Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Department of Gastroenterology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.
Int J Antimicrob Agents. 2024 Nov;64(5):107320. doi: 10.1016/j.ijantimicag.2024.107320. Epub 2024 Sep 16.
Keverprazan is a novel potassium-competitive acid blocker. The advantages of keverprazan as a potent acid suppressor in Helicobacter pylori eradication have not yet been demonstrated. The aim of this study was to evaluate the efficacy of keverprazan as a component of bismuth quadruple therapy in H. pylori treatment.
Adult patients with H. pylori infection were enrolled and randomised to take keverprazan (KEV group)- or esomeprazole (ESO group)-quadruple therapy. The regimens contained keverprazan 20 mg or esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg and bismuth potassium citrate 240 mg and were administered twice daily for 14 days. The primary endpoint was the H. pylori eradication rate at 4 weeks after treatment.
The full analysis set showed that the H. pylori eradication rates were 87.8% (252/287) and 82.52% (236/286) for the KEV and ESO groups, respectively (difference: 5.29%; 95% confidence interval [CI]: -0.55-11.18). Keverprazan was superior to esomeprazole in terms of eradication rate in the per protocol set (P=0.0382). The eradication rates for patients resistant or non-resistant to clarithromycin were both numerically higher in the KEV group than the ESO group (83.45% vs. 76.98% for clarithromycin-resistance; 92.31% vs. 88.16% for clarithromycin-non-resistance). The incidence of adverse events was similar in the KEV and ESO groups (76.31% vs. 77.62%), with most adverse events (>90%) being mild in severity. No TEAEs led to death in either group.
Keverprazan 20 mg twice daily, used as a component of bismuth quadruple therapy, provided effective H. pylori eradication and was non-inferior to an esomeprazole-based regimen.
Keverprazan 是一种新型钾竞争性酸阻滞剂。Keverprazan 作为幽门螺杆菌根除治疗中的强效抑酸剂的优势尚未得到证实。本研究旨在评估 Keverprazan 作为铋四联疗法的一种成分在幽门螺杆菌治疗中的疗效。
招募患有幽门螺杆菌感染的成年患者，并将其随机分为 Keverprazan（KEV 组）或埃索美拉唑（ESO 组）四联疗法组。方案包含 Keverprazan 20mg 或埃索美拉唑 20mg、克拉霉素 500mg、阿莫西林 1000mg 和枸橼酸铋钾 240mg，每日 2 次，共 14 天。主要终点是治疗后 4 周时的幽门螺杆菌根除率。
全分析集显示，KEV 组和 ESO 组的幽门螺杆菌根除率分别为 87.8%（252/287）和 82.52%（236/286）（差异：5.29%；95%置信区间[CI]：-0.55-11.18）。KEV 组在方案人群中的根除率优于埃索美拉唑（P=0.0382）。克拉霉素耐药和非耐药患者的根除率在 KEV 组均高于 ESO 组（克拉霉素耐药：83.45% vs. 76.98%；克拉霉素非耐药：92.31% vs. 88.16%）。KEV 组和 ESO 组不良反应发生率相似（76.31% vs. 77.62%），大多数不良反应（>90%）为轻度。两组均无治疗相关不良事件导致死亡。
Keverprazan 每日 2 次 20mg，作为铋四联疗法的一种成分，可有效根除幽门螺杆菌，且与埃索美拉唑为基础的方案相比非劣效。
