随机,双盲,主动控制,并行,第三期临床试验,用于评估Zastaprazan在患有胃的患者中的有效性和安全性
Kyung Sik Park1, Hyun-Soo Kim2, Jung-Hwan Oh3
1Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea.
在一项为期8周的研究中,Zastaprazan (JP-1366) 是一种新型的酸阻断剂,在治疗胃方面被证明与兰索普拉无差. 这两种治疗方法在患者中显示了可比的安全性和疗效.
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:
- 扎斯塔普拉桑 (JP-1366) 是一种新型的竞争性酸阻断剂 (PCAB),具有迅速发作和持续作用.
- 胃是一种严重的胃肠道疾病,需要有效和安全的治疗方案.
研究的目的:
- 在被诊断患有胃的患者中,与兰索普拉相比,评估施塔普拉桑的疗效和安全性.
- 为了确定 zastaprazan 是否在实现胃愈合方面与兰索普拉不逊色.
主要方法:
- 这是一项3期,多中心,随机,双盲,主动控制的试验,涉及329名确诊胃的受试者.
- 参与者每天接受一次20毫克的斯塔普拉桑或30毫克的兰索普拉,长达8周.
- 主要终点:通过内镜检查8周后胃累积愈合率;次要终点:愈合率,症状恢复,生活质量和安全.
主要成果:
- 在8周后,斯塔普拉桑的累积愈合率为100.00%,兰索普拉的累积愈合率为97.06%. 第4周的治愈率分别为93.84%和91.91%.
- 扎斯塔普拉桑在胃治愈方面表现出与兰索普拉相比的非劣势.
- 在两组治疗中,不良事件发生率是可比的;在治疗期间,胃素水平出现过渡性增加.
结论:
- 用斯塔普拉桑20毫克治疗八周的治疗效果与兰索普拉佐尔30毫克治疗胃的效果不逊色.
- 扎斯塔普拉桑和兰索普拉在患有胃的患者中表现出类似的安全性.
- 该研究 (NCT05448001) 支持 zastaprazan 作为胃的有效治疗选择.
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