Rifabutin-containing Triple Therapy for Rescue Treatment of Helicobacter Pylori: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory 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
- •ability and willingness to participate in the study and to sign and give informed consent
- •Confirmed H. pylori infection and with previous treatment experience
排除标准
- •Less than 18 years old
- •With previous gastric surgery
- •Previous history of tuberculosis
- •Major systemic diseases
- •Pregnancy or lactation
- •Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
研究组 & 干预措施
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Esomeprazole (Drug)
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Bismuth Potassium Citrate (Drug)
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Tetracycline,Metronidazole (Drug)
rifabutin triple therapy
Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid
干预措施: Esomeprazole (Drug)
rifabutin triple therapy
Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid
干预措施: amoxicillin rifabutin (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was
次要结局
- Compliance rate(Within 7 days after completion of therapy)
研究者
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
Shanghai Jiao Tong University School of Medicine