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海藻酸钠黏膜下注射溶液用于猪模型内镜切除的疗效和安全性。

Efficacy and safety of a submucosal injection solution of sodium alginate for endoscopic resection in a porcine model.

机构信息

Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.

Research and Development Center of Mcnulty Pharma Co., Ltd., Seoul, Republic of Korea.

出版信息

Sci Rep. 2024 Feb 26;14(1):4592. doi: 10.1038/s41598-024-55226-y.

Abstract

Endoscopic resection techniques require the use of submucosal injection. Normal saline and sodium hyaluronate solutions are mainly used for this purpose, but an ideal solution has not yet been developed. The aim of this study was to assess a new solution, MC-003-a novel submucosal injection solution developed with sodium alginate as the main ingredient. Normal saline, a commercial sodium hyaluronate solution (Endo-Ease), and MC-003 were examined. A total of 18 gastric submucosal cushions were created in the stomachs of six pigs. The height of mucosal elevation was measured sequentially using endoscopic sonography. After euthanizing the animals either 2 h or 5 days after the procedure, pathologic examination was performed for each injection site. Although not statistically significant over the entire study period, MC-003 showed a superior result to normal saline and an equivalent result to Endo-Ease in the submucosal cushion height and its rate of decrease. There were no adverse outcomes after injection of the three solutions and there was no pathologically identified detrimental change in the resected specimens. MC-003 creates a sufficient submucosal fluid cushion without apparent tissue damage. It can be considered as an effective submucosal injection material.

摘要

内镜下切除技术需要使用黏膜下注射。生理盐水和透明质酸钠溶液主要用于此目的,但尚未开发出理想的溶液。本研究旨在评估一种新的溶液,即 MC-003,这是一种以海藻酸钠为主要成分开发的新型黏膜下注射溶液。研究比较了生理盐水、一种商业透明质酸钠溶液(Endo-Ease)和 MC-003。在 6 头猪的胃中总共创建了 18 个胃黏膜下垫。使用内镜超声连续测量黏膜抬高的高度。在手术 2 小时或 5 天后对动物实施安乐死,对每个注射部位进行病理检查。尽管在整个研究期间没有统计学意义,但 MC-003 在黏膜下垫高度及其降低率方面的效果优于生理盐水,与 Endo-Ease 相当。三种溶液注射后均无不良后果,且切除标本无病理确认的有害变化。MC-003 可产生足够的黏膜下液垫,且无明显的组织损伤。它可以被认为是一种有效的黏膜下注射材料。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea34/10897473/6aaeb44ac9ff/41598_2024_55226_Fig1_HTML.jpg

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