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新型食管炎治疗方法的体外黏附强度和屏障效应评估。

Ex vivo evaluation of adhesive strength and barrier effect of a novel treatment for esophagitis.

机构信息

Instituto Universitario de Investigaciones Biomédicas y Sanitarias, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain; Strategos BioTech SL, Teide, Spain.

Instituto Universitario de Sanidad Animal, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.

出版信息

Gastroenterol Hepatol. 2023 Jun-Jul;46(6):455-461. doi: 10.1016/j.gastrohep.2022.10.013. Epub 2022 Oct 20.

DOI:10.1016/j.gastrohep.2022.10.013
PMID:36273654
Abstract

AIM

To investigate the mucoadhesive strength and barrier effect of Esophacare® (Atika Pharma SL, Las Palmas de Gran Canaria) in an ex vivo model of gastro-oesophageal reflux.

METHODS

An ex vivo evaluation through the Falling Liquide Film Technique with porcine esophagi was performed, compared to a positive control (Ziverel®; Norgine, Amsterdam), after different washing periods with saline, acidified saline (pH 1.2) and acidified saline with pepsin (2000U/mL).

RESULTS

The adhesive mean strength on the oesophageal mucosa of Esophacare was 94.7 (6.0)%, compared to 27.6 (19.1)% of the positive control (p<0.05). These results were homogeneous across the different washes and throughout the tissue. The area covered by 1mL of Esophacare, and its respective persistence after washing was also assessed, yielding a mean global persistence of 74.29 (19.7)% vs. 18.9 (12.3)% for the control (p<0.05). In addition, after 30min exposure to acidified saline with pepsin, Esophacare shows a protective effect on the oesophageal mucosa, detectable histologically: preserved integrity and structure of the apical layers was observed, as well as reduced permeability to the washing solution.

CONCLUSIONS

Esophacare shows an adhesive strength close to 100%, irrespective of the washing solution applied or the oesophageal region studied. Histologically, it reduces the abrasive effects of the acidic solution on the oesophageal epithelium, reducing permeability to the washing solution. The results in this ex vivo model of gastro-oesophageal reflux disease (GERD) support its therapeutic potential.

摘要

目的

在胃食管反流病的体外模型中,研究 Esophacare®(Atika Pharma SL,Las Palmas de Gran Canaria)的黏膜黏附强度和屏障效应。

方法

通过使用猪食管进行液体滑落薄膜技术的体外评估,并与阳性对照(Ziverel®;Norgine,阿姆斯特丹)进行比较,在不同的盐水、酸化盐水(pH 1.2)和含胃蛋白酶的酸化盐水(2000U/mL)冲洗后进行评估。

结果

Esophacare 在食管黏膜上的平均黏附强度为 94.7(6.0)%,而阳性对照为 27.6(19.1)%(p<0.05)。这些结果在不同的冲洗液和整个组织中是一致的。还评估了 1mL Esophacare 覆盖的面积及其在冲洗后的持续时间,结果显示其总持续时间为 74.29(19.7)%,而对照为 18.9(12.3)%(p<0.05)。此外,在酸性含胃蛋白酶盐水暴露 30 分钟后,Esophacare 对食管黏膜显示出保护作用,可通过组织学检测到:观察到顶端层的完整性和结构得到了保留,并且对冲洗溶液的通透性降低。

结论

Esophacare 显示出接近 100%的黏附强度,无论应用的冲洗液或研究的食管区域如何。组织学上,它减少了酸性溶液对食管上皮的磨损作用,降低了对冲洗溶液的通透性。胃食管反流病(GERD)的体外模型的结果支持其治疗潜力。

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