Efficacy and Safety of 7-day Triple Therapy Containing Amoxicillin and Tetracycline Versus 14-day Dual Therapy for Helicobacter Pylori Eradication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- eradication rate
研究概览
简要总结
With the increasing prevalence of antibiotic resistance, the clinical efficacy of conventional 7-day triple therapy for Helicobacter pylori eradication has been substantially diminished. However, the efficacy and safety of a 7-day triple regimen based on amoxicillin and tetracycline warrant further investigation. This retrospective study was designed to compare the efficacy and safety of a 7-day triple therapy based on amoxicillin and tetracycline combination versus the standard 14-day high-dose dual therapy for H. pylori infection. Data on therapies for H. pylori eradication were extracted between January 2023 and October 2025 at Qilu Hospital of Shandong University. Two regimens were compared based on 1:3 propensity score matching: 7-day triple therapy (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily) and 14-day high-dose dual therapy (vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily). Eradication rates and incidence of adverse events were assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18-70 years;
- •patients with H. pylori infection confirmed by 13C/14C-urea breath test or rapid urease test;
- •patients with no history of H. pylori eradication therapy
排除标准
- •patients with severe underlying diseases, such as hepatic insufficiency, renal insufficiency, immunosuppression, malignant tumors, and coronary heart disease;
- •patients with active gastrointestinal bleeding;
- •patients with a history of upper gastrointestinal surgery;
- •patients allergic to treatment drugs;
- •patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks;
- •patients who were pregnant or lactating or unwilling to take contraceptive measures during the trial;
- •patients with other behaviors that may increase the risk of disease, such as alcohol and drug abuse;
- •incomplete data.
研究组 & 干预措施
dual therapy
干预措施: 14-day dual therapy (Drug)
triple therapy
干预措施: 7-day triple therapy (Drug)
结局指标
主要结局
eradication rate
时间窗: six weeks after treatment
次要结局
- incidence of adverse events(immediately after treatment)
研究者
Yueyue Li
Associate Professor
Qilu Hospital of Shandong University