Spada Cristiano, Salvi Daniele, Pecere Silvia, Mangiola Francesca, Varca Simone, Rosu Serban, Prateek Vora, Ciobanca Petru Vasile, Goldis Adrian, Barattini Dionisio Franco, Costamagna Guido
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.
Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
J Clin Med. 2025 Jul 7;14(13):4794. doi: 10.3390/jcm14134794.
: Up to one-third of patients with gastroesophageal reflux disease (GERD) have persistent symptoms despite proton-pump inhibitor (PPI) therapy. E-Gastryal + MgAlg (Aurora Biofarma, Italy) is a mucosal protective agent that enhances barrier function against acid and non-acidic reflux. This study assessed its efficacy in combination with omeprazole versus omeprazole alone and as maintenance therapy. : Patients with symptomatic GERD and Grade A reflux esophagitis confirmed by endoscopy were randomized to receive omeprazole 20 mg plus E-Gastryal + MgAlg or omeprazole 20 mg alone. The primary endpoint was the number of rescue medications used over 28 days. Secondary endpoints included symptom relief and quality-of-life assessments using the Reflux Symptom Index (RSI), Gastroesophageal Reflux Disease Impact Scale (GIS), GERD-Health-Related Quality of Life (GERD-HRQL), and Global Assessment of Performance (IGAP). : Ninety-six patients were included. The combination group used significantly fewer rescue medications (mean: 21 vs. 40.9 tablets; = 0.002). At week 4, the combination group showed greater improvement in RSI, GIS, and GERD-HRQL scores ( < 0.001). Symptom relief was sustained during weeks 5-26 with E-Gastryal + MgAlg alone. : E-Gastryal + MgAlg combined with omeprazole improves symptom control compared to PPI monotherapy. Continued use as maintenance therapy supports its role in long-term GERD management (NCT04130659).
高达三分之一的胃食管反流病(GERD)患者尽管接受了质子泵抑制剂(PPI)治疗,但仍有持续症状。E-Gastryal + MgAlg(意大利奥罗拉生物制药公司)是一种粘膜保护剂,可增强对酸性和非酸性反流的屏障功能。本研究评估了其与奥美拉唑联合使用相对于单独使用奥美拉唑的疗效以及作为维持治疗的效果。:有症状的GERD且经内镜检查确诊为A级反流性食管炎的患者被随机分为接受20 mg奥美拉唑加E-Gastryal + MgAlg或单独接受20 mg奥美拉唑治疗。主要终点是28天内使用的急救药物数量。次要终点包括使用反流症状指数(RSI)、胃食管反流病影响量表(GIS)、GERD健康相关生活质量(GERD-HRQL)和整体表现评估(IGAP)进行的症状缓解和生活质量评估。:纳入了96名患者。联合治疗组使用的急救药物明显较少(平均:21片对40.9片;P = 0.002)。在第4周时,联合治疗组在RSI、GIS和GERD-HRQL评分方面有更大改善(P < 0.001)。仅使用E-Gastryal + MgAlg时,症状缓解在第5至26周持续存在。:与PPI单药治疗相比,E-Gastryal + MgAlg联合奥美拉唑可改善症状控制。持续作为维持治疗支持其在GERD长期管理中的作用(NCT04130659)。