临床试验:简化肠道准备小肠囊内镜在克罗恩氏病
Raphaëlle Rouveyre1, Sandrine Coudol2, Michael Collins1
1Institut des Maladies de L'appareil Digestif (IMAD), Hépato-Gastro-Entérologie et Assistance Nutritionnelle, Inserm CIC 1413, Nantes Université, CHU Nantes, Nantes, France.
对于小肠囊内镜 (SBCE) 的简化肠道制剂在克罗恩病 (CD) 患者中与基于聚乙烯糖醇 (PEG) 的方法一样有效. 这种方法可以提高患者的可接受性,而不会影响诊断产量.
科学领域:
- 胃肠病学 胃肠病学
- 内镜检查是指内镜检查.
- 消化系统疾病 消化系统疾病
背景情况:
- 小肠囊内镜 (SBCE) 对于诊断克罗恩病 (CD) 是至关重要的.
- 在CD患者中优化SBCE的肠道准备仍然是一个重大的临床挑战.
- 目前的准备方案各不相同,影响患者体验和程序的有效性.
研究的目的:
- 为了比较简化肠道制备方案与基于聚乙烯糖醇 (PEG) 的标准方案对SBCE在已确定的CD患者的疗效.
- 评估肠道清洁度,患者接受度,诊断产量,囊完成和小肠传输时间 (SBTT) 的差异.
主要方法:
- 一个随机的,受控的,单盲的,多中心的优越性试验,涉及142个SBCE程序.
- 患者被分配给一种简化的制剂 (含水的清洁液体饮食) 或一种基于PEG的制剂 (含PEG的无残留物饮食).
- 用KODA分数和定性评估来评估肠道清洁性;收集了患者报告的结果和程序数据.
主要成果:
- 简化和基于PEG的制剂组之间没有观察到肠道清洁度的显著差异.
- 对于简化制剂来说,患者接受度显著更高.
- 诊断产量,囊完成率和SB传输时间在两组之间是可比的.
结论:
- 简化肠道制剂 (清洁液体饮食和水) 是一种可行且有效的替代品,可以替代CD患者的SBCE的PEG制剂.
- 这种简化方法可以实现可比的肠道清洁和诊断结果.
- 简化的制剂提供了更好的患者接受度,增强了CD患者的整体SBCE体验.
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