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高浓度与滴定氧疗治疗 ST 段抬高型心肌梗死:一项初步随机对照试验。

High-concentration versus titrated oxygen therapy in ST-elevation myocardial infarction: a pilot randomized controlled trial.

机构信息

Capital & Coast District Health Board, Wellington, New Zealand.

出版信息

Am Heart J. 2012 Feb;163(2):168-75. doi: 10.1016/j.ahj.2011.10.013. Epub 2012 Jan 13.

DOI:10.1016/j.ahj.2011.10.013
PMID:22305833
Abstract

BACKGROUND

The optimal approach to oxygen therapy in ST-elevation myocardial infarction (STEMI) is uncertain.

METHODS

A randomized controlled trial was undertaken in which 136 patients presenting with their first STEMI uncomplicated by cardiogenic shock or marked hypoxia were randomized to receive high-concentration (6 L/min via medium concentration mask) or titrated oxygen (to achieve oxygen saturation 93%-96%) for 6 hours after presentation. The main outcome variables were 30-day mortality and infarct size assessed by troponin T level at 72 hours. Secondary outcomes included a meta-analysis of mortality data from this study and previous randomized controlled trials, and infarct size was assessed by magnetic resonance imaging at 4 to 6 weeks.

RESULTS

There were 1 of 68 and 2 of 68 deaths in the high-concentration and titrated oxygen groups, respectively; a meta-analysis including these data with those from the 2 previous studies showed an odds ratio for mortality of high-concentration oxygen compared with room air or titrated oxygen of 2.2 (95% CI 0.8-6.0). There was no significant difference between high-concentration versus titrated oxygen in troponin T (ratio of mean levels 0.74, 95% CI 0.50-1.1, P = .14), infarct mass (mean difference -0.8 g, 95% CI -7.6 to 6.1, P = .82), or percent infarct mass (mean difference -0.6%, 95% CI -5.6 to 4.5, P = .83).

CONCLUSION

This study found no evidence of benefit or harm from high-concentration compared with titrated oxygen in initially uncomplicated STEMI. However, our estimates have wide CIs, and as a result, large randomized controlled trials are required to resolve the clinical uncertainty.

摘要

背景

ST 段抬高型心肌梗死(STEMI)患者的最佳氧疗方法尚不确定。

方法

本研究为一项随机对照试验,共纳入 136 例初次就诊且未发生心源性休克或明显低氧血症的 STEMI 患者,随机分为高浓度组(通过中浓度面罩给予 6 L/min 的氧气)和滴定氧组(将氧饱和度维持在 93%-96%),两组患者均在就诊后 6 小时内接受相应的氧疗。主要观察终点为 30 天死亡率和 72 小时肌钙蛋白 T 水平评估的梗死面积。次要观察终点包括对本研究和既往随机对照试验的死亡率数据进行的 meta 分析,以及 4-6 周时采用磁共振成像评估梗死面积。

结果

高浓度组和滴定氧组分别有 1 例(1.5%)和 2 例(3.0%)患者死亡;meta 分析纳入了本研究和既往 2 项研究的数据,结果显示与空气或滴定氧相比,高浓度氧治疗的死亡风险比为 2.2(95%CI 0.8-6.0)。高浓度氧组和滴定氧组在肌钙蛋白 T(平均水平比值为 0.74,95%CI 0.50-1.1,P=0.14)、梗死面积(平均差值为-0.8 g,95%CI -7.6 至 6.1,P=0.82)和梗死面积比例(平均差值为-0.6%,95%CI -5.6 至 4.5,P=0.83)方面均无显著差异。

结论

本研究未发现与滴定氧相比,高浓度氧治疗初次就诊且未发生并发症的 STEMI 患者可带来获益或危害。然而,我们的估计值置信区间较宽,因此需要开展大规模随机对照试验以解决这一临床不确定性问题。

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