随机,双盲,主动控制的第3期研究,评估Zastaprazan的有效性和安全性与侵蚀性食道炎中的埃索梅普拉相比
Jung-Hwan Oh1, Hyun-Soo Kim2, Dae Young Cheung3
1Division of Gastroenterology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
扎斯塔普拉桑在治疗侵蚀性食道炎方面在8周内表现出与埃索梅普拉的非劣势. 在第4周的早期愈合是显著地更快的 zastaprazan,这表明在酸性反流治疗潜在的好处.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
- 临床医学 临床医学
背景情况:
- 胃食道逆流性疾病 (GERD) 的管理.
- 侵蚀性食道炎 (EE) 治疗景观.
- 对具有竞争力的酸阻断剂 (P-CABs) 的开发.
研究的目的:
- 在EE患者中,与埃索梅普拉相比,评估施塔普拉桑的疗效和安全性.
- 评估愈合率,症状反应和生活质量.
- 研究其对血清胃素水平的影响.
主要方法:
- 第三阶段,多中心,随机,双盲,非劣等性研究.
- 300名受试者确诊患有EE.
- 扎斯塔普拉桑20毫克与埃索梅普拉每天40毫克,持续8周.
主要成果:
- 第8周治愈率:97.92% (扎斯塔普拉桑) 与94.93% (西莫普拉) 相比 (无劣).
- 第4周治愈率显著高于施塔普拉桑 (95.14%与87.68%,P=0.026).
- 在症状反应,生活质量或安全性方面没有显著差异.
结论:
- 扎斯塔普拉桑20毫克对EE在8周内愈合的效果与埃索梅普拉佐尔40毫克无差.
- 扎斯塔普拉桑在第4周的治疗速度更快.
- 这两种治疗都被很好地容忍,安全性概况相似.
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