PDF(Pubmed)
Abstract：
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA. However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
摘要：
■H2受体拮抗剂(H2RA)已用于通过抑制胃酸来治疗胃炎。质子泵抑制剂(PPIs)是比H2RA更有效的酸抑制剂。然而,低剂量PPI治疗胃炎的疗效和安全性尚不清楚.目的探讨小剂量PPI治疗胃炎的疗效和安全性。
■双盲，非自卑，多中心，3期临床试验将476例内镜下糜烂性胃炎患者随机分为一组,一组每天服用埃索美拉唑10mg(DW1903),一组每天服用法莫替丁20mg(DW1903R1),共2周.完整分析集包括319例患者（DW1903，n=159；DW1903R1，n=160），符合方案集包括298例患者（DW1903，n=147；DW1903R1，n=151）。主要终点（侵蚀改善率）和次要终点（侵蚀和水肿治愈率，出血的改善率，红斑,和症状）在治疗后进行评估。比较不良事件。
■根据完整的分析集，DW1903和DW1903R1组的侵蚀改善率分别为59.8%和58.8%，分别。根据符合协议的分析，DW1903和DW1903R1组的侵蚀改善率分别为61.9%和59.6%，分别。除了DW1903的出血改善率更高，两组之间的次要终点没有显着差异，具有统计学趋势。不良事件的数量没有统计学差异。
■低剂量PPI的DW1903不亚于H2RA的DW1903R1。因此，低剂量PPI可能是治疗胃炎的新选择（ClinicalTrials.gov标识符：NCT05163756）。
■双盲，非自卑，多中心，3期临床试验将476例内镜下糜烂性胃炎患者随机分为一组,一组每天服用埃索美拉唑10mg(DW1903),一组每天服用法莫替丁20mg(DW1903R1),共2周.完整分析集包括319例患者（DW1903，n=159；DW1903R1，n=160），符合方案集包括298例患者（DW1903，n=147；DW1903R1，n=151）。主要终点（侵蚀改善率）和次要终点（侵蚀和水肿治愈率，出血的改善率，红斑,和症状）在治疗后进行评估。比较不良事件。
■根据完整的分析集，DW1903和DW1903R1组的侵蚀改善率分别为59.8%和58.8%，分别。根据符合协议的分析，DW1903和DW1903R1组的侵蚀改善率分别为61.9%和59.6%，分别。除了DW1903的出血改善率更高，两组之间的次要终点没有显着差异，具有统计学趋势。不良事件的数量没有统计学差异。
■低剂量PPI的DW1903不亚于H2RA的DW1903R1。因此，低剂量PPI可能是治疗胃炎的新选择（ClinicalTrials.gov标识符：NCT05163756）。
