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加巴喷丁干血斑分析作为血清检测的有效替代方法:一项桥接研究。

Dried blood spot analysis of gabapentin as a valid alternative for serum: a bridging study.

作者信息

Sadones Nele, Van Bever Elien, Van Bortel Luc, Lambert Willy E, Stove Christophe P

机构信息

Laboratory of Toxicology, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium.

Heymans Institute of Pharmacology, Ghent University, De Pintelaan 185, 9000 Ghent, Belgium.

出版信息

J Pharm Biomed Anal. 2017 Jan 5;132:72-76. doi: 10.1016/j.jpba.2016.09.036. Epub 2016 Sep 26.

Abstract

We evaluated the applicability of a validated GC-MS method for the determination of gabapentin in dried blood spots (DBS). Important for the acceptance of DBS sampling as an alternative sampling strategy is the possibility to base solid conclusions on the quantification. Therefore, bridging studies -studies in which the correlation between both DBS and a reference matrix (e.g. serum) is evaluated statistically- need to be conducted. To this end, a comparative study was set up to quantify gabapentin in both blood (DBS) and serum samples. Statistically significant differences between DBS and serum concentrations were found (p<0.001). A mean blood-to-serum ratio of 0.85 was observed, which is in line with expectations. Calculated serum concentrations (obtained by dividing the DBS concentrations by 0.85) demonstrated a good correlation with measured serum concentrations, with 87% of samples fulfilling the criterion for incurred sample reanalysis. Furthermore, our data indicate a good correlation between capillary and venous concentrations. Conclusively, this study demonstrated that DBS are a valid alternative to serum for the determination of gabapentin.

摘要

我们评估了一种经过验证的气相色谱-质谱联用(GC-MS)方法在测定干血斑(DBS)中加巴喷丁含量方面的适用性。对于接受DBS采样作为一种替代采样策略而言,基于定量得出可靠结论的可能性至关重要。因此,需要开展桥接研究——即对DBS与参考基质(如血清)之间的相关性进行统计学评估的研究。为此,我们开展了一项比较研究,以对血液(DBS)和血清样本中的加巴喷丁进行定量分析。研究发现DBS和血清浓度之间存在统计学上的显著差异(p<0.001)。观察到平均血-血清比值为0.85,这与预期相符。计算得出的血清浓度(通过将DBS浓度除以0.85获得)与实测血清浓度显示出良好的相关性,87%的样本符合再分析样本的标准。此外,我们的数据表明毛细血管血和静脉血浓度之间具有良好的相关性。总之,本研究表明,在测定加巴喷丁时,DBS是血清的一种有效替代物。

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