在接受结肠镜检查的成年人中,与口服硫酸盐溶液相比,一种新的,风味优化的聚乙烯甘醇和硫酸盐肠道制剂与口服硫酸盐溶液进行了比较
Raj Bhandari1, Michael Goldstein2, Daniel S Mishkin3
1Delta Research Partners, Monroe, LA.
Journal of clinical gastroenterology
|July 25, 2023
概括
一种含有聚乙烯糖醇和硫酸盐的新型风味肠道制剂 (FPSS) 证明与口服硫酸盐溶液 (OSS) 在结肠镜清洁中具有非劣质性. 由于其类似运动饮料的味道,FPSS被患者容忍得很好,并且被患者喜欢.
科学领域:
- 胃肠病学 胃肠病学
- 结肠直肠癌查 结肠直肠癌查
- 药理学 药理学是指药理学的学科.
背景情况:
- 结肠镜检查需要有效的肠道准备,以获得最佳的可视化.
- 现有的肠道制剂,如口服硫酸盐溶液 (OSS),可能存在耐受性问题.
- 为改善患者体验,开发了一种新型的调味聚乙烯甘和硫酸盐溶液 (FPSS).
研究的目的:
- 为了评估FPSS的疗效和安全性,与OSS相比,用于结肠镜准备.
- 评估患者对新型口味肠道制剂的接受度和耐受性.
主要方法:
- 这是一项多中心的非劣势性研究,涉及500名成年受试者.
- 根据批准的标签,受试者接受了FPSS (2L分剂量) 或OSS.
- 结肠镜检查的质量由盲目检查人员评估全球和细分;安全性通过不良事件和实验室测试.
主要成果:
- FPSS实现了94%的清洗成功率,证明了对OSS (94%) 的非劣势.
- 这两种药物都显示出>90%的细分成功率,包括右结肠.
- 患者更喜欢FPSS (87%对比OSS的74%) 并且据报道味道像运动饮料;没有观察到不良事件或实验室参数的显著差异.
结论:
- 风味聚乙烯甘和硫酸盐溶液 (FPSS) 是肠道制备的安全有效替代品.
- FPSS实现了高结肠清洗成功率,与口服硫酸盐溶液 (OSS) 相美.
- 改善的FPSS风味特征显著提高了患者的接受度和耐受性.
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