冠状动脉疾病镁治疗（MAGIC）试验中，对急性心肌梗死高危患者早期静脉注射镁：一项随机对照试验。

Early administration of intravenous magnesium to high-risk patients with acute myocardial infarction in the Magnesium in Coronaries (MAGIC) Trial: a randomised controlled trial.

出版信息

Lancet. 2002 Oct 19;360(9341):1189-96. doi: 10.1016/s0140-6736(02)11278-5.

Abstract

BACKGROUND

The benefits of supplemental administration of intravenous magnesium in patients with ST-elevation myocardial infarction (STEMI) are controversial. Despite promising results from work in animals and the ready availability of this simple, inexpensive treatment, conflicting results have been reported in clinical trials. Our aim was to compare short-term mortality in patients with STEMI who received either intravenous magnesium sulphate or placebo.

METHODS

We did a randomised, double-blind trial in 6213 patients with acute STEMI who were assigned a 2 g intravenous bolus of magnesium sulphate administered over 15 min, followed by a 17 g infusion of magnesium sulphate over 24 h (n=3113), or matching placebo (n=3100). Our primary endpoint was 30-day all-cause mortality. At randomisation, patients were stratified by their eligibility for reperfusion therapy. The first stratum included patients who were aged 65 years or older and eligible for reperfusion therapy, and the second stratum included patients of any age who were not eligible for reperfusion therapy. Analysis was by intention-to-treat.

FINDINGS

At 30 days, 475 (15.3%) patients in the magnesium group and 472 (15.2%) in the placebo group had died (odds ratio 1.0, 95% CI 0.9-1.2, p=0.96). No benefit or harm of magnesium was observed in eight prespecified subgroup analyses of patients and in 15 additional exploratory subgroup analyses. After adjustment for factors shown to effect mortality risk in a multivariate regression model, no benefit of magnesium was observed (1.0, 0.8-1.1, p=0.53).

INTERPRETATION

Early administration of magnesium in high-risk patients with STEMI has no effect on 30-day mortality. In view of the totality of the available evidence, in current coronary care practice there is no indication for the routine administration of intravenous magnesium in patients with STEMI.

摘要

背景

对于ST段抬高型心肌梗死（STEMI）患者补充静脉注射镁的益处存在争议。尽管在动物实验中取得了有前景的结果，且这种简单、廉价的治疗方法易于获得，但临床试验报告的结果却相互矛盾。我们的目的是比较接受静脉注射硫酸镁或安慰剂的STEMI患者的短期死亡率。

方法

我们对6213例急性STEMI患者进行了一项随机、双盲试验，这些患者被分配接受在15分钟内静脉推注2克硫酸镁，随后在24小时内输注17克硫酸镁（n = 3113），或匹配的安慰剂（n = 3100）。我们的主要终点是30天全因死亡率。在随机分组时，患者根据其接受再灌注治疗的资格进行分层。第一层包括年龄在65岁及以上且有资格接受再灌注治疗的患者，第二层包括任何年龄但无资格接受再灌注治疗的患者。分析采用意向性分析。

结果

在30天时，镁组有475例（15.3%）患者死亡，安慰剂组有472例（15.2%）患者死亡（优势比1.0，95%置信区间0.9 - 1.2，p = 0.96）。在对患者进行的八项预先指定的亚组分析以及另外15项探索性亚组分析中，均未观察到镁的有益或有害作用。在多变量回归模型中对显示影响死亡风险的因素进行调整后，未观察到镁的益处（1.0，0.8 - 1.1，p = 0.53）。