0.8L与2L聚乙烯糖醇-甲酸溶液在结肠镜准备中的比较有效性和安全性:一个前性,多中心,随机,受控试验
Bomee Lee1, Bora Keum1, Sung Noh Hong2
1Department of Internal Medicine, Division of Gastroenterology and Hepatology, Korea University College of Medicine, Seoul, South Korea.
Journal of gastroenterology and hepatology
|July 24, 2025
概括
一种新的低容量聚乙烯甘醇 (PEG) - 亚酸溶液证明了有效和安全的结肠清洁,与更高容量的选择相比. 同一天的治疗方案改善了患者的满意度,并显示出更好的疗效的趋势.
科学领域:
- 胃肠病学 胃肠病学
- 结肠直肠癌查 结肠直肠癌查
- 医疗器械开发 医疗器械开发
背景情况:
- 用于结肠镜检查准备的高容量聚乙烯甘醇 (PEG) 溶液面临合规性挑战.
- 低量替代品可能会增加不良事件的风险.
- 为了解决这些问题,开发了一种新型的0.8-L PEG-ascorbic 酸溶液与simethicone.
研究的目的:
- 为了比较新的0.8L PEG-亚酸溶液与标准的2L PEG-亚酸溶液的疗效,安全性和耐受性.
- 为了评估0.8L溶液的不同剂量方案.
- 评估患者的满意度和肠道准备质量.
主要方法:
- 一项前性,调查者盲目的研究将137名门诊患者随机分为三个组.
- 组A:0.8L的PEG-甲酸 (分剂量). 组A:0.8L的PEG-甲酸 (分剂量).
- 组B:0.8L的PEG-甲酸 (同一天).
- 组C:2-L PEG-甲酸 (分剂量).
- 使用Harefield清洁量表 (HCS) 评估了清洁功效.
- 其次要结果包括泡评分,多/腺瘤检测,满意度,耐受性和安全性.
主要成果:
- 所有小组都取得了100%的成功准备 (HCS等级A/B).
- 0.8L的PEG-甲酸溶液显示与2L溶液相比具有非劣质性.
- B组 (同一天0.8-L) 显示出更好的上升结肠清洁 (HCS 3.2与3.0,p=0.01) 和更高的患者满意度的趋势.
- 与C组相比,A组和B组的泡分数明显更好 (p<0.0001).
- 在所有组中,多和腺瘤检测率相似.
- 耐受性和安全性概况是可比的.
结论:
- 0.8L PEG-亚斯科布酸溶液是一种有效,安全和耐受良好的结肠镜制备替代品.
- 0.8L溶液的同一天治疗方案在患者满意度和结肠清洁方面提供了潜在的优势.
- 这种新的配方代表了患者对肠道准备的遵守和经验的改善.
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