The Trend of Eradication Rates of First-line Triple Therapy for Helicobacter Pylori and Clinical Factors That Affect the Eradication in Korean: Single Center Experience for Recent Ten Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Eradication Rates of First-line Triple Therapy for Helicobacter pylori
研究概览
简要总结
The purpose of this study is to investigate the trend of eradication rates of first-line triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect the eradication in Korean.
详细描述
A PPI triple regimen combining a proton pump inhibitor(PPI) with two antibiotics (amoxicillin and clarithromycin) is currently considered the gold standard therapy for eradication of H. pylori. However, recently the eradication rate with first-line treatment has a tendency to decrease because of increasing antibiotics resistance. In addition, PPI is mainly metabolized by cytochrome p450 2C19 (CYP2C19) in the liver and several reports have suggested that differences in th CYP2C19 genotype are associated with H. pylori eradication failure. Thus, the first aim of this study is to investigate the trend of eradication rates of first-line triple therapy in recent ten years. And the second aim is to analyze the antibiotics resistance rate for H. pylori by using culture minimal inhibitory concentrations(MICs) result and to analyze the association between CYP2C19 genotype and eradication rate of H.pylori. And also investigate the other clinical factors (age, gender, underlying disease, cigarette smoking and alcohol use) that affect the eradication rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 92 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who proven H. pylori infection by invasive or non-invasive H. pylori test
- •Patients treated with First-line triple therapy (PPI + Amoxicillin + Clarithromycin)
排除标准
- •Previous eradication therapy for H. pylori
- •Follow-up loss patients after eradication therapy
- •Other treatment regimen
- •Poor medication compliance (<80%)
研究组 & 干预措施
PPI triple therapy
7-day PPI triple therapy regimen: PPI (esomeprazole 40 mg or omeprazole 20 mg or lansoprazole 30 mg or pantoprazole 40 mg or rabeprazole 20 mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.
干预措施: PPI triple therapy (Drug)
结局指标
主要结局
Eradication Rates of First-line Triple Therapy for Helicobacter pylori
时间窗: Four weeks after completing eradication therapy
Non invasive H. pylori test (13C-urea breath test(UBT)) or invasive H. pylori test (Giemsa histology, Rapid Urease test) were performed after four weeks after completing eradication therapy.
次要结局
- Clinical Factors that Affect the Eradication(Four weeks after completing eradication therapy)
研究者
Nayoung Kim
Professor, M.D.
Seoul National University Bundang Hospital