巴雷特食道中的埃索梅普拉和阿司匹林 (AspECT):随机因子试验
Janusz A Z Jankowski1, John de Caestecker2, Sharon B Love3
1Gastroenterology Unit, Morecambe Bay University Hospitals NHS Trust, Lancaster, UK; National Institute for Health and Care Excellence, London, UK.
Lancet (London, England)
|July 31, 2018
概括
高剂量的质子抑制剂 (PPI) 和阿司匹林显著改善了巴雷特食道患者的结果. 高剂量的PPI与阿司匹林的结合显示出最强的保护作用,报告的不良反应最小.
科学领域:
- 胃肠病学
- 癌症学
- 临床药理学
背景情况:
- 消化管腺癌是全球癌症死亡的主要原因.
- 巴雷特的食道是这种癌症的主要危险因素.
- 评估化疗预防策略对于管理巴雷特食道至关重要.
研究的目的:
- 评估高剂量质子抑制剂 (PPI) 和阿司匹林在改善巴雷特食道患者的治疗结果方面的有效性.
- 在化疗预防试验中,将高剂量与低剂量PPI进行比较.
主要方法:
- 一个2x2因子随机对照试验,涉及85个中心的2557名患者.
- 患者接受高剂量 (每天两次40毫克) 或低剂量 (每天一次20毫克) PPI,与或没有阿司匹林 (每天300-325毫克) 至少8年.
- 主要终点:使用加速失效时间建模分析的全因死亡率,食道腺癌或高度发育不良.
主要成果:
- 高剂量的PPI优于低剂量的PPI (p=0. 038).
- 当非类固醇抗炎药物使用被审查时,阿司匹林显示出显著的益处 (p=0. 043).
- 高剂量的PPI与阿司匹林的结合显示出最强的保护作用 (p=0. 0068),报道的不良事件很少.
结论:
- 高剂量的PPI和阿司匹林化疗,特别是在组合中,显著改善了巴雷特食道患者的结果.
- 这种治疗方案被认为是安全的,只有1%的参与者报告了与研究相关的严重不良事件.
- 这些发现支持使用高剂量的PPI和阿司匹林来治疗巴雷特食道并预防食道腺癌.
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