Comparison of Vonoprazan Fumarate-based Triple Therapy Versus Proton Pump Inhibitor and Bismuth Based Quadruple Therapy in the Eradication of Helicobacter Pylori: a Single-center Prospective Open-label Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Eradication rate of Hp at one time
研究概览
简要总结
To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. The four treatment regimens included (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline.
详细描述
A single-center, prospective, open-label, parallel control design was conducted to enroll 100 patients with confirmed Helicobacter pylori infection. Patients were randomly divided into four groups, respectively accept four treatment regimens including (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline. The effectiveness, safety and compliance of the four regimens were compared, and the cost-benefit analysis of the different regimens was conducted. The purpose of this study was to explore the most appropriate treatment plan for radical treatment of Helicobacter pylori .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, ≤80 years
- •Urea breath test (UBT) was positive for Hp infection;
- •WIthout any anti-Hp treatment before
- •Endoscopy was performed within 1 month
- •Understanding the purpose and procedure of the study, voluntarily participating in the study and signing a written informed consent.
排除标准
- •Allergic to drugs used in this clinical study;
- •Using PPI, histamine H2 receptor antagonist, antibiotics, bismuth, probiotics or drugs with antibacterial effects within 4 weeks before treatment.
- •Using adrenal corticosteroids, non-steroidal anti-inflammatory drugs and anticoagulants
- •The disease or clinical condition that may interfere with the treatment evaluation of the study, such as liver disease, cardiovascular disease, lung disease, kidney disease, metabolic disease, psychiatric disease, or malignant tumor
- •Pregnant or lactating women
- •Participated in other clinical studies within 3 months prior to the registration of this clinical study
- •Suspected history of antibiotic abuse
- •Patients with craniocerebral injury, mental illness or epilepsy who cannot communicate with others or other diseases that may affect follow-up
研究组 & 干预措施
Group1: Vonoprazan Fumarate + amoxicillin + doxycycline
干预措施: Group1 Vonoprazan Fumarate + amoxicillin + doxycycline (Drug)
Group2: Vonoprazan Fumarate + furazolidone + doxycycline
干预措施: Group2 Vonoprazan Fumarate + furazolidone + doxycycline (Drug)
Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
干预措施: Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline (Drug)
Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
干预措施: Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline (Drug)
结局指标
主要结局
Eradication rate of Hp at one time
时间窗: 43 or 57 days after the initiation of eradication therapy
The UBT test was performed to determine whether Hp was eradicated. No antibiotics, bismuth, or PPI were taken during this period. ITT analysis and PP analysis were used.
次要结局
- Adverse events(43 or 57 days after the initiation of eradication therapy)
- Cost-benefit analysis(43 or 57 days after the initiation of eradication therapy)
研究者
wang xiaoyan
Director, Head of Gastroenterology, Principal Investigator, Clinical Professor
The Third Xiangya Hospital of Central South University