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危重症成人的体外膜肺氧合

Extracorporeal membrane oxygenation for critically ill adults.

作者信息

Tramm Ralph, Ilic Dragan, Davies Andrew R, Pellegrino Vincent A, Romero Lorena, Hodgson Carol

机构信息

Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Department of Epidemiology and Preventive Medicine, Monash University, Level 6 The Alfred Centre, 99 Commercial Road, Melbourne, Victoria, Australia, 3004.

出版信息

Cochrane Database Syst Rev. 2015 Jan 22;1(1):CD010381. doi: 10.1002/14651858.CD010381.pub2.

Abstract

BACKGROUND

Extracorporeal membrane oxygenation (ECMO) is a form of life support that targets the heart and lungs. Extracorporeal membrane oxygenation for severe respiratory failure accesses and returns blood from the venous system and provides non-pulmonary gas exchange. Extracorporeal membrane oxygenation for severe cardiac failure or for refractory cardiac arrest (extracorporeal cardiopulmonary resuscitation (ECPR)) provides gas exchange and systemic circulation. The configuration of ECMO is variable, and several pump-driven and pump-free systems are in use. Use of ECMO is associated with several risks. Patient-related adverse events include haemorrhage or extremity ischaemia; circuit-related adverse effects may include pump failure, oxygenator failure and thrombus formation. Use of ECMO in newborns and infants is well established, yet its clinical effectiveness in adults remains uncertain.

OBJECTIVES

The primary objective of this systematic review was to determine whether use of veno-venous (VV) or venous-arterial (VA) ECMO in adults is more effective in improving survival compared with conventional respiratory and cardiac support.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid) and EMBASE (Ovid) on 18 August 2014. We searched conference proceedings, meeting abstracts, reference lists of retrieved articles and databases of ongoing trials and contacted experts in the field. We imposed no restrictions on language or location of publications.

SELECTION CRITERIA

We included randomized controlled trials (RCTs), quasi-RCTs and cluster-RCTs that compared adult ECMO versus conventional support.

DATA COLLECTION AND ANALYSIS

Two review authors independently screened the titles and abstracts of all retrieved citations against the inclusion criteria. We independently reviewed full-text copies of studies that met the inclusion criteria. We entered all data extracted from the included studies into Review Manager. Two review authors independently performed risk of bias assessment. All included studies were appraised with respect to random sequence generation, concealment of allocation, blinding of outcome assessment, incomplete outcome data, selective reporting and other bias.

MAIN RESULTS

We included four RCTs that randomly assigned 389 participants with acute respiratory failure. Risk of bias was low in three RCTs and high in one RCT. We found no statistically significant differences in all-cause mortality at six months (two RCTs) or before six months (during 30 days of randomization in one trial and during hospital stay in another RCT). The quality of the evidence was low to moderate, and further research is very likely to impact our confidence in the estimate of effects because significant changes have been noted in ECMO applications and treatment modalities over study periods to the present.Two RCTs supplied data on disability. In one RCT survival was low in both groups but none of the survivors had limitations in their daily activities six months after discharge. The other RCT reported improved survival without severe disability in the intervention group (transfer to an ECMO centre ± ECMO) six months after study randomization but no statistically significant differences in health-related quality of life.In three RCTs, participants in the ECMO group received greater numbers of blood transfusions. One RCT recorded significantly more non-brain haemorrhage in the ECMO group. Another RCT reported two serious adverse events in the ECMO group, and another reported three adverse events in the ECMO group.Clinical heterogeneity between studies prevented meta-analyses across outcomes. We found no completed RCT that had investigated ECMO in the context of cardiac failure or arrest. We found one ongoing RCT that examined patients with acute respiratory failure and two ongoing RCTs that included patients with acute cardiac failure (arrest).

AUTHORS' CONCLUSIONS: Extracorporeal membrane oxygenation remains a rescue therapy. Since the year 2000, patient treatment and practice with ECMO have considerably changed as the result of research findings and technological advancements over time. Over the past four decades, only four RCTs have been published that compared the intervention versus conventional treatment at the time of the study. Clinical heterogeneity across these published studies prevented pooling of data for a meta-analysis.We recommend combining results of ongoing RCTs with results of trials conducted after the year 2000 if no significant shifts in technology or treatment occur. Until these new results become available, data on use of ECMO in patients with acute respiratory failure remain inconclusive. For patients with acute cardiac failure or arrest, outcomes of ongoing RCTs will assist clinicians in determining what role ECMO and ECPR can play in patient care.

摘要

背景

体外膜肺氧合(ECMO)是一种针对心脏和肺部的生命支持形式。用于严重呼吸衰竭的体外膜肺氧合从静脉系统获取血液并将其回输,提供非肺气体交换。用于严重心力衰竭或难治性心脏骤停(体外心肺复苏(ECPR))的体外膜肺氧合提供气体交换和体循环。ECMO的配置多种多样,有几种泵驱动和无泵系统正在使用。ECMO的使用伴随着多种风险。与患者相关的不良事件包括出血或肢体缺血;与回路相关的不良反应可能包括泵故障、氧合器故障和血栓形成。ECMO在新生儿和婴儿中的应用已得到充分确立,但其在成人中的临床有效性仍不确定。

目的

本系统评价的主要目的是确定在成人中使用静脉 - 静脉(VV)或静脉 - 动脉(VA)ECMO与传统呼吸和心脏支持相比,在提高生存率方面是否更有效。

检索方法

我们于2014年8月18日检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE(Ovid)和EMBASE(Ovid)。我们检索了会议论文集、会议摘要、检索文章的参考文献列表以及正在进行的试验数据库,并联系了该领域的专家。我们对出版物的语言或地点没有限制。

选择标准

我们纳入了比较成人ECMO与传统支持的随机对照试验(RCT)、准RCT和整群RCT。

数据收集与分析

两位综述作者根据纳入标准独立筛选所有检索到的文献的标题和摘要。我们独立审查符合纳入标准的研究的全文副本。我们将从纳入研究中提取的所有数据录入Review Manager。两位综述作者独立进行偏倚风险评估。所有纳入研究均就随机序列生成、分配隐藏、结果评估的盲法、不完整的结果数据、选择性报告和其他偏倚进行了评估。

主要结果

我们纳入了四项RCT,共随机分配了389名急性呼吸衰竭患者。三项RCT的偏倚风险较低,一项RCT的偏倚风险较高。我们发现在六个月时(两项RCT)或六个月前(一项试验在随机化的30天内,另一项RCT在住院期间)全因死亡率无统计学显著差异。证据质量为低到中等,由于从研究期间到现在ECMO应用和治疗方式已发生显著变化,进一步的研究很可能会影响我们对效应估计的信心。两项RCT提供了关于残疾的数据。在一项RCT中,两组的生存率都很低,但出院六个月后所有幸存者的日常活动均无受限。另一项RCT报告在研究随机化六个月后,干预组(转至ECMO中心±使用ECMO)的生存率提高且无严重残疾,但健康相关生活质量无统计学显著差异。在三项RCT中,ECMO组的参与者接受输血的次数更多。一项RCT记录到ECMO组非脑内出血明显更多。另一项RCT报告ECMO组有两起严重不良事件,另一项报告ECMO组有三起不良事件。研究之间的临床异质性妨碍了对各项结果进行荟萃分析。我们未发现有已完成的RCT在心力衰竭或心脏骤停背景下研究ECMO。我们发现一项正在进行的RCT研究急性呼吸衰竭患者,两项正在进行的RCT纳入急性心力衰竭(心脏骤停)患者。

作者结论

体外膜肺氧合仍然是一种抢救治疗方法。自2000年以来,随着时间推移研究结果和技术进步,患者的ECMO治疗和实践有了很大变化。在过去四十年中,仅发表了四项RCT,比较了研究当时的干预措施与传统治疗。这些已发表研究之间的临床异质性妨碍了汇总数据进行荟萃分析。如果技术或治疗没有重大变化,我们建议将正在进行的RCT结果与2000年后进行的试验结果相结合。在这些新结果出来之前,关于ECMO在急性呼吸衰竭患者中使用的数据仍然没有定论。对于急性心力衰竭或心脏骤停患者,正在进行的RCT结果将帮助临床医生确定ECMO和ECPR在患者护理中可以发挥的作用。

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