双盲多中心随机临床试验比较葡萄糖和安慰剂在解决食物食道冲击的解决方案
Marina de Benito Sanz1, Javier Tejedor-Tejada2, Carolina Mangas-Sanjuan3
1Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain.
葡萄糖在解决食道外体冲击 (EFBI) 或减少手术时间方面没有比安慰剂更有效. 在这两组中,轻微的喉疼痛是最常见的不良事件.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 食道外体冲击 (EFBI) 是一个常见的临床情景.
- 目前的管理通常涉及内镜去除.
- 调查像葡萄糖素这样的药理学辅助剂可能会改善结果.
研究的目的:
- 为了比较静脉注射葡萄糖与安慰剂在解决EFBI方面的疗效.
- 评估葡萄糖对内镜手术时间的影响.
- 为了评估与EFBI的葡萄糖管理相关的不良事件.
主要方法:
- 多中心,随机,双盲试验.
- 包括连续诊断有食物EFBI的患者.
- 随机给予1毫克静脉注射葡萄糖或安慰剂,然后进行上部内镜检查.
主要成果:
- 葡萄糖 (23.6%) 和安慰剂 (20.6%) 组之间的异物识别率没有显著差异 (P = 0.67).
- 平均手术时间相似:4分钟 (葡萄糖素) 与3.5分钟 (安慰剂) (P = 0.59).
- 在这两支治疗手臂中,轻微的喉疼痛是最常见的不良事件.
结论:
- 静脉注射的葡萄糖对消除EFBI并不比安慰剂更有效.
- 葡萄糖并没有显著缩短外体去除所需的时间.
- 进一步的研究可能会探索EFBI的替代药理干预措施.
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