左乙拉西坦的治疗药物监测--干血斑采样合适吗？

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry Pub Date : 2025-03-14 DOI:10.1016/j.clinbiochem.2025.110913

Camilla Linder , Victoria Barclay , Mihaela Oana Romanitan , Stanislav Beniaminov , Isabella Ekheden

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引用次数: 0

摘要

背景：治疗性药物监测有助于预防癫痫发作和减少癫痫患者的副作用。静脉切开术是采血的黄金标准，但对儿童、孕妇和偏远地区的患者来说可能很困难。我们之前验证了卡马西平、拉莫三嗪、左乙拉西坦（LEV）和丙戊酸的干血斑（DBS）取样。本研究通过增加样本数并使用免疫化学和LC-MS/MS方法比较结果，进一步研究了先前验证中LEV比较的不确定性。此外，比较毛细血管DBS和静脉DBS，并评估邮寄过程中样品的稳定性。目的：比较血浆和毛细血管DBS中LEV浓度，评价毛细血管DBS在运输过程中的稳定性。方法：采集40例lev治疗患者的毛细血管和静脉血。采用免疫化学和液相色谱串联质谱法测定浓度。采用Passing-Bablok回归和Bland-Altman图对矩阵和方法进行比较。结果：回归分析无比例偏倚，Bland-Altman图显示方法间无偏倚。对于毛细血管DBS与血浆浓度，92.1%的值在平均值的20%以内。在毛细血管DBS和静脉DBS之间没有发现偏差，偏差在可接受的范围内。样品在邮寄过程中保持了稳定性。结论：毛细管DBS与血浆中LEV的浓度对比表明，LEV的治疗药物监测可以通过家庭自采样进行，DBS邮寄到实验室进行分析。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Therapeutic drug monitoring of levetiracetam – Is dried blood spot sampling suitable?

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Therapeutic drug monitoring of levetiracetam – Is dried blood spot sampling suitable?

Background

Therapeutic drug monitoring helps prevent seizures and minimize side effects in epilepsy patients. Phlebotomy is the gold standard for blood collection but can be difficult for children, pregnant women, and patients in remote areas. We previously validated dried blood spot (DBS) sampling for carbamazepine, lamotrigine, levetiracetam (LEV), and valproic acid. Uncertainties in LEV comparisons from the previous validation were further investigated in this study by increasing sample numbers and comparing results using both immunochemistry and LC-MS/MS methods. Additionally, capillary and venous DBS were compared, and the stability of samples during mail transport was assessed.

Aim

To compare LEV concentrations in capillary DBS and plasma, and to assess the stability of capillary DBS during transportation.

Method

Capillary and venous blood samples were collected from 40 LEV-treated patients. Concentrations were measured using immunochemistry and liquid chromatography tandem mass spectrometry methods. Comparisons between matrices and methods were analyzed with Passing-Bablok regression and Bland-Altman plots.

Results

No proportional bias was found in regression analysis and Bland-Altman plots showed no bias between methods. For capillary DBS versus plasma concentrations, 92.1 % of values were within 20 % of the mean. No bias was detected between capillary and venous DBS, with deviations within acceptable limits. Sample stability was maintained during mail transport.

Conclusion

The concentrations obtained for LEV in capillary DBS versus plasma showed that therapeutic drug monitoring of LEV can be performed as at-home self-sampling with DBS mailed to the laboratory for analysis.

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来源期刊

Clinical biochemistry 医学-医学实验技术

CiteScore

5.10

自引率

0.00%

发文量

151

审稿时长

25 days

期刊介绍： Clinical Biochemistry publishes articles relating to clinical chemistry, molecular biology and genetics, therapeutic drug monitoring and toxicology, laboratory immunology and laboratory medicine in general, with the focus on analytical and clinical investigation of laboratory tests in humans used for diagnosis, prognosis, treatment and therapy, and monitoring of disease.