机构地区：[1]Department of Internal Medicine,Seoul St.Mary’s Hospital,The Catholic University of Korea,Seoul 06591,South Korea [2]Department of Internal Medicine,Ewha Womans University Seoul Hospital,Gastroenterology and Hepatology Center,Seoul 07985,South Korea [3]Department of Internal Medicine,Ewha Womans University Mokdong Hospital,Seoul 07985,South Korea [4]Department of Internal Medicine,Kangwon National University School of Medicine,Chuncheon 24289,South Korea [5]Department of Medicine,Kangbuk Samsung Hospital,Sungkyunkwan University School of Medicine,Seoul 03181,South Korea [6]Department of Internal Medicine and Liver Research Institute,Seoul National University Hospital,Seoul 03080,South Korea [7]Department of Internal Medicine,Ilsan Paik Hospital,Inje University College of Medicine,Goyang 10380,South Korea [8]Department of Internal Medicine,Digestive Disease Center,Soonchunhyang University Bucheon Hospital,Bucheon 31538,South Korea [9]Department of Internal Medicine,Inje University College of Medicine,Sanggye Paik Hospital,Seoul 01757,South Korea [10]Department of Gastroenterology,Sahmyook Medical Center,Seoul 02500,South Korea [11]Department of Internal Medicine,Hanyang University College of Medicine,Seoul 04763,South Korea [12]Department of Internal Medicine,Keimyung University School of Medicine,Daegu 42601,South Korea [13]Department of Internal Medicine,Inje University Haeundae Paik Hospital,Inje University College of Medicine,Busan 48108,South Korea [14]Department of Internal Medicine,Gyeongsang National University School of Medicine,Gyeongsang National University Hospital,Jinju 52727,South Korea [15]Department of Internal Medicine,Konyang University Hospital,Daejeon 35365,South Korea [16]Gastroenterology Center,Konkuk University Medical Center,Seoul 05030,South Korea [17]Department of Gastroenterology,Seoul Medical Center,Seoul 02053,South Korea [18]Department of Gastroenterology,Inje University Busan Paik Hospital,Busan 47392,South Korea [19]Department of Gastroenterology,St.Carollo Hospital,Sooncheon 5
出 处：《World Journal of Gastroenterology》2024年第48期5152-5161,共10页世界胃肠病学杂志（英文）
摘 要：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.
关 键 词：GASTRITIS Erosive gastritis Combination therapy REBAMIPIDE NIZATIDINE
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