克洛沙平和N-desmethylclozapine (诺克洛沙平) 能力测试数据,2012-2024年
Lewis Couchman1, Karen Morgan2, Susanna Every-Palmer3
1Analytical Services International Ltd, St. George's-University of London, London, United Kingdom.
Therapeutic drug monitoring
|January 23, 2026
概括
血清克洛扎素能力测试显示液体染色学-质谱学使用增加并没有提高分析性能. 方法验证应解决潜在的干扰,而意想不到的结果需要重复分析.
科学领域:
- 临床化学 临床化学
- 药理学 药理学是指药理学的学科.
- 分析化学 分析化学
背景情况:
- 能力测试方案对于监测实验室在治疗药物监测中的表现至关重要.
- 克洛沙平和诺克洛沙平是必要的抗精神病药物,需要准确的量化.
- 评估用于克洛沙平和诺克洛沙平测试的分析方法对于患者安全至关重要.
研究的目的:
- 总结了来自血清克洛沙和诺克洛沙能力测试计划的数据.
- 评估分析方法对随时间推移的定量性能的影响.
- 为了确定克洛沙平和诺克洛沙平测量的潜在问题.
主要方法:
- 来自克洛扎和诺克洛扎能力测试计划 (2012-2024) 的月度回报分析.
- 追踪使用不同分析技术的实验室比例,包括液体染色学-质谱学 (LC-MS) 和高性能液体染色学 (HPLC).
- 使用z-score进行定量性能的评估,并分析报告的克洛扎和诺克洛扎度.
主要成果:
- 191个实验室参与,其中164个报告了诺克洛沙的结果.
- 到2024年,LC-MS的使用增加到74%,而HPLC的使用减少.
- 在6.8%的回报中报告了可检测的克洛扎宾度,其中一些高度报告为0"或低于量化极限.
- 在分析方法之间没有观察到量化性能 (z-score) 的时间差异.
- 当单独测量克洛沙平时,与测量克洛沙平和诺克洛沙平时相比,克洛沙平z-score的中位数远离零.
结论:
- 增加LC-MS的采用与克洛扎或诺克洛扎的分析性能改善没有相关性.
- 方法验证应包括对代谢物和联合使用药物的干扰的评估.
- 意想不到的定量结果需要重复分析或,如果可行,重复采样以进行临床确认.
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