Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Helicobacter. 2024 Nov-Dec;29(6):e13150. doi: 10.1111/hel.13150.
Given the increasing antibiotic resistance and the inadequate acid-suppressing effects of proton pump inhibitors (PPIs), it is crucial to continuously optimize existing Helicobacter pylori (H. pylori) treatment regimens. This study aimed to evaluate the clinical efficacy and safety of novel potassium-competitive acid blocker (P-CAB)-based eradication regimens compared with traditional PPI-based regimens for the initial treatment of H. pylori.
We conducted a systematic review and network meta-analysis, searching seven electronic databases for randomized controlled trials (RCTs) evaluating initial P-CAB-based H. pylori eradication therapy. The primary outcome was the H. pylori eradication rate. Secondary outcomes included adverse events and patient compliance. We synthesized the effect sizes of the trials using odds ratios (OR) and 95% confidence intervals (95% CI).
A total of 54 RCTs involving 15,320 patients (74.9% male, mean age 30.2 years) were included in this study. In the intention-to-treat (ITT) analysis, VPZ-HD-dual, VPZ-triple, and VPZ-quadruple regimens demonstrated significantly higher eradication rates than PPI-triple, PPI-quadruple, and VPZ-dual regimens. Similar trends were observed in the per-protocol (PP) analysis. Subgroup analysis indicated that poor patient compliance significantly reduced eradication rates. Resistance to clarithromycin and metronidazole significantly weakened the eradication effects of PPI-triple, TPZ-triple, and VPZ-triple regimens. Additionally, the eradication rates for 7-day regimens were significantly lower than those for 14-day or 10-day regimens, but there was no significant difference between the eradication rates of 10-day and 14-day regimens. Notably, the risk of adverse events with VPZ-HD-dual was significantly lower than with VPZ-quadruple.
Vonoprazan combined with high-dose amoxicillin dual therapy not only provides satisfactory eradication rates but also exhibits lower adverse event rates and good patient compliance, indicating its potential as a promising regimen for further promotion.
鉴于抗生素耐药性的增加和质子泵抑制剂 (PPI) 的抑酸作用不足,不断优化现有的幽门螺杆菌 (H. pylori) 治疗方案至关重要。本研究旨在评估新型钾竞争性酸阻滞剂 (P-CAB) 为基础的根除方案与传统 PPI 为基础的方案在初始治疗 H. pylori 方面的临床疗效和安全性。
我们进行了系统评价和网络荟萃分析,在七个电子数据库中搜索评估初始 P-CAB 为基础的 H. pylori 根除治疗的随机对照试验 (RCT)。主要结局是 H. pylori 根除率。次要结局包括不良事件和患者依从性。我们使用比值比 (OR) 和 95%置信区间 (95%CI) 综合试验的效应大小。
共有 54 项 RCT 纳入 15320 例患者(74.9%为男性,平均年龄 30.2 岁)。在意向治疗 (ITT) 分析中,VPZ-HD-双联、VPZ-三联和 VPZ-四联方案的根除率明显高于 PPI-三联、PPI-四联和 VPZ-双联方案。在按方案 (PP) 分析中也观察到类似的趋势。亚组分析表明,患者依从性差显著降低了根除率。克拉霉素和甲硝唑耐药显著削弱了 PPI-三联、TPZ-三联和 VPZ-三联方案的根除效果。此外,7 天方案的根除率明显低于 14 天或 10 天方案,但 10 天和 14 天方案的根除率之间无显著差异。值得注意的是,VPZ-HD-双联的不良反应风险明显低于 VPZ-四联。
沃诺拉赞联合高剂量阿莫西林双联治疗不仅提供了令人满意的根除率,而且不良反应发生率较低,患者依从性较好,表明其作为一种有前途的方案有进一步推广的潜力。