Department of Medicine, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Hong Kong.
Helicobacter. 2024 Sep-Oct;29(5):e13133. doi: 10.1111/hel.13133.
BACKGROUND: We compared efficacy of vonoprazan-dual or triple therapies and bismuth-quadruple therapy for treatment-naive Helicobacter pylori (HP) infection in Southern China, where primary resistance rates of clarithromycin and levofloxacin are >30%. METHODS: This was an investigator-initiated, three-arm, randomized clinical trial in Southern China. Between March 2022 and August 2023, treatment-naïve HP-infected adults were randomly assigned to receive one of three 14-day regimens (1:1:1 ratio): vonoprazan-dual (VA-dual; vonoprazan 20 mg twice daily and amoxicillin 1 g thrice daily), vonoprazan-triple (VAC-triple; vonoprazan 20 mg/amoxicillin 1 g/clarithromycin 500 mg twice daily), or bismuth-quadruple therapy containing bismuth, esomeprazole, tetracycline, and metronidazole. Primary outcome was noninferiority in HP eradication, evaluated by UBT 4-6 weeks post-treatment by intention-to-treat (ITT) and per-protocol (PP) analysis (based on subjects who completed 14-day treatment and rechecked UBT). Bonferroni-adjusted p-value of <0.017 was used to determine statistical significance. RESULTS: A total of 298 subjects (mean age: 35.7 ± 8.4 years; male: 134 [45.0%]; VC-dual: 100, VAC-triple: 98, bismuth-quadruple: 100) were enrolled, and 292 (98.0%) had UBT rechecked. ITT analysis showed that both VA-dual (eradication rate of 96.0%) and VAC-triple therapies (95.9%) were noninferior to bismuth-quadruple therapy (92.0%) (difference: 4.0%, 95% CI: -2.9% to 11.5%, p < 0.001; and 3.9%, 95% CI: -3.1% to 11.5%, p < 0.001, respectively). PP analysis also revealed noninferiority (96.7% or 96.7% vs. 97.4%, with difference: -2.9% and -2.9%, p = 0.009 and 0.010, respectively). The frequency of adverse events was 39.0%, 56.1%, and 71.0% in VA-dual, VAC-triple, and bismuth-quadruple therapies, respectively. CONCLUSIONS: VA-dual and VA-triple therapies are highly effective and noninferior to bismuth-quadruple therapy in Southern China. Given the lower adverse effects and fewer antibiotic use, VA-dual therapy is the preferred first-line treatment for HP infection. TRIAL REGISTRATION: Chinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, https://www.chictr.org.cn/showproj.aspx?proj=14131.
背景：我们比较了沃诺拉赞双联或三联疗法与铋四联疗法治疗中国南方初治幽门螺杆菌（HP）感染的疗效，该地区克拉霉素和左氧氟沙星的原发耐药率均>30%。
方法：这是一项在中国南方进行的、由研究者发起的、三臂、随机临床试验。2022 年 3 月至 2023 年 8 月，初治 HP 感染的成年患者被随机分配接受三种 14 天方案之一（1:1:1 比例）：沃诺拉赞双联（VA-双联；沃诺拉赞 20mg，每日两次，阿莫西林 1g，每日三次）、沃诺拉赞三联（VAC-三联；沃诺拉赞 20mg/阿莫西林 1g/克拉霉素 500mg，每日两次）或铋四联疗法，包含铋剂、艾司奥美拉唑、四环素和甲硝唑。主要结局是通过 UBT 在治疗后 4-6 周进行的非劣效性评估，采用意向治疗（ITT）和符合方案（PP）分析（基于完成 14 天治疗并重新检查 UBT 的受试者）。Bonferroni 调整的<0.017 的 p 值用于确定统计学意义。
结果：共纳入 298 名受试者（平均年龄：35.7±8.4 岁；男性：134[45.0%]；VA-双联：100 名，VAC-三联：98 名，铋四联：100 名），292 名（98.0%）接受了 UBT 复查。ITT 分析显示，VA-双联（96.0%）和 VAC-三联疗法（95.9%）均非劣效于铋四联疗法（92.0%）（差异：4.0%，95%CI：-2.9%至 11.5%，p<0.001；和 3.9%，95%CI：-3.1%至 11.5%，p<0.001）。PP 分析也显示非劣效性（96.7%或 96.7%vs.97.4%，差异：-2.9%和-2.9%，p=0.009 和 0.010）。VA-双联、VAC-三联和铋四联疗法的不良事件发生率分别为 39.0%、56.1%和 71.0%。
结论：VA-双联和 VAC-三联疗法在中国南方对 HP 感染非常有效且非劣效于铋四联疗法。鉴于较低的不良反应和较少的抗生素使用，VA-双联疗法是治疗 HP 感染的首选一线治疗。
试验注册：中国临床试验注册中心（注册号：ChiCTR2200056375）。注册于 2022 年 2 月 4 日，网址：https://www.chictr.org.cn/showproj.aspx?proj=14131。
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