PharmaNet Canada Inc., Québec, Canada.
J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Jul 15;901:79-84. doi: 10.1016/j.jchromb.2012.06.002. Epub 2012 Jun 12.
Hemolysis is a common phenomenon in clinical studies. Despite the growing interest in hemolysis matrix effect, how hemolysis impacts the representability of hemolyzed plasma samples was rarely evaluated. The purpose of this research is to perform such an evaluation by theoretical consideration and experiment. A formula for estimating the impact is proposed, which includes the degree of hemolysis and the drug's red blood cell (RBC): plasma concentration ratio. The impact of hemolysis on the representability of hemolyzed plasma samples is compound-dependant. Given the same degree of hemolysis, the stronger a drug binds to RBCs, the more significant the impact of hemolysis. For a drug with high affinity to RBCs, the results of hemolyzed plasma samples may not be useful even though they are accurate. There is an overall agreement between theoretical predication and experimental results. Among the ten different drug compounds tested, only methazolamide, which binds strongly to RBCs, showed significant change in plasma concentration due to hemolysis.
溶血是临床研究中的常见现象。尽管人们对溶血基质效应越来越感兴趣,但溶血如何影响溶血血浆样本的代表性却很少得到评估。本研究旨在通过理论考虑和实验来进行这种评估。提出了一种估计影响的公式,其中包括溶血程度和药物的红细胞(RBC):血浆浓度比。溶血对溶血血浆样本代表性的影响取决于药物。在相同的溶血程度下,药物与 RBC 结合得越强,溶血的影响就越显著。对于与 RBC 具有高亲和力的药物,即使结果准确,溶血血浆样本的结果也可能没有用处。理论预测和实验结果之间有总体一致性。在所测试的十种不同药物化合物中,只有与 RBC 结合较强的甲唑胺由于溶血而导致血浆浓度发生显著变化。