Pauline van Gils, Sjoukje Nutma, Karen Meeske, Caroline van Heugten, Walter van den Bergh, Norbert Foudraine, Joost le Feber, Margreet Filius, Michel van Putten, Bert Beishuizen, Jeannette Hofmeijer
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引用次数: 0
Abstract
Aims: Effective treatments to improve brain recovery after cardiac arrest are needed. Ghrelin showed efficacy in experimental models and was associated with lower neuron-specific enolase levels in the clinical Ghrelin in Coma (GRECO) trial. Here, we present cognitive and psychosocial outcomes at 1-year follow-up.
Methods and results: GRECO was a Phase 2 multicentre, double-blind, randomized, placebo-controlled trial in comatose patients after cardiac arrest. The intervention was intravenous acyl-ghrelin 600 μg twice daily or placebo for 1 week, starting within 12 h after the arrest. Patients were assessed after 1 year using cognitive tests and questionnaires measuring participation, health-related quality of life, mood, and caregiver strain. Composite z-scores of the cognitive tests were computed by comparing the scores with those of a norm population and averaging the tests for memory, attention, and executive functioning separately. Groups were compared based on composite z-scores and cut-off scores for psychosocial outcomes. Of the 160 participants originally included, 66 of the 85 participants who survived to 1 year after OHCA completed the psychosocial and cognitive follow-up. The intervention group scored numerically higher across the cognitive domains compared with the control group, but the differences were not statistically significant (memory median = -0.850 vs. -1.385, U = 424.5, P = 0.587; attention median = -0.733 vs. -0.717, U = 420.5, P = 0.548; and executive functioning median = -0.311 vs. -0.482, U = 408.5, P = 0.323). There were significantly fewer signs of depression in the intervention group (U = 322.5, P = 0.014).
Conclusion: This predefined secondary analysis found that ghrelin treatment was associated with non-significantly but consistently better cognitive outcomes and significantly fewer signs of depression. This is in line with the primary outcomes.
背景：需要有效的治疗方法来改善心脏骤停后的大脑恢复。格列林在实验模型中显示出疗效，在昏迷中使用格列林的临床试验（GRECO）中，格列林与降低神经元特异性烯醇化酶水平有关。我们在此介绍随访一年的认知和社会心理结果：GRECO 是一项针对心脏骤停后昏迷患者的多中心、双盲、随机、安慰剂对照试验。干预措施是在心跳骤停后 12 小时内开始静脉注射酰化格列林 600 μg 或安慰剂，每天两次，持续一周。一年后，使用认知测试和调查问卷对患者进行评估，调查内容包括参与度、与健康相关的生活质量、情绪和照顾者的压力。通过与常模人群的得分进行比较，并分别对记忆力、注意力和执行功能测试进行平均，计算出认知测试的综合 Z 值。根据综合 Z 值和社会心理结果的临界值对各组进行比较：在最初纳入的 160 名参与者中，有 85 人在 OHCA 一年后存活下来，其中 66 人完成了社会心理和认知方面的随访。与对照组相比，干预组在所有认知领域的得分都较高，但差异无统计学意义（记忆中位数 = -.850 vs. -1.385, U = 424.5, p = .587；注意力中位数 = -.733 vs. -.717, U = 420.5, p = .548；执行功能中位数 = -.311 vs. -.369, U = 408.5, p = .323）。干预组的抑郁迹象明显减少，U = 322.5，p = .014：这项预先定义的二次分析发现，胃泌素治疗与认知结果的改善无显著相关性，但却具有一致性，而且抑郁迹象明显减少。这与主要结果一致：试验注册：Clinicaltrialsregister.eu：EUCTR2018-000005-23-NL.
期刊介绍：
The European Heart Journal - Acute Cardiovascular Care (EHJ-ACVC) offers a unique integrative approach by combining the expertise of the different sub specialties of cardiology, emergency and intensive care medicine in the management of patients with acute cardiovascular syndromes.
Reading through the journal, cardiologists and all other healthcare professionals can access continuous updates that may help them to improve the quality of care and the outcome for patients with acute cardiovascular diseases.
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