Department of Intensive Care Medicine, Affiliated Hospital of Chengdu University, No.82, North Section 2, 2nd Ring Road, Jinniu District, Chengdu, 610081 Sichuan, China.
Department of Cardiac Surgery, Affiliated Hospital of Chengdu University, Chengdu, Sichuan, China.
Anaesth Crit Care Pain Med. 2019 Jun;38(3):243-249. doi: 10.1016/j.accpm.2018.08.005. Epub 2018 Oct 17.
Levosimendan is an inotropic agent that has been shown in small studies to treat low cardiac output syndrome in cardiac surgery. However, large randomised controlled trials (RCTs) have been recently published and presented neutral results. We sought to determine the effect of levosimendan on mortality in adults with low ejection fraction undergoing cardiac surgery. We searched different databases: Medline, Embase, Cochrane Central Register of Controlled Trials, and clinical trial registries. We included RCTs comparing events in the levosimendan versus placebo in adult patients with ejection fraction ≤ 35% undergoing cardiac surgery. Outcomes were mortality at 30-day, mortality beyond 30-day, acute kidney injury and myocardial infarction. Five trials with a total of 1519 patients were selected. Four trials were rated as low risk of bias. Our meta-analysis showed no significant difference between levosimendan versus placebo mortality at 30-day [odds radio (OR): 0.62; 95% confidence intervals (CI): 0.32 to 1.20; I = 33%; high quality evidence] and mortality beyond 30-day (OR: 0.71; 95% CI: 0.46 to 1.11; I = 0%). Similarly, there were no significant differences between the levosimendan versus placebo in the incidence of acute kidney injury (OR: 0.61, 95% CI: 0.33-1.13) and myocardial infarction (OR: 0.41, 95% CI: 0.08 to 1.22). The current evidence suggests that levosimendan is not associated with significantly reduced mortality in patients with reduced ejection fraction undergoing cardiac surgery.
左西孟旦是一种正性肌力药物，在小型研究中已显示可治疗心脏手术中的低心输出综合征。然而，最近发表了一些大型随机对照试验（RCT），结果为中性。我们旨在确定左西孟旦对接受心脏手术的射血分数降低的成年人死亡率的影响。我们在不同数据库中进行了检索：Medline、Embase、Cochrane 对照试验中心注册库和临床试验登记处。我们纳入了比较左西孟旦与安慰剂在接受心脏手术且射血分数≤35%的成年患者中的事件的 RCT。结局为 30 天死亡率、30 天后死亡率、急性肾损伤和心肌梗死。纳入了五项共 1519 例患者的试验。四项试验被评为低偏倚风险。我们的荟萃分析显示，左西孟旦与安慰剂在 30 天死亡率[比值比（OR）：0.62；95%置信区间（CI）：0.32 至 1.20；I ² = 33%；高质量证据]和 30 天后死亡率（OR：0.71；95% CI：0.46 至 1.11；I ² = 0%）方面均无显著差异。同样，左西孟旦与安慰剂在急性肾损伤（OR：0.61，95% CI：0.33-1.13）和心肌梗死（OR：0.41，95% CI：0.08 至 1.22）发生率方面也无显著差异。目前的证据表明，左西孟旦与接受心脏手术的射血分数降低的患者的死亡率降低无关。
