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Are there sufficient standards for the Emphasis Type="Italic"in vitro/Emphasis hemocompatibility testing of biomaterials?

机译:生物材料的体外血液相容性测试是否有足够的标准?

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In this perspective we address a fundamental and unresolved issue in biomaterials science: What are the molecular mechanisms which make a material blood compatible - or not? Despite the widespread use and the billion-dollar industry producing medical devices and implants, there is still a lack of fundamental understanding of the –admittedly– complicated and interlinked reactions that occur when an artificial material is exposed to blood. The increasing number of clinical reports about in vivo dysfunctional cardiovascular devices underlines the importance to understand –and be able to predict– the pathophysiological events occurring upon contact of blood with “hemocompatible” materials. The missing knowledge about the pathophysiological processes in the material/blood interphase and the lack of reliable correlations between in vitro-in vivo experiments, hinders us to develop scientific design principles to avoid complications in a clinical situation and achieve the optimal and lasting treatment. One may ask why this is the case, despite the huge research efforts taking place in laboratories worldwide to improve existing biomaterials and to develop new and better ones. One reason is certainly the analytical, intellectual and financial efforts it takes to unravel the interlinked biochemical reactions taking place in the interphase between the material and the body. But what actually slows the scientific community from developing models and theories on hemocompatibility is the fact that hardly any publication targeted at developing hemocompatible biomaterials conducts and describes the experiments and results in enough detail to allow a direct comparison to data in the literature or results of other laboratories. The lack of defined and certified positive or negative standards and experimental protocols even prevents us from concluding if a material is relatively better than another material, which may or may not be in use in medical practice. Hence, the literature is full with claims for “new” or “better” biomaterials, which have not undergone an in vitro side by side comparison to a standard, nor animal tests or clinical evaluation. If such in vitro comparisons with accepted standards would be performed according to standardized protocols, respective reports could contribute in a meaningful way to a database, which ultimately would provide the basis for a roadmap to better implants.
机译:从这个角度来看,我们解决了生物材料科学领域一个尚未解决的根本问题:使材料血液相容的分子机制是什么?尽管医疗器械和植入物的广泛使用和数十亿美元的产业生产,但对于人造材料暴露于血液时发生的(公认的)复杂且相互联系的反应仍然缺乏基本的了解。有关体内功能失调的心血管装置的临床报告数量不断增加,突显了理解并能够预测血液与“血液相容性”物质接触后发生的病理生理事件的重要性。关于物质/血液中间相的病理生理过程的知识的缺失以及体外-体内实验之间缺乏可靠的相关性,阻碍了我们制定科学的设计原则,以避免在临床情况下出现并发症并获得最佳和持久的治疗。也许有人会问为什么会这样,尽管全世界实验室都在进行大量研究以改进现有的生物材料并开发新的更好的材料。原因之一当然是需要进行分析,智力和财务方面的努力才能弄清在材料与人体之间的相间发生的相互关联的生化反应。但是,实际上使科学界放慢了开发血液相容性模型和理论的事实是,几乎没有任何旨在开发血液相容性生物材料的出版物能够进行并描述实验和结果的足够详细的信息,从而可以直接与文献数据或其他结果进行比较。实验室。缺乏确定和认证的肯定或否定标准和实验方案,甚至使我们无法确定一种材料是否相对优于另一种材料,而该材料可能在医学实践中使用或未使用。因此,文献中充斥着“新的”或“更好的”生物材料的主张,这些主张没有经过与标准的体外并排比较,也没有经过动物试验或临床评估。如果将根据标准化协议进行此类与公认标准的体外比较,则各自的报告将以有意义的方式对数据库做出贡献,这最终将为更好的植入物提供路线图的基础。

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