基于诺普拉桑的三重疗法与基于埃索梅普拉的三重疗法用于青少年的H. pylori根除 (VONTAPE):一个随机的,双盲的受控试验
Sameh A Lashen1, Mohammed M Shamseyea2, Rasha H Metwally3
1Department of Internal Medicine (Gastroenterology and Hepatology Division), Faculty of Medicine, Alexandria University, Alexandria, Egypt.
基于诺普拉桑的三重疗法 (VTT) 在青少年中显示出优异的H.pylori根除,而不是基于埃索梅普拉的三重疗法 (ETT). 这种VTT治疗方案在儿科患者中耐受良好.
科学领域:
- 儿科胃肠病学 儿科胃肠病学
- 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:
- 杆菌感染会影响儿童,影响他们的福祉.
- 诺普拉桑在成人H.pylori根除中表现出有效性.
- 诺普拉桑对H.pylori的儿科疗效仍在研究中.
研究的目的:
- 为了比较基于诺普拉桑的三重疗法 (VTT) 与基于埃索梅普拉的三重疗法 (ETT) 在青少年中对H. pylori根除的疗效.
- 在儿科患者中评估VTT与ETT相比的安全性和耐受性.
主要方法:
- 一个多中心,双盲,随机对照试验,涉及242名参与者,年龄在10-18岁,感染H. pylori.
- 参与者接受了14天的ETT (埃索梅普拉/氨基西林/克拉里胺) 或14天的VTT (Vonoprazan/氨基西林/克拉里胺).
- 治疗后8周评估了H. pylori的根除,并记录了不良事件.
主要成果:
- 在意向治疗分析 (p=0.029) 中,VTT臂实现了较高的根除率 (87.6%) 与ETT臂 (76.9%) 相比.
- 每项协议分析还显示,VTT (92.2%) 与ETT (83%) (p=0.036) 的消除率优于VTT (92.2%).
- 两组之间没有观察到总体不良事件的显著差异 (p=0.46).
结论:
- 在儿童和青少年中,基于诺普拉赞的14天的三重治疗比基于埃索梅普拉的三重治疗更有效地消除了H. pylori.
- 在10-18岁的年龄组中,VTT耐受性良好,常见的副作用包括腹和恶心.
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