一种LC-MS/MS方法的分析验证,用于在微体积全血中同时量化多种免疫抑制剂
Kenichi Aizawa1,2, Natsuka Kimura1, Takahiro Goda3
1Division of Translational Research, Clinical Research Center, Jichi Medical University Hospital, Shimotsuke 329-0498, Tochigi, Japan.
International journal of molecular sciences
|July 12, 2025
概括
一种新的液体染色体-并联质谱法方法可以同时量化全血中氨酸抑制剂 (CI) 和酸 (MPA) 等免疫抑制剂,从而减少患者负担和实验室复杂性.
科学领域:
- 临床化学 临床化学
- 分析化学 分析化学
- 药理学 药理学是指药理学的学科.
背景情况:
- 免疫抑制剂对于预防异构移植排斥至关重要,但需要治疗药物监测.
- 氨酸抑制剂 (CIs) 分布在红细胞中,而氨酸 (MPA) 在血中,需要单独分析.
- 目前的方法增加了实验室的工作量,分析复杂性和患者负担.
研究的目的:
- 开发一种单一的液体染色学-并联质谱法 (LC-MS/MS) 方法,用于同时定量多种免疫抑制剂.
- 减少治疗药物监测中的样本量要求和分析复杂性.
- 评估新方法与传统免疫试验的性能.
主要方法:
- 开发了一种LC-MS/MS方法,用于同时量化塔克罗利斯,埃弗罗利斯,西罗利斯,环素A和MPA.
- 使用2.8μL全血样本,对等于血的MPA度进行基于血红素的校正.
- 将LC-MS/MS结果与使用线性回归和布兰德-阿尔特曼分析的常规免疫试验数据进行比较.
主要成果:
- 与传统方法取得了很好的一致性 (CI的R2> 0.995,MPA和塔克罗利斯的R2> 0.900).
- 在所有测量分析物的临床相关度范围内表现出强烈的线性.
- 验证了同时定量方法的高准确性和可重复性.
结论:
- 开发的LC-MS/MS方法允许从一个小的全血体积同时量化关键的免疫抑制剂.
- 这种方法简化了治疗药物监测,减少了患者的负担,并有利于特定人群 (儿科,有限的静脉接入).
- 该方法为当前的多试验协议提供了一种更有效和潜在的成本效益更高的替代方案.
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