Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Real-world Evidence Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 823
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Confirmed H. pylori infection and with previous treatment failure
排除标准
- •subjects naive to H. pylori treatment,
- •history of gastrectomy
- •pregnant or lactating women
- •severe systemic diseases or malignancy
- •administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 12 weeks
研究组 & 干预措施
BQT
干预措施: BQT (Drug)
PBM4M4
干预措施: PBM4M4 (Drug)
PBM3M3
干预措施: PBM3M3 (Drug)
PBM2M4
干预措施: PBM2M4 (Drug)
PBM2M3
干预措施: PBM2M3 (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 defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
次要结局
- Rate of adverse effects(Within six weeks after completion of therapy)
- Compliance rate(Within six weeks 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
