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两种不同灭菌方法的壳聚糖神经导管的体内长期评价

Long-Term In Vivo Evaluation of Chitosan Nerve Guide Properties with respect to Two Different Sterilization Methods.

机构信息

Institute of Neuroanatomy and Cell Biology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.

Center for Systems Neuroscience (ZSN), 30559 Hannover, Germany.

出版信息

Biomed Res Int. 2018 Jun 4;2018:6982738. doi: 10.1155/2018/6982738. eCollection 2018.

DOI:10.1155/2018/6982738
PMID:29967779
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6008694/
Abstract

Severe peripheral nerve injuries are reconstructed either with autologous nerve grafts (gold standard) or alternatively with clinically approved artificial nerve guides. The most common method used to sterilize these medical products is ethylene oxide gassing (EO). However, this method has several disadvantages. An alternative, which has been barely studied so far, represents beta irradiation (). In previous studies, we developed an artificial nerve guide made of chitosan (chitosan nerve guide, CNG), a biomaterial that is known to potentially retain toxic residues upon EO sterilization. Therefore, we analyzed the long-term regeneration-supporting and mechanical properties of CNGs upon their sterilization with EO or and their following application in unilateral repair of 12 mm gaps of the rat sciatic nerve. Over a period of 76 weeks, we serially evaluated the recovery of motor functions, the possible emergence of an inflammation in the surrounding connective tissue, the regrowth of axons into the distal nerve, and possible changes in the material properties. Our first long-term evaluation did not reveal significant differences between both sterilization methods. Thus, is as appropriate as commonly used EO for sterilization of CNGs; however, it may slightly increase the stiffness of the biomaterial over time.

摘要

严重的周围神经损伤可通过自体神经移植(金标准)或临床认可的人工神经导管进行修复。这些医疗产品最常用的灭菌方法是环氧乙烷气体灭菌(EO)。然而,这种方法有几个缺点。一种替代方法,到目前为止几乎没有研究过,代表β辐照()。在之前的研究中,我们开发了一种壳聚糖(壳聚糖神经导管,CNG)人工神经导管,这种生物材料已知在 EO 灭菌后可能会残留有毒物质。因此,我们分析了 EO 或 对 CNG 进行灭菌后,以及随后在大鼠坐骨神经 12mm 间隙单侧修复中的长期再生支持和机械性能。在 76 周的时间里,我们连续评估了运动功能的恢复、周围结缔组织中可能出现的炎症、轴突向远端神经的再生以及材料性能的可能变化。我们的首次长期评估并未显示两种灭菌方法之间存在显著差异。因此,与常用的 EO 相比, 对于 CNG 的灭菌同样适用;然而,随着时间的推移,它可能会略微增加生物材料的刚度。

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本文引用的文献

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Anat Rec (Hoboken). 2018 Oct;301(10):1697-1713. doi: 10.1002/ar.23847. Epub 2018 May 16.
2
Sterilization of implantable polymer-based medical devices: A review.可植入聚合物基医疗器械的灭菌:综述。
Int J Pharm. 2018 Jun 15;544(2):455-460. doi: 10.1016/j.ijpharm.2017.12.003. Epub 2017 Dec 20.
3
Two-Chambered Chitosan Nerve Guides With Increased Bendability Support Recovery of Skilled Forelimb Reaching Similar to Autologous Nerve Grafts in the Rat 10 mm Median Nerve Injury and Repair Model.具有增强柔韧性的双腔壳聚糖神经导管支持大鼠10毫米正中神经损伤与修复模型中熟练前肢抓握功能的恢复,效果类似于自体神经移植。
Front Cell Neurosci. 2019 May 10;13:149. doi: 10.3389/fncel.2019.00149. eCollection 2019.
Reflex-based grasping, skilled forelimb reaching, and electrodiagnostic evaluation for comprehensive analysis of functional recovery-The 7-mm rat median nerve gap repair model revisited.
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Brain Behav. 2017 Sep 6;7(10):e00813. doi: 10.1002/brb3.813. eCollection 2017 Oct.
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