Simplified Helicobacter pylori therapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy.

IF 23 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gut Pub Date : 2024-08-08 DOI:10.1136/gutjnl-2024-332640

Wen Gao, Jianxiang Liu, Xiaolei Wang, Jingwen Li, Xuezhi Zhang, Hui Ye, Jiang Li, Xinhong Dong, Binbin Liu, Chi Wang, Ying Xu, Guigen Teng, Yuling Tian, Jinpei Dong, Chaoyi Ge, Hong Cheng

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引用次数: 0

Abstract

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.

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针对青霉素过敏患者的幽门螺杆菌简化疗法：沃诺普赞-四环素双重疗法随机对照试验。

背景和目的：本研究旨在评估青霉素过敏患者在幽门螺杆菌感染一线治疗中使用冯诺普拉赞和四环素（VT）双重疗法的有效性和安全性：在这项随机对照试验中，对幽门螺杆菌感染和青霉素过敏的成人患者接受了治疗。方法：在这项随机对照试验中，幽门螺杆菌感染和青霉素过敏的成人患者按 1:1 随机分配，接受开放标签 VT 双联疗法（沃诺普赞 20 毫克，每天两次；四环素 500 毫克，每天三次）或铋剂四联疗法（BQT；兰索拉唑 30 毫克，每天两次；胶体铋 150 毫克，每天三次；四环素 500 毫克，每天三次；甲硝唑 400 毫克，每天三次）治疗 14 天。主要结果是 VT 双联组的根除率与 BQT 组相比无劣效。次要结果包括评估不良反应：300名患者接受了随机治疗。VT组和BQT组的根除率分别为在意向治疗分析中，根除率分别为92.0%（138/150，95% CI 86.1%至95.6%）和89.3%（134/150，95% CI 83.0%至93.6%）（差异为2.7%；95% CI -4.6%至10.0%；非劣效P=0.000）；在修正治疗分析中，根除率分别为94.5%（138/146，95% CI 89.1%至97.4%）和93.1%（134/144，95% CI 87.3%至96.4%）。在修正的意向治疗分析中为94.5%（138/146，95% CI为89.1%至97.4%）和93.1%（134/144，95% CI为87.3%至96.4%）（差异为1.5%；95% CI为-4.9%至8.0%；非劣效性P=0.001）；在按协议分析中为95.1%（135/142，95% CI为89.7%至97.8%）和97.7%（128/131，95% CI为92.9%至99.4%）（差异为2.6%；95% CI为-2.9%至8.3%；非劣效性P=0.000）。VT组的治疗突发不良事件（TEAEs）显著较低（14.0% vs 48.0%，P=0.000），因TEAEs而中断治疗的人数较少（2.0% vs 8.7%，P=0.010）：VT双重疗法作为青霉素过敏人群幽门螺杆菌感染的一线治疗方案，具有良好的疗效和安全性，与传统的BQT相比，疗效相当，TEAEs发生率较低：试验注册号：ChiCTR2300074693。

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来源期刊

Gut 医学-胃肠肝病学

CiteScore

45.70

自引率

2.40%

发文量

284

审稿时长

1.5 months

期刊介绍： Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.