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钙剂与安慰剂对院外心脏骤停患者长期结局的影响。

Effect of calcium vs. placebo on long-term outcomes in patients with out-of-hospital cardiac arrest.

机构信息

Prehospital Emergency Medical Services, Central Denmark Region, Aarhus, Denmark.

Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.

出版信息

Resuscitation. 2022 Oct;179:21-24. doi: 10.1016/j.resuscitation.2022.07.034. Epub 2022 Jul 30.

Abstract

OBJECTIVE

The Calcium for Out-of-hospital Cardiac Arrest (COCA) trial was a randomized, placebo-controlled, double-blind trial of calcium for out-of-hospital cardiac arrest. The primary and secondary outcomes have been reported previously. This article describes the long-term outcomes of the trial.

METHODS

Patients aged ≥18 years were included if they had a non-traumatic out-of-hospital cardiac arrest during which they received adrenaline. The trial drug consisted of calcium chloride (5 mmol) or saline placebo given after the first dose of adrenaline and again after the second dose of adrenaline for a maximum of two doses. This article presents pre-specified analyses of 6-month and 1-year outcomes for survival, survival with a favorable neurological outcome (modified Rankin Scale of 3 or less), and health-related quality of life.

RESULTS

A total of 391 patients were analyzed. At 1 year, 9 patients (4.7%) were alive in the calcium group while 18 (9.1%) were alive in the placebo group (risk ratio 0.51; 95% confidence interval 0.24, 1.09). At 1 year, 7 patients (3.6%) were alive with a favorable neurological outcome in the calcium group while 17 (8.6%) were alive with a favorable neurological outcome in the placebo group (risk ratio 0.42; 95% confidence interval 0.18, 0.97). Outcomes for health-related quality of life likewise suggested harm of calcium but results were imprecise with wide confidence intervals.

CONCLUSIONS

Effect estimates remained constant over time suggesting harm of calcium but with wide confidence intervals. The results do not support calcium administration during out-of-hospital cardiac arrest.

TRIAL REGISTRATION

ClinicalTrials.gov-number, NCT04153435.

摘要

目的

院外心脏骤停中的钙(COCA)试验是一项针对院外心脏骤停中钙的随机、安慰剂对照、双盲试验。主要和次要结果先前已经报道过。本文描述了该试验的长期结果。

方法

如果患者在非创伤性院外心脏骤停期间接受肾上腺素治疗,且年龄≥18 岁,则将其纳入研究。试验药物由氯化钙(5mmol)或生理盐水安慰剂组成,在首次肾上腺素剂量后和第二次肾上腺素剂量后最多给予两次。本文介绍了预先指定的 6 个月和 1 年生存、生存且神经功能良好(改良 Rankin 量表 3 分或更低)以及健康相关生活质量的分析结果。

结果

共分析了 391 例患者。在 1 年时,钙组有 9 例(4.7%)患者存活,而安慰剂组有 18 例(9.1%)患者存活(风险比 0.51;95%置信区间 0.24,1.09)。在 1 年时,钙组有 7 例(3.6%)患者存活且神经功能良好,而安慰剂组有 17 例(8.6%)患者存活且神经功能良好(风险比 0.42;95%置信区间 0.18,0.97)。健康相关生活质量的结果同样表明钙有危害,但结果不精确,置信区间较宽。

结论

随着时间的推移,效应估计值保持不变,表明钙有危害,但置信区间较宽。这些结果不支持在院外心脏骤停期间给予钙。

试验注册

ClinicalTrials.gov 编号,NCT04153435。

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