Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan, China.
Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin Institute of Digestive Disease, Tianjin Key Laboratory of Digestive Diseases, Tianjin, China.
Medicine (Baltimore). 2024 Oct 18;103(42):e40170. doi: 10.1097/MD.0000000000040170.
Vonoprazan (VPZ) has been shown to have superior acid-inhibitory effects compared to proton pump inhibitors (PPIs). However, there is a paucity of research examining the efficacy of vonoprazan-based bismuth quadruple therapy (VBQT) in the eradication of primary Helicobacter pylori infection. This study aimed to evaluate the effectiveness and safety of VBQT as a first-line treatment for H pylori eradication. This retrospective, real-world, single-arm study included consecutive treatment-naive patients who received VBQT (VPZ 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth potassium citrate 220 mg, all administered twice daily for 14 days) for H pylori eradication between March 1, 2021, and May 30, 2023. The study included both outpatients and inpatients. Eradication rates were assessed using 13C-urea breath tests or 14C-urea breath tests performed 4 to 6 weeks after treatment. The primary outcomes included eradication rates, adverse events, and treatment compliance. A total of 612 H pylori-infected patients were included in the study. The intention-to-treat (ITT), modified ITT (MITT), and per-protocol analyses showed H pylori eradication rates of 84.3% (95% CI: 812% to 87.1%), 95.9% (95% CI: 93.9% to 97.4%), and 96.4% (95% CI: 94.4% to 97.8%), respectively. In the ITT analysis, the adverse event rate was 12.7%, and the treatment compliance rate was 96.9%. In real-world practice, the VBQT regimen demonstrates excellent efficacy and favorable tolerability as a first-line therapy for H pylori eradication.
沃诺拉赞（VPZ）与质子泵抑制剂（PPIs）相比具有更好的抑酸效果。然而，目前关于基于沃诺拉赞的铋四联疗法（VBQT）在根除原发性幽门螺杆菌感染方面的疗效研究较少。本研究旨在评估 VBQT 作为 H pylori 根除的一线治疗方案的有效性和安全性。这项回顾性、真实世界、单臂研究纳入了 2021 年 3 月 1 日至 2023 年 5 月 30 日期间接受 VBQT（VPZ 20mg、阿莫西林 1000mg、克拉霉素 500mg、枸橼酸铋钾 220mg，均每日 2 次，持续 14 天）治疗的初治、连续的 H pylori 感染患者。研究包括门诊和住院患者。治疗结束后 4 至 6 周，采用 13C-尿素呼气试验或 14C-尿素呼气试验评估根除率。主要结局包括根除率、不良事件和治疗依从性。共有 612 例 H pylori 感染患者纳入本研究。意向治疗（ITT）、改良意向治疗（MITT）和符合方案分析显示，H pylori 根除率分别为 84.3%（95%CI：81.2%至 87.1%）、95.9%（95%CI：93.9%至 97.4%）和 96.4%（95%CI：94.4%至 97.8%）。在 ITT 分析中，不良事件发生率为 12.7%，治疗依从率为 96.9%。在真实世界实践中，VBQT 方案作为 H pylori 根除的一线治疗方案，具有优异的疗效和良好的耐受性。
