BACKGROUND For the treatment of gastritis,rebamipide,a mucoprotective agent,and nizatidine,a gastric acid suppressant,are commonly employed individually.AIM To compare the efficacy of Mucotra®SR(rebamipide 150 mg...BACKGROUND For the treatment of gastritis,rebamipide,a mucoprotective agent,and nizatidine,a gastric acid suppressant,are commonly employed individually.AIM To compare the efficacy of Mucotra®SR(rebamipide 150 mg)and Axid®(nizatidine 150 mg)combination therapy with the sole administration of Axid®in managing erosive gastritis.METHODS A total of 260 patients diagnosed with endoscopically confirmed erosive gastritis were enrolled in this open-label,multicenter,randomized,phase 4 clinical trial,allocating them into two groups:Rebamipide/nizatidine combination twice daily vs nizatidine twice daily for 2 weeks.The full-analysis set analysis encompassed 239 patients(rebamipide/nizatidine,n=121;nizatidine,n=118),while the per-protocol analysis included 218 patients(n=110 vs 108).Post-treatment assessments comprised primary(erosion improvement rate)and secondary(erosion and edema cure rates,erythema improvement rates,hemorrhage,and gastrointestinal symptoms)endpoints.Furthermore,drug-related adverse effects were evaluated.RESULTS Primary efficacy assessment showed a statistically significant improvement rate in mucosal erosions in the combination group compared to the control group in the full-analysis set(rebamipide/nizatidine 62.0%,nizatidine 49.2%,P=0.046),with a similar trend noted in the per-protocol analysis(62.7%vs 50.0%,P=0.058).Both groups were effective in curing erosion and edema and improvement of bleeding,erythema,and gastrointestinal symptoms,whereas no inter-group differences were noted.When confined to the participants with gastritis symptoms,improvement of erosion was more optimal in the combination group(63.0%vs 49.5%,P=0.046).No adverse events related to the drugs were observed.CONCLUSION Rebamipide/nizatidine combination is effective in treatment of erosive gastritis.展开更多
文摘BACKGROUND For the treatment of gastritis,rebamipide,a mucoprotective agent,and nizatidine,a gastric acid suppressant,are commonly employed individually.AIM To compare the efficacy of Mucotra®SR(rebamipide 150 mg)and Axid®(nizatidine 150 mg)combination therapy with the sole administration of Axid®in managing erosive gastritis.METHODS A total of 260 patients diagnosed with endoscopically confirmed erosive gastritis were enrolled in this open-label,multicenter,randomized,phase 4 clinical trial,allocating them into two groups:Rebamipide/nizatidine combination twice daily vs nizatidine twice daily for 2 weeks.The full-analysis set analysis encompassed 239 patients(rebamipide/nizatidine,n=121;nizatidine,n=118),while the per-protocol analysis included 218 patients(n=110 vs 108).Post-treatment assessments comprised primary(erosion improvement rate)and secondary(erosion and edema cure rates,erythema improvement rates,hemorrhage,and gastrointestinal symptoms)endpoints.Furthermore,drug-related adverse effects were evaluated.RESULTS Primary efficacy assessment showed a statistically significant improvement rate in mucosal erosions in the combination group compared to the control group in the full-analysis set(rebamipide/nizatidine 62.0%,nizatidine 49.2%,P=0.046),with a similar trend noted in the per-protocol analysis(62.7%vs 50.0%,P=0.058).Both groups were effective in curing erosion and edema and improvement of bleeding,erythema,and gastrointestinal symptoms,whereas no inter-group differences were noted.When confined to the participants with gastritis symptoms,improvement of erosion was more optimal in the combination group(63.0%vs 49.5%,P=0.046).No adverse events related to the drugs were observed.CONCLUSION Rebamipide/nizatidine combination is effective in treatment of erosive gastritis.
