,准确性,精度和稳定性等参数.
主要成果:
- 在所有矩阵中实现了3分钟的运行时间,具有0.5 mg/L的下限量化值 (LLOQ).
- 在各个质量控制级别中表现出极好的线性 (R2>0.995),准确性和精度 (在±15%以内).
- 在各种分析前条件和VAMS特异性因素 (血位,干燥时间) 下证实了塞法佐林的稳定性.
结论:
- 开发的多矩阵,微采样兼容的LC-MS/MS测定是敏感的,具体的,并且可用于常规的TDM和PK/PD研究.
- 这种测定有助于为新生儿和儿科重症监护提供精确的塞法林剂量方案.
- 该方法支持在脆弱的儿科群体中优化抗生素治疗.
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