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血管加压素和甲泼尼龙与安慰剂对院内心脏骤停患者长期结局的影响:一项随机临床试验。

Effect of vasopressin and methylprednisolone vs. placebo on long-term outcomes in patients with in-hospital cardiac arrest a randomized clinical trial.

机构信息

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

Research Center for Emergency Medicine, Department of Clinical Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.

出版信息

Resuscitation. 2022 Jun;175:67-71. doi: 10.1016/j.resuscitation.2022.04.017. Epub 2022 Apr 28.

Abstract

OBJECTIVE

The primary results from the Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest (VAM-IHCA) trial have previously been reported. The objective of the current manuscript is to report long-term outcomes.

METHODS

The VAM-IHCA trial was a multicenter, randomized, double-blind, placebo-controlled trial conducted at ten hospitals in Denmark. Adult patients (age ≥ 18 years) were eligible for the trial if they had an in-hospital cardiac arrest and received at least one dose of epinephrine during resuscitation. The trial drugs consisted of 40 mg methylprednisolone (Solu-Medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of epinephrine. This manuscript report outcomes at 6 months and 1 year including survival, survival with favorable neurological outcome, and health-related quality of life.

RESULTS

501 patients were included in the analysis. At 1 year, 15 patients (6.3%) in the intervention group and 22 patients (8.3%) in the placebo group were alive corresponding to a risk ratio of 0.76 (95% CI, 0.41-1.41). A favorable neurologic outcome at 1 year, based on the Cerebral Performance Category score, was observed in 14 patients (5.9%) in the intervention group and 20 patients (7.6%) in the placebo group (risk ratio, 0.78 [95% CI, 0.41-1.49]. No differences existed between groups for favorable neurological outcome and health-related quality of life at either 6 months or 1 year.

CONCLUSIONS

Administration of vasopressin and methylprednisolone, compared with placebo, in patients with in-hospital cardiac arrest did not improve long-term outcomes in this trial.

摘要

目的

先前已经报道过血管加压素和甲基强的松龙用于院内心脏骤停(VAM-IHCA)试验的主要结果。本研究报告的目的是报告长期结果。

方法

VAM-IHCA 试验是一项在丹麦 10 家医院进行的多中心、随机、双盲、安慰剂对照试验。如果成年患者(年龄≥18 岁)在院内心脏骤停,并且在复苏过程中至少接受了一次肾上腺素治疗,则有资格参加该试验。试验药物包括 40mg 甲基强的松龙(Solu-Medrol®,辉瑞)和 20IU 血管加压素(Empressin®,Amomed Pharma GmbH),在第一次肾上腺素治疗后尽快给予。本报告报告了 6 个月和 1 年的结果,包括生存率、生存伴有良好神经功能结局和健康相关生活质量。

结果

501 例患者纳入分析。在 1 年时,干预组有 15 例(6.3%)患者和安慰剂组有 22 例(8.3%)患者存活,相应的风险比为 0.76(95%CI,0.41-1.41)。根据脑功能分类评分,1 年后干预组有 14 例(5.9%)患者和安慰剂组有 20 例(7.6%)患者存在良好的神经功能结局,风险比为 0.78(95%CI,0.41-1.49)。在 6 个月或 1 年时,两组在良好的神经功能结局和健康相关生活质量方面均无差异。

结论

与安慰剂相比,血管加压素和甲基强的松龙在院内心脏骤停患者中的应用并未改善该试验的长期结果。

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