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病例报告:冻干人羊膜同种异体移植治疗慢性伤口:一项多中心观察性研究的结果

Case Report: Freeze-Dried Human Amniotic Membrane Allograft for the Treatment of Chronic Wounds: Results of a Multicentre Observational Study.

作者信息

Schmiedova Iveta, Ozanova Zuzana, Stastna Elen, Kiselakova Ludmila, Lipovy Bretislav, Forostyak Serhiy

机构信息

PrimeCell Bioscience Inc., Ostrava, Czechia.

BioHealing, Brno, Czechia.

出版信息

Front Bioeng Biotechnol. 2021 Jun 24;9:649446. doi: 10.3389/fbioe.2021.649446. eCollection 2021.

Abstract

An inability of the human body to heal acute wounds under certain conditions results in the formation of chronic ulcers. Chronic wounds not only cause significant pain and discomfort for patients but also serve as an entry for microorganisms into the human body, which can result in serious life-threatening problems and become a significant burden for the patients and society. The current work present results of a multicentre prospective observational study demonstrating the use of a lyophilized amniotic membrane (AM) in the treatment of chronic wounds (various etiologies). Lyophilized AM produced under the commercial brand Amnioderm® was used as an allograft material for therapy of chronic wounds, in addition to chronic ulcer standard-of-care (SoC) protocols. The duration of wounds considered for the application of AM ranged between 2 months and 11 years. In total, 16 patients were enrolled to the study, of which eight were completely healed, six demonstrated a significantly reduced ulcer size, and two did not respond to the AM therapy. The current study unambiguously demonstrates an effective alternative to the standard of chronic wound care and confirms a significant effect of the AM application for chronic wound management as a new SoC.

摘要

人体在某些情况下无法愈合急性伤口会导致慢性溃疡的形成。慢性伤口不仅会给患者带来巨大的疼痛和不适,还会成为微生物进入人体的入口,这可能导致严重的危及生命的问题,并成为患者和社会的重大负担。目前的研究展示了一项多中心前瞻性观察研究的结果,该研究证明了冻干羊膜(AM)在治疗慢性伤口(各种病因)中的应用。除了慢性溃疡标准治疗(SoC)方案外,以商品名Amnioderm®生产的冻干羊膜被用作同种异体移植材料用于治疗慢性伤口。考虑应用AM的伤口持续时间在2个月至11年之间。共有16名患者参与了该研究,其中8名完全愈合,6名溃疡大小显著减小,2名对AM治疗无反应。当前研究明确证明了慢性伤口护理标准的一种有效替代方法,并证实了AM作为一种新的SoC应用于慢性伤口管理的显著效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acc7/8264202/726ef7584f50/fbioe-09-649446-g0001.jpg

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