在Helicobacter pylori感染的未经治疗的患者中,基于Cefuroxime的双重治疗与四重治疗的比较:一个前性的,多中心的,随机对照试验
Ji-Yan Li1, Ji-Chun Song2, Xia Tian3
1Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
基于塞福洛キシ姆的四重疗法 (CQT) 显示出比塞福洛キシ姆双疗法 (CDT) 更高的Helicobacter pylori根除率,为青素过敏患者提供了更好的选择. 当CQT不适合时,CDT仍然是一个可行的替代方案.
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:
- 高剂量的阿莫西西林双疗对H.pylori根除有效,但不适合青素过敏患者.
- 素是一种潜在的替代品,但其在H. pylori的双重治疗中的有效性尚未报告.
- 这项研究比较了基于 cefuroxime 的双疗法 (CDT) 与针对 H. pylori 感染的基于 cefuroxime 的双疗法 (CQT).
研究的目的:
- 为了比较CDT和CQT在治疗H. pylori感染中的疗效,安全性和合规性.
- 评价 cefuroxime 作为 H. pylori 根除方案的一个组成部分.
- 为需要根除H. pylori的青素过敏个体提供治疗选择.
主要方法:
- 一个前性的,多中心的,开放的,随机对照试验招募了700名未接受过治疗的H. pylori患者.
- 患者被随机分配,接受14天的CDT (Cefuroxime,Vonoprazan) 或14天的CQT (Cefuroxime,Levofloxacin,Vonoprazan,Bismuth).
- 通过治疗意图,修改治疗意图和每条协议分析来评估有效性. 还评估了安全性和合规性.
主要成果:
- 与CDT (76.0% ITT, 78.9% mITT, 80.2% PP) 相比,CQT实现了更高的根除率 (86.3% ITT, 89.1% mITT, 91.2% PP) (所有人的P<0.001).
- 在CDT组 (14.4%) 的不良事件明显低于在CQT组 (29.8%) (P < 0.001).
- 两组之间证实了非劣势性 (P > 0.025),并且两组的合规性都很好 (96.0%对92.8%,P=0.073).
结论:
- 基于塞福洛キシ姆的四重疗法 (CQT) 在消除H. pylori方面比基于塞福洛キシ姆的双重疗法 (CDT) 更有效.
- 建议CQT用于需要根除H. pylori的青素过敏患者.
- 如果CQT是禁忌或不能容忍,CDT可以作为一个可行的替代方案.
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