背景:在根除幽门螺杆菌的双重疗法中使用的阿莫西林剂量在不同的研究中存在差异,并且对于基于vonoprazan的双重疗法的最佳阿莫西林剂量仍不清楚。我们旨在研究低和高剂量阿莫西林在伏诺拉赞-阿莫西林双重治疗中的疗效和安全性。
方法:通过搜索数据库从开始到2023年10月进行了全面的系统评价。包括所有评价沃诺拉赞-阿莫西林双重疗法根除幽门螺杆菌的有效性和安全性的试验。汇集根除率,不良事件的发生率,相对风险,并给出了95%的置信区间。
结果:18项研究包括12个低剂量阿莫西林(VLA)和13个高剂量阿莫西林(VHA)组。VLA治疗的合并根除率分别为82.4%和86.8%,通过意向治疗和符合方案分析,VHA治疗占86.0%和90.9%,分别。在按持续时间分层的亚组分析中,7天内达到的根除率,10天,VLA和VHA双重疗法治疗14天的比例为80.8%,84.2%,83.1%,和67.3%,88.8%,87.5%,分别。在直接比较VLA和VHA双重疗法的四项随机对照试验中,意向治疗的疗效无统计学差异(76.9%vs81.4%,p=0.337)和每个协议(81.6%vs84.0%,p=0.166)分析。此外,两组的不良事件发生率(p=0.965)和依从性(p=0.994)相似.
结论:VLA治疗与VHA治疗具有相当的疗效和安全性,以及地区差异。适当延长的治疗持续时间对于优化vonoprazan-阿莫西林治疗的治疗效果至关重要。
BACKGROUND: The amoxicillin dose used in dual therapy to eradicate Helicobacter pylori varies across studies and the optimal amoxicillin dose for vonoprazan-based dual therapies remains unclear. We aimed to investigate the efficacy and safety of low- and high-dose amoxicillin in vonoprazan-amoxicillin dual therapy.
METHODS: A comprehensive systematic review was conducted by searching databases from inception to October 2023. All trials that evaluated the effectiveness and safety of vonoprazan-amoxicillin dual therapy for eradicating H. pylori were included. Pooled eradication rate, incidence of adverse events, relative risks, and 95% confidence intervals are presented.
RESULTS: Eighteen studies with 12 low-dose amoxicillin (VLA) and 13 high-dose amoxicillin (VHA) arms were included. The pooled eradication rates were 82.4% and 86.8% for VLA therapy, and 86.0% and 90.9% for VHA therapy by the intention-to-treat and per-protocol analyses, respectively. In the subgroup analysis stratified by duration, the eradication rates achieved in 7 days, 10 days, and 14 days treatments with VLA and VHA dual therapies were 80.8%, 84.2%, 83.1%, and 67.3%, 88.8%, 87.5%, respectively. In the four randomized controlled trials that directly compared VLA and VHA dual therapies, the efficacy was not statistically different in the intention-to-treat (76.9% vs 81.4%, p = 0.337) and per-protocol (81.6% vs 84.0%, p = 0.166) analyses. Additionally, the incidence of adverse events (p = 0.965) and compliance (p = 0.994) were similar in both groups.
CONCLUSIONS: VLA therapy demonstrated comparable efficacy and safety to VHA therapy, along with regional differences. An appropriately extended treatment duration may be critical for therapeutic optimization of vonoprazan-amoxicillin treatment.