目标温度管理在 33°C 与 36°C 时对院外心脏骤停后患者的神经功能和健康相关生活质量的影响：一项随机临床试验。

Neurologic Function and Health-Related Quality of Life in Patients Following Targeted Temperature Management at 33°C vs 36°C After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial.

机构信息

Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden2Department of Clinical Sciences, Lund University, Lund, Sweden.

Department of Intensive Care, Academic Medical Center, Amsterdam, the Netherlands.

出版信息

JAMA Neurol. 2015 Jun;72(6):634-41. doi: 10.1001/jamaneurol.2015.0169.

DOI:10.1001/jamaneurol.2015.0169

PMID:25844993

Abstract

IMPORTANCE

Brain injury affects neurologic function and quality of life in survivors after cardiac arrest.

OBJECTIVE

To compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest.

DESIGN, SETTING, AND PARTICIPANTS: In this multicenter, international, parallel group, assessor-masked randomized clinical trial performed from November 11, 2010, through January 10, 2013, we enrolled 950 unconscious adults with cardiac arrest of presumed cardiac cause from 36 intensive care units in Europe and Australia. Eleven patients were excluded from analysis for a total sample size of 939.

INTERVENTIONS

Targeted temperature management at 33°C vs 36°C.

MAIN OUTCOMES AND MEASURES

Cognitive function was measured by the Mini-Mental State Examination (MMSE) and assessed by observers through the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Patients reported their activities in daily life and mental recovery through Two Simple Questions and their quality of life through the Medical Outcomes Study 36-Item Short Form Health Survey, version 2.

RESULTS

In the modified intent-to-treat population, including nonsurvivors, the median MMSE score was 14 in the 33°C group (interquartile range [IQR], 0-28) vs 17 in the 36°C group (IQR, 0-29) (P = .77), and the IQCODE score was 115 (IQR, 79-130) vs 115 (IQR, 80-130) (P = .57) in the 33°C and 36°C groups, respectively. The median MMSE score for survivors was within the reference range and similar (33°C group median, 28; IQR, 26-30; vs 36°C group median, 28; IQR, 25-30; P = .61). The median IQCODE score was within the minor deficit range (33°C group median, 79.5; IQR, 78.0-85.9; vs 36°C group median, 80.7; IQR, 78.0-86.9; P = .04). A total of 18.8% vs 17.5% of survivors reported needing help with everyday activities (P = .71), and 66.5% in the 33°C group vs 61.8% in the 36°C group reported that they thought they had made a complete mental recovery (P = .32). The mean (SD) mental component summary score was 49.1 (12.5) vs 49.0 (12.2) (P = .79), and the mean (SD) physical component summary score was 46.8 (13.8) and 47.5 (13.8) (P = .45), comparable to the population norm.

CONCLUSIONS AND RELEVANCE

Quality of life was good and similar in patients with cardiac arrest receiving targeted temperature management at 33°C or 36°C. Cognitive function was similar in both intervention groups, but many patients and observers reported impairment not detected previously by standard outcome scales.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01020916.

摘要

重要性

脑损伤会影响心脏骤停后幸存者的神经功能和生活质量。

目的

比较两种目标体温管理方案对心脏骤停后长期认知功能和生活质量的影响。

设计、地点和参与者：这是一项多中心、国际、平行组、评估者设盲的随机临床试验，于 2010 年 11 月 11 日至 2013 年 1 月 10 日进行，共纳入来自欧洲和澳大利亚 36 个重症监护病房的 950 名无意识的成人心脏骤停患者，其中 11 名患者因分析被排除，总样本量为 939 名。

干预措施

目标温度管理 33°C 与 36°C。

主要观察指标和测量方法

认知功能通过简易精神状态检查（MMSE）进行评估，通过老年认知障碍询问表（IQCODE）的知情者进行评估。患者通过两个简单的问题报告日常生活活动和精神恢复情况，通过医疗结局研究 36 项简明健康调查量表，第 2 版报告生活质量。

结果

在改良意向治疗人群中，包括非幸存者，33°C 组的 MMSE 中位数评分为 14（四分位距 [IQR]，0-28），36°C 组为 17（IQR，0-29）（P =.77），IQCODE 评分分别为 115（IQR，79-130）和 115（IQR，80-130）（P =.57）。幸存者的 MMSE 中位数评分在参考范围内且相似（33°C 组中位数 28；IQR，26-30；36°C 组中位数 28；IQR，25-30；P =.61）。IQCODE 中位数评分在轻度缺陷范围内（33°C 组中位数 79.5；IQR，78.0-85.9；36°C 组中位数 80.7；IQR，78.0-86.9；P =.04）。共有 18.8%的幸存者报告需要帮助日常生活活动，而 17.5%的幸存者报告需要帮助日常生活活动（P =.71），33°C 组中有 66.5%的幸存者认为他们已经完全康复，而 36°C 组中有 61.8%的幸存者认为他们已经完全康复（P =.32）。心理成分综合评分的平均值（SD）为 49.1（12.5）和 49.0（12.2）（P =.79），生理成分综合评分的平均值（SD）为 46.8（13.8）和 47.5（13.8）（P =.45），与人群正常值相当。