Salaroli Roberta, Ventrella Domenico, Bernardini Chiara, Elmi Alberto, Zannoni Augusta, Bacci Maria Laura, Forni Monica, Calanni Fiorella, Ferrieri Antonella, Baldi Fabio
Department of Veterinary Medical Science, University of Bologna, Ozzano Emilia, Bologna, Italy.
Health Sciences and Technologies Interdepartmental Center for Industrial Research, University of Bologna, Bologna, Italy.
Clin Exp Gastroenterol. 2020 Nov 13;13:569-576. doi: 10.2147/CEG.S269568. eCollection 2020.
AL2106 is a new medical device based on a mixture of chondroitin sulphate in a xyloglucan and glycerol solution made to maximize its bioadhesive capability to the esophageal mucosa. The aim of the present study was twofold to evaluate the AL2106 protective effect on the esophageal mucosa when exposed to an acidic solution mimicking gastric reflux and to assess the resilience of this effect to saline washing.
A porcine ex vivo model was used and the effects of the new medical device were compared to a sodium alginate suspension (SAS) already present on the market which was assumed as reference. Mucosal damage was induced in 19 porcine esophagi by perfusion with an acidic solution added with pepsin, and Evans blue dye (EBD) tissue uptake was used as an indicator of mucosal permeability. The EBD penetration, expressed as EBD µg/g of dry tissue, was assessed in specimens of untreated damaged mucosa and in specimens treated with AL2106 or SAS. The same evaluation was carried out after washing with normal saline.
Both topical agents tested significantly reduced the EBD uptake by more than 60% (AL2106 8.4±4.5, SAS 3.6±2.7 vs control 23.2±13.1, p<0.01). The saline washing did not cause any significant reduction in the protective effect of AL2106 (8.6±5.9), while it significantly reduced that of SAS (5.9±4.3, p<0.05).
The new AL2106 medical device showed a good barrier effect against a reflux-like damaging solution and preserved this effect after the mucosal washing test, thus suggesting its possible relevance for the treatment of gastroesophageal reflux disease.
AL2106是一种新型医疗设备，它基于硫酸软骨素在木葡聚糖和甘油溶液中的混合物制成，旨在最大程度地提高其对食管黏膜的生物粘附能力。本研究的目的有两个，一是评估AL2106在暴露于模拟胃反流的酸性溶液时对食管黏膜的保护作用，二是评估这种作用对盐水冲洗的恢复能力。
使用猪离体模型，将这种新型医疗设备的效果与市场上已有的海藻酸钠悬浮液（SAS）进行比较，后者被用作对照。通过灌注添加了胃蛋白酶的酸性溶液，在19头猪的食管中诱导黏膜损伤，并使用伊文思蓝染料（EBD）组织摄取量作为黏膜通透性的指标。在未处理的受损黏膜标本以及用AL2106或SAS处理的标本中，评估以每克干组织中EBD微克数表示的EBD渗透情况。在用生理盐水冲洗后进行同样的评估。
所测试的两种局部用药均使EBD摄取量显著降低超过60%（AL2106为8.4±4.5，SAS为3.6±2.7，而对照组为23.2±13.1，p<0.01）。盐水冲洗并未使AL2106的保护作用出现任何显著降低（8.6±5.9），而SAS的保护作用则显著降低（5.9±4.3，p<0.05）。
新型AL2106医疗设备对类似反流的损伤性溶液显示出良好的屏障作用，并且在黏膜冲洗试验后仍保留这种作用，因此表明其在治疗胃食管反流病方面可能具有相关性。
