糖尿病患者心肌梗塞后的多种维生素:一项随机临床试验
Francisco Ujueta1, Gervasio A Lamas2, Kevin J Anstrom3
1Brigham and Women's Hospital Division of Cardiovascular Medicine, Boston, Massachusetts.
JAMA internal medicine
|March 3, 2025
概括
口服多种维生素和多种矿物质 (OMVMs) 并没有减少糖尿病患者和先前心肌梗塞 (MI) 的心血管事件. 高剂量的OMVM,单独或与EDTA合,在这个患者群体中没有益处.
科学领域:
- 心血管医学 心血管医学
- 临床试验 临床试验
- 营养科学 营养科学
背景情况:
- 评估化疗法试验 (TACT) 之前研究了口服多维生素和多矿物质 (OMVMs) 与EDTA化疗法.
- 之前的TACT发现表明,虽然单独使用OMVMs并没有减少心血管事件,但活性EDTA与活性OMVMs相结合显示出优于安慰剂的优势.
研究的目的:
- 评估口服多种维生素和多种矿物质 (OMVMs) 与安慰剂相比在减少主要心血管不良事件方面的疗效.
- 评估OMVMs在糖尿病患者和心肌梗塞 (MI) 病史患者的效果.
主要方法:
- 一个随机的,多中心的,双面罩的,2x2因子临床试验 (TACT2) 涉及1000名年龄在50岁或以上的参与者,患有糖尿病和先前的MI.
- 参与者接受了活性OMVM或安慰剂OMVM,以及活性EDTA合剂或安慰剂输液.
- 主要终点是所有原因死亡率,心脏病发作,中风,冠状动脉再血管化或因心痛不稳定而住院的复合结果.
主要成果:
- 在活性OMVM组和安慰剂OMVM组之间没有观察到主要终点的显著差异 (危险比率[HR],0.99 [95% CI,0.80-1.22];P=.92).
- 与安慰剂输注和安慰剂OMVM相比,EDTA合和活性OMVM的组合并没有显著减少心血管事件 (HR,0.91 [95%CI,0.67-1.23];P=.54).
- 与安慰剂OMVM组相比,在活跃的OMVM组中观察到MI,中风和心血管死亡率的数量较高,尽管这在统计学上并不显著.
结论:
- 高剂量的口服多种维生素和多种矿物质 (OMVMs),单独或与基于EDTA的合剂一起使用,在患有慢性冠状动脉疾病,糖尿病和先前心肌梗塞的患者中没有显示出降低心血管事件的有效性.
- 这些发现表明,OMVMs在预防这种特定高风险人群中主要的不良心血管事件方面没有好处.
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