Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- eradication rate
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.
详细描述
Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.
H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.
排除标准
- •Age < 18 years old.
- •The time frame was less than 6 months from the previous eradication therapy.
- •The previous eradication therapy included furazolidone.
- •Allergic to the medication.
- •Pregnant or lactating women.
- •Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy.
- •Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.
研究组 & 干预措施
High-dose dual therapy group
esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group
干预措施: esomeprazole plus amoxicillin (Drug)
Furazolidone-based quadruple therapy
furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy
干预措施: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole (Drug)
结局指标
主要结局
eradication rate
时间窗: 42 days
eradication rate of H pylori, presenting with negative results on the 13C-UBT test
次要结局
- frequency of the adverse events(42 days)
- compliance rate of the drugs(42 days)