Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 13C-urea breath test
研究概览
简要总结
The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study.
排除标准
- •patients with peptic ulcer,
- •previous H. pylori eradication treatment,
- •previous gastric surgery,
- •pregnancy,
- •lactation,
- •major systemic diseases,
- •receipt of anti-secretory therapy,
- •antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.
研究组 & 干预措施
Group RBLF
receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).
干预措施: RBLF (Drug)
Group RA
receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).
干预措施: RA (Drug)
结局指标
主要结局
13C-urea breath test
时间窗: 4 weeks after treatment
When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).
次要结局
- scale analysis of drug safety(4 weeks after treatment)
研究者
Xiaobo Li
Xiaobo Li
Shanghai Jiao Tong University School of Medicine