Simplified Helicobacter pylori therapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy.
| Autor: | Gao W; GI Department, Peking University First Hospital, Beijing, Beijing, China., Liu J; GI Department, Peking University First Hospital, Beijing, Beijing, China., Wang X; GI Department, Peking University First Hospital, Beijing, Beijing, China., Li J; Tsinghua University School of Medicine, Beijing, Beijing, China., Zhang X; TCM and Integrative Medicine Department, Peking University First Hospital, Beijing, Beijing, China., Ye H; TCM and Integrative Medicine Department, Peking University First Hospital, Beijing, Beijing, China., Li J; GI Department, Peking University First Hospital, Beijing, Beijing, China., Dong X; GI Department, Peking University First Hospital, Beijing, Beijing, China., Liu B; GI Department, Peking University First Hospital, Beijing, Beijing, China., Wang C; GI Department, Peking University First Hospital, Beijing, Beijing, China., Xu Y; GI Department, Peking University First Hospital, Beijing, Beijing, China., Teng G; GI Department, Peking University First Hospital, Beijing, Beijing, China., Tian Y; GI Department, Peking University First Hospital, Beijing, Beijing, China., Dong J; GI Department, Peking University First Hospital, Beijing, Beijing, China., Ge C; GI Department, Peking University First Hospital, Beijing, Beijing, China., Cheng H; GI Department, Peking University First Hospital, Beijing, Beijing, China chenghong1969@163.com. |
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| Jazyk: | angličtina |
| Zdroj: | Gut [Gut] 2024 Aug 08; Vol. 73 (9), pp. 1414-1420. Date of Electronic Publication: 2024 Aug 08. |
| DOI: | 10.1136/gutjnl-2024-332640 |
| Abstrakt: | Background and Aims: This study aimed to evaluate the efficacy and safety of vonoprazan and tetracycline (VT) dual therapy as first-line treatment for Helicobacter pylori infection in patients with penicillin allergy. Methods: In this randomised controlled trial, treatment-naïve adults with H. pylori infection and penicillin allergy were randomised 1:1 to receive either open-label VT dual therapy (vonoprazan 20 mg two times per day+tetracycline 500 mg three times a day) or bismuth quadruple therapy (BQT; lansoprazole 30 mg two times per day+colloidal bismuth 150 mg three times a day+tetracycline 500 mg three times a day+metronidazole 400 mg three times a day) for 14 days. The primary outcome was non-inferiority in eradication rates in the VT dual group compared with the BQT group. Secondary outcomes included assessing adverse effects. Results: 300 patients were randomised. The eradication rates in the VT group and the BQT group were: 92.0% (138/150, 95% CI 86.1% to 95.6%) and 89.3% (134/150, 95% CI 83.0% to 93.6%) in intention-to-treat analysis (difference 2.7%; 95% CI -4.6% to 10.0%; non-inferiority p=0.000); 94.5% (138/146, 95% CI 89.1% to 97.4%) and 93.1% (134/144, 95% CI 87.3% to 96.4%) in modified intention-to-treat analysis (difference 1.5%; 95% CI -4.9% to 8.0%; non-inferiority p=0.001); 95.1% (135/142, 95% CI 89.7% to 97.8%) and 97.7% (128/131, 95% CI 92.9% to 99.4%) in per-protocol analysis (difference 2.6%; 95% CI -2.9% to 8.3%; non-inferiority p=0.000). The treatment-emergent adverse events (TEAEs) were significantly lower in the VT group (14.0% vs 48.0%, p=0.000), with fewer treatment discontinuations due to TEAEs (2.0% vs 8.7%, p=0.010). Conclusions: VT dual therapy demonstrated efficacy and safety as a first-line treatment for H. pylori infection in the penicillin-allergic population, with comparable efficacy and a lower incidence of TEAEs compared with traditional BQT. Trial Registration Number: ChiCTR2300074693. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Databáze: | MEDLINE |
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