曼尼托尔用于肠道制备:SATISFACTION随机临床试验的有效性和安全性结果
Maurizio Vecchi1, Gian Eugenio Tontini1, Giancarla Fiori2
1Department of Pathophysiology and Organ Transplantation, University of Milan, Milan, Italy; IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Milan, Italy.
概括
单剂量口服曼尼托尔提供与分剂量PEG-ASC相比的肠道清洁,显著改善了患者的满意度. 这种低容量制剂是高质量的结肠镜检查的可行替代品.
科学领域:
- 胃肠病学 胃肠病学
- 内镜检查是指内镜检查.
- 临床试验 临床试验
背景情况:
- 有效的肠道准备对于高质量的结肠镜检查至关重要.
- 口服曼尼托尔提供低容量,单剂量选择,具有愉快的味道和快速作用.
研究的目的:
- 为了比较单剂量口服曼尼托尔的疗效和患者满意度,与分剂量聚乙烯糖醇-甲酸 (PEG-ASC) 相比.
主要方法:
- 这是一项随机对照试验,涉及703名患者.
- 主要终点:充分的肠道清洁.
- 二级终点:有效性,安全性和患者满意度.
主要成果:
- 曼尼托尔在肠道清洁方面与PEG-ASC无差 (91.1%对95.5%).
- 没有观察到二次疗效或安全性终点的显著差异.
- 曼尼托尔显示出显著更高的患者接受度 (易于使用,口味,愿意重复使用).
结论:
- 单剂量口服曼尼托尔是一种耐受性良好的,有效的肠道制备替代品.
- 它的优越的患者可接受性解决了结肠镜准备的未满足的临床需求.
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