基于诺普拉桑的四重疗法与针对 Helicobacter pylori 根除的基于埃索梅普拉的四重疗法不逊色:一个多中心,双盲,随机的,第三期研究
Zhiqiang Song1, Qin Du2, Guoxin Zhang3
1Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China.
Chinese medical journal
|February 18, 2025
概括
与埃索梅普拉相比,诺普拉赞在中国患者的Helicobacter pylori根除中表现出非劣质的疗效. 这两种治疗都被很好地容忍,在本研究中显示了类似的安全性.
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:
- 在中国,抗生素耐药Helicobacter pylori (H. pylori) 的高患病率需要有效的根除策略.
- 建议在该地区进行含有比斯的四重疗法,以根除H. pylori.
- 这项研究解决了对新型H. pylori治疗方案的比较疗效数据的需求.
研究的目的:
- 为了比较基于vonoprazan的四重疗法的疗效和安全性与基于esomeprazole的四重疗法用于H. pylori根除.
- 评估诺普拉桑作为埃索梅普拉的替代品,用于中国患者群体感染H. pylori.
- 为了评估vonoprazan与埃索梅普拉相比在H. pylori根除率方面的非劣势.
主要方法:
- 第三阶段,多中心,随机,双盲,非劣等性研究.
- 1:1随机化为14天的四重疗法:阿莫西西林,克拉里素,酸,加上vonoprazan 20 mg或esomeprazole 20 mg,每天两次.
- 主要结局:治疗后4周使用13C尿素呼吸试验评估的H. pylori根除率;非劣势差额设置为10%.
主要成果:
- 该研究招募了510名患者;506人完成了随访.
- 诺普拉桑实现了86.8% (210/242) 的根除率,埃索梅普拉达到86.7% (208/240) (治疗差异为0.1%;95% CI: -5.95,6.17).
- 每项协议分析显示了相似的比率 (87.4%对86.3%),证实了非劣势 (P=0.0004). 这两种疗法都能很好地耐受,具有可比的安全性.
结论:
- 诺普拉赞对中国患者的H.pylori根除效果与埃索梅普拉无差.
- 含诺普拉桑的治疗方案是H.pylori治疗的安全有效替代方案.
- 这项研究支持使用vonoprazan在高抗生素耐药性区域的H. pylori根除的四重疗法中.
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