Comparative Analysis of High-Dose Dual Therapies in First-Line Helicobacter Pylori Eradication: A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
Background:
High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.
Methods:
A multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.
详细描述
This study is a multicenter, retrospective, observational study utilizing medical records of outpatients who received standard high-dose dual therapy (HDDT) for Helicobacter pylori eradication between January 2022 and January 2025. The aim was to compare the efficacy and adverse event rates of different HDDT regimens.
Collected data included:
Baseline demographics (age, sex, etc.)
Medical/lifestyle history
Treatment regimens
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
- •(1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
排除标准
- •(1) patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments; (2) patients who received treatment regimens that did not conform to the standardized HDDT protocol specified in this study.
结局指标
主要结局
Eradication rate
时间窗: 4-6 weeks
Comparison of Eradication Rates among Four Different High-Dose Dual Therapies for Helicobacter pylori
Comparison of Eradication Rates Among Four Different High-Dose Dual Therapies for Helicobacter pylori
时间窗: 4-6 weeks
次要结局
- Adverse Events and Compliance(4-6 weeks)
研究者
Liyueyue
Associate Professor
Qilu Hospital of Shandong University