优化Vonoprazan-Amoxicillin双重治疗Helicobacter pylori的持续时间和剂量频率:一个多中心随机试验
Lulong Tao1, Haisheng Qian1, Leyao Zhang2
1Department of Gastroenterology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiansgsu, China.
一个为期10天的vonoprazan-amoxicillin (VA) 疗法与每天三次1000毫克的阿莫西林有效地消除了Helicobacter pylori. 由于效率较低,不建议使用较短的7天疗程.
科学领域:
- 胃肠病学 胃肠病学
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 在初始治疗中,通过10天的诺普拉桑-阿莫西西林 (VA) 疗法实现了Helicobacter pylori (H. pylori) 根除的高率.
- 关于简化,更短时间的VA疗法对H.pylori根除的疗效的不确定性.
- 需要确定最佳的第一线H. pylori治疗策略.
研究的目的:
- 评估简化7天和10天VA疗法对一线H.pylori根除的疗效.
- 为了在7天和10天的VA治疗持续时间内比较不同的阿莫西西林剂量频率.
- 确定H. pylori根除的最佳一线策略.
主要方法:
- 多中心,随机化,开放性,非劣势性试验,涉及未经治疗的H. pylori阳性患者.
- 四个治疗组:VA-T7 (阿莫西西林1000毫克三次一天为7天),VA-Q7 (阿莫西西林750毫克三次一天为7天),VA-T10 (阿莫西西林1000毫克三次一天为10天),和VA-Q10 (阿莫西西林750毫克三次一天为10天).
- 所有患者每天两次服用vonoprazan 20 mg;主要结局是根除率;次要结局包括不良事件和坚持.
主要成果:
- 10天的VA-T10疗法实现了91.2% (ITT),92.7% (mITT) 和93.4% (PP) 的根除率,表明与VA-Q10无劣.
- 两种7天疗法 (VA-T7和VA-Q7) 都未能达到非劣势差额,根除率低于90%.
- 根据阿莫西西林剂量频率,没有观察到根除率的显著差异;所有组的不良事件和坚持是可比的.
结论:
- 10天的诺普拉桑-阿莫西西林疗法 (VA-T10) 是一项有效且耐受良好的选择,用于一线的H. pylori根除.
- 在初始H. pylori治疗中不建议使用七天的VA疗法,因为根除率低于最佳 (<90%).
- VA-T10疗法代表了H. pylori根除的合适的第一线策略.
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