Vonoprazan-Tetracycline Dual Regimen as Rescue Therapy for Helicobacter pylori Infection: Randomized Controlled Trial.

This study evaluated the efficacy and safety of a vonoprazan-tetracycline (VT) dual regimen as a potential rescue therapy.

本研究评估了伏诺拉赞-四环素(VT)双重方案作为潜在的补救治疗的有效性和安全性。

Methods

In this prospective, open-label, randomized controlled trial, H pylori-positive adults with at least 1 prior eradication failure were allocated 1:1 to VT dual therapy (vonoprazan [20 mg, twice a day] and tetracycline [500 mg, 3 times a day]), or bismuth quadruple therapy (BQT; lansoprazole [30 mg, twice a day], colloidal bismuth [150 mg, 3 times a day], tetracycline [500 mg, 3 times a day], and metronidazole [400 mg, 3 times a day]) for 14 days.

在这项前瞻性、开放标签、随机对照试验中，至少经历过一次根除失败的幽门螺杆菌阳性成人按1:1的比例被分配接受VT双重疗法（vonoprazan[每日两次，每次20毫克]和四环素[每日三次，每次500毫克]）或铋四联疗法（BQT；兰索拉唑[每日两次，每次30毫克]，胶体铋[每日三次，每次150毫克]，四环素[每日三次，每次500毫克]，和甲硝唑[每日三次，每次400毫克]），为期14天。

The primary outcome was noninferiority in eradication rates between VT and BQT groups.

主要结果是VT组和BQT组在根除率上的非劣效性。

Secondary outcomes assessed adverse effects in both groups.

次要结果评估了两组的不良反应。

Results

Of 350 randomized patients (175 per group), the eradication rates in the VT dual-therapy group and the BQT group were, respectively, 90.6% (154 of 170; 95% confidence interval[CI], 84.9%-94.4%) and 89.3% (151 of 169; 95% CI, 83.5%-93.4%) in modified intention-to-treatanalysis (difference, 1.2%; 95% CI,-5.7% to 8.2%; noninferiority P = .0003), 91.1% (153 of 168; 95% CI, 85.4%-94.7%) and 92.2% (141 of 153; 95% CI, 86.4%-95.7%) in per-protocol analysis (difference, -1.1%; 95% CI, -7.8% to 5.6%; noninferiority P = .002), meeting the noninferiority criterion (P < .0125).

在350名随机患者（每组175人）中，VT双重治疗组和BQT组的根除率分别为90.6%（154/170；95%置信区间[CI]，84.9%-94.4%）和89.3%（151/169；95% CI，83.5%-93.4%）在修改后的意向治疗分析中（差异，1.2%；95% CI，-5.7%至8.2%；非劣效性P = .0003），91.1%（153/168；95% CI，85.4%-94.7%）和92.2%（141/153；95% CI，86.4%-95.7%）在按方案分析中（差异，-1.1%；95% CI，-7.8%至5.6%；非劣效性P = .002），满足非劣效性标准（P < .0125）。

Treatment-emergent adverse events were less frequent with dual therapy (10.9% vs 45.7%; P < .001), and no patient discontinued because of adverse events (0.0% vs 8.6%; P < .001).

双药治疗的治疗相关不良事件发生率较低（10.9% 对比 45.7%；P < .001），并且没有患者因不良事件而停药（0.0% 对比 8.6%；P < .001）。

Adherence was higher with dual therapy (96.0% vs 87.4%; P = .006).

双药治疗的依从性更高（96.0% 对比 87.4%；P = .006）。

Conclusions

VT dual therapy for 14 days is an effective and well-tolerated rescue regimen for H pylori infection.

VT双重疗法14天是治疗幽门螺杆菌感染的有效且耐受性良好的补救方案。

This simplified regimen achieved eradication rates noninferior to BQT while substantially reducing adverse events and improving adherence.

这种简化的治疗方案在减少不良事件和提高依从性的同时，达到了与BQT相当的根除率。

Chinese Clinical Trial Registry: ChiCTR2400080705 (chictr.org.cn,).

中国临床试验注册中心：ChiCTR2400080705 (chictr.org.cn,)。