Randomized and Controlled Clinical Study of High-dose Dual Therapy with Different Administration Frequencies in the Treatment of Helicobacter Pylori
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.
详细描述
According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.
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
排除标准
- •Pregnant and lactating women;
- •History of gastrointestinal malignancies;
- •History of previous subtotal gastrectomy;
- •Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
- •History of hematological diseases
- •People who are allergic to drugs;
- •The guardian or patient refused to join the group;
- •Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
- •No legal capacity or poor self-knowledge
- •administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
研究组 & 干预措施
dual therapy B
Vonoprazan 20mg bid ac and amoxicillin 1g tid pc
干预措施: Amoxicillin (Drug)
dual therapy A
Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc
干预措施: vonoprazan (Drug)
dual therapy A
Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc
干预措施: Amoxicillin (Drug)
dual therapy B
Vonoprazan 20mg bid ac and amoxicillin 1g tid pc
干预措施: vonoprazan (Drug)
dual therapy C
Vonoprazan 20mg bid ac and amoxicillin 1g tid ac
干预措施: vonoprazan (Drug)
dual therapy C
Vonoprazan 20mg bid ac and amoxicillin 1g tid ac
干预措施: Amoxicillin (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-rea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
次要结局
- Rate of adverse events(Within 7 days after completion of therapy)
- 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
RenJi Hospital