机构地区：[1]Department of Internal Medicine,Hanyang University College of Medicine,Seoul 04763,South Korea [2]Department of Internal Medicine,Korea University Anam Hospital,Seoul 02841,South Korea [3]Department of Internal Medicine,The Catholic University of Korea,Yeouido ST.Mary’s Hospital,Seoul 07260,South Korea [4]Department of Internal Medicine,Kyungpook National University Hospital,Daegu 41944,South Korea [5]Department of Internal Medicine,Korea University Ansan Hospital,Ansan-si 15355,South Korea [6]Department of Internal Medicine,Keimyung University Dongsan Hospital,Daegu 42601,South Korea [7]Department of Internal Medicine,Seoul Metropolitan Government Seoul National University Boramae Medical Center,Seoul 07061,South Korea [8]Department of Internal Medicine,Wonkwang University Hospital,Iksan 54538,South Korea [9]Department of Internal Medicine,KyungHee University Medical Center,Seoul 02447,South Korea [10]Department of Internal Medicine,Pusan National University School of Medicine and Biomedical Research Institute,Pusan National University Hospital,Busan 47241,South Korea [11]Department of Internal Medicine,KKonkuk University Medical Center,Seoul 05030,South Korea [12]Department of Internal Medicine,Kosin University Gaspel Hospital,Busan 49267,South Korea [13]Department of Internal Medicine,Daegu Catholic University Medical Center,Daegu 42471,South Korea [14]Department of Internal Medicine,Seoul National University Bundang Hospital,Seongnam-si 13620,Gyeonggi-do,South Korea [15]Department of Internal Medicine,Samsung Medical Center,Seoul 06351,South Korea [16]Department of Internal Medicine,Chonbuk National University Hospital,Jeonju-si 54907,South Korea [17]Department of Internal Medicine,Chonnam National University Hospital,Gwangju 61469,South Korea [18]Department of Internal medicine,Chungbuk National University School of Medicine,Cheong Ju 28644,South Korea [19]Department of Internal Medicine,Severance Hospital,Seoul 03722,South Korea [20]Department of Internal Medicine,The Catholic University of Korea,Seoul
出 处：《World Journal of Gastroenterology》2022年第44期6294-6309,共16页世界胃肠病学杂志（英文版）
基 金：This study is registered at ClinicalTrials.gov.The registration identification number is NCT03736369。
摘 要：BACKGROUND Fexuprazan,a novel potassium-competitive acid blocker,reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells.Fexuprazan’s suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner.AIM To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis(EE).METHODS Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks.The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8.The secondary endpoints included the healing rate of EE at week 4,symptom response,and quality of life assessment.Safety profiles and serum gastrin levels were compared between the groups.RESULTS Of the 263 randomized,218 completed the study per protocol(fexuprazan 40 mg,n=107;esomeprazole 40 mg,n=111).Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8[99.1%(106/107)vs 99.1%(110/111)].There were no between-group differences in the EE healing rate at week 4[90.3%(93/103)vs 88.5%(92/104)],symptom responses,and quality of life assessments.Additionally,serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups.CONCLUSION Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8.We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.
关 键 词：Gastroesophageal reflux ESOPHAGITIS Proton pump inhibitors HEARTBURN Quality of life
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