The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 试验地点
- 1
- 主要终点
- The most suitable re-eradication time
研究概览
简要总结
The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.
详细描述
Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer.
At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment in patients with Hp eradication failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.
排除标准
- •Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
研究组 & 干预措施
Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group
Patients in amoxicillin-levofloxacin-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.
干预措施: Amoxicillin , Levofloxacin and Esomeprazole (Drug)
Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group
Patients in amoxicillin-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
干预措施: Amoxicillin , Furazolidone and Esomeprazole (Drug)
Tetracycline-Furazolidone-Esomeprazole-containing quadruple group
Patients in tetracycline-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
干预措施: Tetracycline , Furazolidone and Esomeprazole (Drug)
Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group
Patients in amoxicillin-levofloxacin-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.
干预措施: Amoxicillin,Levofloxacin and Vonoprazan fumarate (Drug)
Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group
Patients in amoxicillin-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
干预措施: Amoxicillin,Furazolidone and Vonoprazan fumarate (Drug)
Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group
Patients in tetracycline-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
干预措施: Tetracycline,Furazolidone and Vonoprazan fumarate (Drug)
结局指标
主要结局
The most suitable re-eradication time
时间窗: 1year
The most suitable re-eradication time will be assessed by paired comparison method .
次要结局
未报告次要终点
研究者
Xiuli Zuo
Professor, Director of gastroenterology department of Qilu hospital
Shandong University