ボノプラザン・テトラサイクリン併用療法によるヘリコバクター・ピロリ感染の救済療法：ランダム化比較試験

Treatment of Helicobacter pylori infection after previous eradication failure remains challenging. This study aimed to evaluate the efficacy and safety of vonoprazan-tetracycline (VT) dual regimen as a potential rescue therapy.

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 b.i.d. and tetracycline 500 mg t.i.d.), or bismuth quadruple therapy (BQT; lansoprazole 30mg b.i.d. + colloidal bismuth 150mg t.i.d. + tetracycline 500mg t.i.d. + metronidazole 400mg t.i.d.) for 14 days. The primary outcome was non-inferiority in eradication rates between VT and BQT groups. Secondary outcomes assessed adverse effects in both groups.

Of 350 randomized patients (175 per group), the eradication rates in the VT dual therapy group and the BQT group were 90.6% (154/170, 95%CI 84.9-94.4%) and 89.3% (151/169, 95%CI 83.5-93.4%) in modified-intention-to-treat analysis (difference 1.2%; 95%CI -5.7% to 8.2%; non-inferiority P=0.0003), 91.1% (153/168, 95%CI 85.4-94.7%) and 92.2% (141/153, 95%CI 86.4-95.7%) in per-protocol analysis (difference -1.1%; 95%CI -7.8 to 5.6%; non-inferiority P =0.002), meeting the non-inferiority criterion (P<0.01). The treatment-emergent adverse events were less frequent with dual therapy (10.9% vs 45.7%; P<0.001), and no patient discontinued because of adverse events (0.0% vs 8.6%; P<0.001). Adherence was higher with dual therapy (96.0% vs 87.4%; P=0.006).

Fourteen-day vonoprazan-tetracycline dual therapy is an effective and well-tolerated rescue regimen for Helicobacter pylori infection. This simplified regimen achieved eradication rates non-inferior to BQT while substantially reducing adverse events and improving adherence. (chictr.org.cn, ChiCTR2400080705).