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心肌梗死合并或不合并糖尿病患者的氧疗:来自 DETO2X-AMI 试验的预先设定亚组分析。

Oxygen Therapy in Myocardial Infarction Patients With or Without Diabetes: A Predefined Subgroup Analysis From the DETO2X-AMI Trial.

机构信息

Division of Endocrinology, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.

Cardiology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.

出版信息

Diabetes Care. 2019 Nov;42(11):2032-2041. doi: 10.2337/dc19-0590. Epub 2019 Aug 31.

Abstract

OBJECTIVE

To determine the effects of oxygen therapy in myocardial infarction (MI) patients with and without diabetes.

RESEARCH DESIGN AND METHODS

In the Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6-12 h or ambient air. In this prespecified analysis involving 5,010 patients with confirmed MI, 934 had known diabetes. Oxidative stress may be of particular importance in diabetes, and the primary objective was to study the effect of supplemental oxygen on the composite of all-cause death and rehospitalization with MI or heart failure (HF) at 1 year in patients with and without diabetes.

RESULTS

As expected, event rates were significantly higher in patients with diabetes compared with patients without diabetes (main composite end point: hazard ratio [HR] 1.60 [95% CI 1.32-1.93], < 0.01). In patients with diabetes, the main composite end point occurred in 16.2% (72 of 445) allocated to oxygen as compared with 16.6% (81 of 489) allocated to ambient air (HR 0.93 [95% CI 0.67-1.27], = 0.81). There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year. Likewise, corresponding end points in patients without diabetes were similar between the treatment groups.

CONCLUSIONS

Despite markedly higher event rates in patients with MI and diabetes, oxygen therapy did not significantly affect 1-year all-cause death, cardiovascular death, or rehospitalization with MI or HF, irrespective of underlying diabetes, in line with the results of the entire study.

摘要

目的

确定伴有和不伴有糖尿病的心肌梗死(MI)患者氧疗的效果。

研究设计和方法

在可疑急性心肌梗死中氧作用的确定(DETO2X-AMI)试验中,将 6629 名氧合正常的疑似 MI 患者随机分为 6-12 小时接受 6 L/min 氧疗或吸入环境空气。在这项涉及 5010 例确诊 MI 的预设分析中,934 例患者已知患有糖尿病。氧化应激在糖尿病中可能尤为重要,主要目的是研究补充氧对伴有和不伴有糖尿病的患者 1 年时全因死亡和因 MI 或心力衰竭(HF)再住院复合终点的影响。

结果

与不伴有糖尿病的患者相比,患有糖尿病的患者的事件发生率明显更高(主要复合终点:风险比[HR]1.60[95%CI 1.32-1.93],<0.01)。在患有糖尿病的患者中,与吸入环境空气相比,接受氧疗的患者主要复合终点发生率为 16.2%(445 例中的 72 例),而吸入环境空气的患者为 16.6%(489 例中的 81 例)(HR 0.93[95%CI 0.67-1.27],=0.81)。在 1 年时,复合终点的各个组成部分或心血管死亡的发生率均无统计学显著差异。同样,在不伴有糖尿病的患者中,两组之间的相应终点也相似。

结论

尽管伴有糖尿病的 MI 患者的事件发生率明显更高,但氧疗并未显著影响 1 年全因死亡、心血管死亡或因 MI 或 HF 再住院,与整个研究的结果一致。

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