Romano Claudio, Scarpignato Carmelo
Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Messina, Italy.
United Campus of Malta, Msida, Malta.
Therap Adv Gastroenterol. 2022 Aug 17;15:17562848221115319. doi: 10.1177/17562848221115319. eCollection 2022.
Gastroesophageal reflux disease (GERD) is still a challenging and difficult to treat condition in children. Although acid suppression represents the mainstay of treatment in adolescents, it is not devoid of adverse events, especially in the long-term.
In this investigation we explored a new therapeutic avenue in GERD, that is esophageal mucosal protection.
To this end, we performed an investigator-initiated, retrospective study to evaluate the efficacy and safety of a short-term treatment with Esoxx™ medical device in 25 adolescents with GERD-related symptoms. This mucoadhesive formulation contains two natural mucopolysaccharides (sodium hyaluronate and chondroitin sulphate) and adheres to the esophageal mucosa, exerting a protective effect against refluxed gastric contents and allowing mucosal healing.
Heartburn, epigastric burning and post-prandial regurgitation were scored with a pain VAS scale and re-evaluated after 3-week treatment with Esoxx (one stick post-prandially, three times daily).
All patients completed the treatment without adverse effects and with good tolerability and compliance. All the three major symptoms significantly (p<0.001) improved after treatment. No patient required additional investigation (i.e. upper Gastrointestinal endoscopy) or medication (i.e. antisecretory drugs).
The results of this pilot study suggest that esophageal mucosal protection is a promising therapeutic avenue for GERD also in children. Provided, these data be confirmed by a large, randomized clinical trial, this medical device can enter our therapeutic armamentarium against this challenging disease.
胃食管反流病(GERD)在儿童中仍然是一种具有挑战性且难以治疗的疾病。尽管抑酸是青少年治疗的主要手段,但并非没有不良事件,尤其是长期来看。
在本研究中,我们探索了一种治疗GERD的新途径,即食管黏膜保护。
为此,我们开展了一项研究者发起的回顾性研究,以评估Esoxx™医疗器械对25名有GERD相关症状的青少年进行短期治疗的疗效和安全性。这种黏膜黏附制剂含有两种天然黏多糖(透明质酸钠和硫酸软骨素),可黏附于食管黏膜,对反流的胃内容物发挥保护作用并促进黏膜愈合。
采用疼痛视觉模拟量表(VAS)对烧心、上腹部烧灼感和餐后反流进行评分,并在使用Esoxx进行3周治疗后(餐后1支,每日3次)重新评估。
所有患者均完成治疗,无不良反应,耐受性和依从性良好。治疗后所有三种主要症状均显著改善(p<0.001)。无需额外检查(即上消化道内镜检查)或用药(即抗分泌药物)。
这项初步研究的结果表明,食管黏膜保护对于儿童GERD也是一种有前景的治疗途径。如果这些数据能得到大型随机临床试验的证实,这种医疗器械可纳入我们针对这种具有挑战性疾病的治疗手段。