维生素D补充剂对消化道癌症患者的无复发生存的影响:AMATERASU随机临床试验
Mitsuyoshi Urashima1, Hironori Ohdaira2, Taisuke Akutsu1
1Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.
JAMA
|April 10, 2019
概括
在消化道癌症患者中,术后的维生素D补充并没有显著改善无复发的生存率. 然而,一个中度25- 维生素D水平的小组显示维生素D的结果有所改善.
科学领域:
- 癌症学
- 营养科学
- 临床试验
背景情况:
- 观察性研究表明维生素D补充剂可能有助于预防二次癌症.
- 需要随机临床试验来确认维生素D对癌症患者的疗效.
研究的目的:
- 调查术后维生素D3补充剂是否能改善消化道癌症患者的生存率.
- 根据基线25-维生素D (25[OH]D) 水平分析结果.
主要方法:
- 这项AMATERASU试验是一项随机,双盲,安慰剂对照的研究.
- 417名患有消化道癌症 (I- III阶段) 的患者在术后接受了2000 IU/ 天的维生素D或安慰剂.
- 测量结果包括没有复发的生存率和总生存率,分组分析基于基线25 (OH) D水平.
主要成果:
- 维生素D补充剂没有显著改善5年无复发存活率 (77%对69%,HR 0.76,P=18) 或整体存活率 (82%对81%,HR 0.95,P=. 83).
- 在基线25~OH) D水平为20~40ng/ mL的小组观察到5年无复发存活率的显著改善 (85%对71%,HR0.46,P=.02).
- 骨折和尿路结石等不良事件在不同组中很少且相似.
结论:
- 在整个消化道癌症患者群体中,术后维生素D补充没有显著的益处.
- 维生素D补充剂可能为一小部分患者提供生存益处,这些患者的基线水平为中等的25OH) D.
- 需要进一步研究以澄清维生素D在消化道癌症治疗中的作用.
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