诺普拉赞作为侵蚀性食道炎的长期维持治疗:VISION,为期5年的随机开放性研究
Naomi Uemura1, Yoshikazu Kinoshita2, Ken Haruma3
1Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai Hospital, Ichikawa, Chiba, Japan.
概括
长期使用诺普拉桑治疗侵蚀性食道炎显示胃蛋白水平增加和胃粘膜变化,但与兰索普拉相比,恶性瘤的风险没有增加.
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.
- 在瘤学瘤学.
背景情况:
- 酸分泌抑制剂可能会导致高胃血和胃粘膜变化.
- 与相竞争的酸阻断剂 (vonoprazan) 是强效的,但缺乏长期安全数据.
- 侵蚀性食道炎 (EE) 需要有效和安全的长期管理.
研究的目的:
- 评估vonoprazan与lansoprazole在治愈了EE的患者中的长期安全性.
- 评估胃粘膜变化和瘤变化的发生率.
主要方法:
- 第四期随机试验:202名患者接受260周的维持治疗.
- 诺普拉赞 (10毫克) 和兰索普拉佐尔 (15毫克) 每天.
- 主要终点:患有特定胃上皮细胞变化的患者比例.
主要成果:
- 在这两组中都没有观察到恶性变化或胃神经内分泌瘤 (NETs).
- 用vonoprazan时,表皮细胞和状细胞增生的发生率更高.
- 类似的ECL细胞和G细胞增生率;高于vonoprazan的中位数血清胃素.
- 在vonoprazan和lansoprazole之间可比的不良事件概况.
结论:
- 在日本患者中评估了vonoprazan的五年安全性概况.
- 诺普拉桑导致胃蛋白水平升高和特异性增多,但并没有增加恶性瘤的风险.
- 结果表明vonoprazan是长期EE管理的安全替代品.
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