Unverzagt Susanne, Wachsmuth Lisa, Hirsch Katharina, Thiele Holger, Buerke Michael, Haerting Johannes, Werdan Karl, Prondzinsky Roland
Institute of Medical Epidemiology, Biostatistics and Informatics, Martin Luther University Halle-Wittenberg, Magdeburge Straße 8, Halle/Saale, Germany, 06097.
Cochrane Database Syst Rev. 2014 Jan 2(1):CD009669. doi: 10.1002/14651858.CD009669.pub2.
The recently published German-Austrian S3 Guideline for the treatment of infarct related cardiogenic shock (CS) revealed a lack of evidence for all recommended therapeutic measures.
To determine the effects in terms of efficacy, efficiency and safety of cardiac care with inotropic agents and vasodilator strategies versus placebo or against each other for haemodynamic stabilisation following surgical treatment, interventional therapy (angioplasty, stent implantation) and conservative treatment (that is no revascularization) on mortality and morbidity in patients with acute myocardial infarction (AMI) complicated by CS or low cardiac output syndrome (LCOS).
We searched CENTRAL, MEDLINE (Ovid), EMBASE (Ovid) and ISI Web of Science, registers of ongoing trials and proceedings of conferences in January 2013. Reference lists were scanned and experts in the field were contacted to obtain further information. No language restrictions were applied.
Randomised controlled trials in patients with AMI complicated by CS or LCOS.
Data collection and analysis were performed according to the published protocol. All trials were analysed individually. Hazard ratios (HRs) and odds ratios with 95% confidence intervals (CI) were extracted but not pooled because of high heterogeneity between the control group interventions.
Four eligible, very small studies were identified from a total of 4065 references. Three trials with high overall risk of bias compared levosimendan to standard treatment (enoximone or dobutamine) or placebo. Data from a total of 63 participants were included in our comparisons, 31 were treated with levosimendan and 32 served as controls. Levosimendan showed an imprecise survival benefit in comparison with enoximone based on a very small trial with 32 participants (HR 0.33; 95% CI 0.11 to 0.97). Results from the other similarly small trials were too imprecise to provide any meaningful information about the effect of levosimendan in comparison with dobutamine or placebo. Only small differences in haemodynamics, length of hospital stay and the frequency of major adverse cardiac events or adverse events overall were found between study groups.Only one small randomised controlled trial with three participants was found for vasodilator strategies (nitric oxide gas versus placebo) in AMI complicated by CS or LCOS. This study was too small to draw any conclusions on the effects on our key outcomes.
AUTHORS' CONCLUSIONS: At present there are no robust and convincing data to support a distinct inotropic or vasodilator drug based therapy as a superior solution to reduce mortality in haemodynamically unstable patients with CS or low cardiac output complicating AMI.
最近发表的德国 - 奥地利关于梗死相关心源性休克（CS）治疗的S3指南显示，所有推荐的治疗措施均缺乏证据支持。
确定在急性心肌梗死（AMI）合并CS或低心输出量综合征（LCOS）的患者中，在手术治疗、介入治疗（血管成形术、支架植入）和保守治疗（即无血运重建）后，使用正性肌力药物和血管扩张剂策略进行心脏护理与安慰剂相比或相互之间在血流动力学稳定方面对死亡率和发病率的疗效、效率及安全性的影响。
我们检索了Cochrane系统评价数据库、MEDLINE（Ovid）、EMBASE（Ovid）和ISI科学网，检索了2013年1月正在进行的试验登记和会议记录。扫描了参考文献列表并联系了该领域的专家以获取更多信息。未设语言限制。
AMI合并CS或LCOS患者的随机对照试验。
根据已发表的方案进行数据收集和分析。所有试验均单独分析。提取了风险比（HRs）和比值比及其95%置信区间（CI），但由于对照组干预措施之间存在高度异质性，未进行汇总。
从总共4065篇参考文献中确定了4项符合条件的、规模非常小的研究。3项整体偏倚风险高的试验将左西孟旦与标准治疗（依诺昔酮或多巴酚丁胺）或安慰剂进行了比较。我们的比较纳入了总共63名参与者的数据，31名接受左西孟旦治疗，32名作为对照。基于一项仅有32名参与者的非常小的试验，与依诺昔酮相比，左西孟旦显示出不确切的生存获益（HR 0.33；95%CI 0.11至0.97）。其他类似的小规模试验结果过于不确切，无法提供关于左西孟旦与多巴酚丁胺或安慰剂相比效果的任何有意义信息。研究组之间在血流动力学、住院时间以及主要不良心脏事件或总体不良事件的发生率方面仅发现了微小差异。在AMI合并CS或LCOS中，仅发现一项有3名参与者的小型随机对照试验用于血管扩张剂策略（一氧化氮气体与安慰剂）。这项研究规模太小，无法就其对我们关键结局的影响得出任何结论。
目前尚无有力且令人信服的数据支持以特定的正性肌力或血管扩张剂药物为基础的治疗作为降低AMI合并血流动力学不稳定的CS或低心输出量患者死亡率的更优解决方案。
