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 Mar 8;103(10):e37476. doi: 10.1097/MD.0000000000037476.
Vonoprazan, a novel acid suppressant and the first potassium-competitive acid blocker, has the potential to enhance the eradication rate of Helicobacter pylori due to its robust acid-suppressing capacity. This study aimed to compare the efficacy of vonoprazan-based dual therapy (vonoprazan-amoxicillin, VA) with vonoprazan-based bismuth quadruple therapy (VBQT) as a first-line treatment for H pylori infection. This retrospective single-center non-inferiority study was conducted in China. Treatment-naive H pylori-positive patients aged 18 to 80 received one of the 2 treatment regimens at our center. The VA group received vonoprazan 20 mg twice daily and amoxicillin 1000 mg 3 times daily for 14 days, whereas the VBQT group received vonoprazan 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg twice daily for 14 days. The eradication rate was evaluated 4 to 6 weeks after treatment using the carbon-13/14 urea breath test. Propensity score matching was used to analyze eradication rates, adverse events (AEs), and patient compliance between the 2 groups. Initially, 501 patients were included, and after propensity score analysis, 156 patients were selected for the study. Intention-to-treat analysis showed eradication rates of 87.2% (95% CI, 79.8-94.6%) for the VA group and 79.5% (95% CI, 70.5-88.4%) for the VBQT group (P = .195). Per-protocol analysis demonstrated rates of 94.4% (95% CI, 89.2-99.7%) for the VA group and 96.8% (95% CI, 92.4-100%) for the VBQT group (P = .507). Non-inferiority was confirmed between the 2 groups, with P values < .025. The VA group showed a lower rate of AEs (10.3% vs 17.9%, P = .250) compared to the VBQT group. There were no significant differences in patient compliance between the 2 groups. In treatment-naive patients with H pylori infection, both the 14-day VA and VBQT regimens demonstrated comparable efficacy, with excellent eradication rates. Moreover, due to reduced antibiotic usage, lower rate of AEs, and lower costs, VA dual therapy should be prioritized.
沃诺拉赞是一种新型抑酸剂,也是首个钾竞争性酸阻滞剂,因其强大的抑酸能力,有望提高幽门螺杆菌的根除率。本研究旨在比较沃诺拉赞为基础的双联疗法(沃诺拉赞-阿莫西林,VA)与沃诺拉赞为基础的铋四联疗法(VBQT)作为幽门螺杆菌感染一线治疗的疗效。这是一项在中国进行的回顾性单中心非劣效性研究。在本中心,治疗初治的幽门螺杆菌阳性的 18-80 岁患者接受了其中 2 种治疗方案之一。VA 组接受沃诺拉赞 20mg,每日 2 次,阿莫西林 1000mg,每日 3 次,共 14 天;VBQT 组接受沃诺拉赞 20mg、阿莫西林 1000mg、克拉霉素 500mg 和枸橼酸铋钾 220mg,每日 2 次,共 14 天。治疗后 4-6 周,采用碳-13/14 尿素呼气试验评估根除率。采用倾向性评分匹配分析两组的根除率、不良事件(AE)和患者依从性。最初纳入了 501 例患者,经倾向性评分分析后,156 例患者被纳入研究。意向治疗分析显示,VA 组的根除率为 87.2%(95%CI,79.8-94.6%),VBQT 组为 79.5%(95%CI,70.5-88.4%)(P=0.195)。基于方案的分析显示,VA 组的根除率为 94.4%(95%CI,89.2-99.7%),VBQT 组为 96.8%(95%CI,92.4-100%)(P=0.507)。两组之间证实了非劣效性,P 值均<0.025。VA 组的 AE 发生率(10.3%比 17.9%,P=0.250)低于 VBQT 组。两组患者的依从性无显著差异。在初治的幽门螺杆菌感染患者中,14 天的 VA 和 VBQT 方案均显示出相当的疗效,根除率高。此外,由于抗生素使用减少、AE 发生率降低和成本降低,VA 双联疗法应作为优先选择。