Department of Critical Care Medicine, Subei People's Hospital, School of Medicine, Yangzhou University, 98 Nantong West Road, Yangzhou, Jiangsu, 225001, People's Republic of China.
Department of Cardiology, Subei People's Hospital, School of Medicine, Yangzhou University, 98 Nantong West Road, Yangzhou, 225001, People's Republic of China.
Crit Care. 2017 Oct 17;21(1):253. doi: 10.1186/s13054-017-1848-1.
Small trials suggest that levosimendan is associated with a favorable outcome in patients undergoing cardiac surgery. However, recently published larger-scale trials did not provide evidence for a similar benefit from levosimendan. We performed a meta-analysis to assess the survival benefits of levosimendan in patients undergoing cardiac surgery and to investigate its effects in subgroups of patients with preoperative low-ejection fraction (EF).
We identified randomized clinical trials through 20 April 2017 that investigated levosimendan therapy versus control in patients undergoing cardiac surgery. Individual patient data from each study were compiled. Meta-analyses were performed for primary outcomes, secondary outcomes and serious adverse events, and subgroup analyses according to the preoperative EF of enrolled patients were also conducted. The risk of bias was assessed using the Cochrane risk-of-bias tool.
Seventeen studies involving a total of 2756 patients were included. Levosimendan therapy was associated with a significant reduction in 30-day mortality (RR 0.67; 95% CI, 0.49 to 0.93; p = 0.02) and reduced the risk of death in single-center trials (RR 0.49; 95% CI, 0.30 to 0.79; p = 0.004) and in subgroup trials of inferior quality (RR 0.39; 95% CI, 0.17 to 0.92; p = 0.02); however, in multicenter and in high-quality subgroup-analysis trials, no significant difference in mortality was observed between patients who received levosimendan therapy and controls (p > 0.05). However, in high-quality subgroup trials, levosimendan therapy was associated with reduced mortality in patients in a preoperative low-EF subgroup (RR 0.58; 95% CI, 0.38 to 0.88; p = 0.01). Similarly, only patients in the preoperative low-EF subgroup benefited in terms of reduced risk of renal replacement therapy (RR 0.54; 95% CI, 0.34 to 0.85; p = 0.007). Furthermore, levosimendan therapy was associated with a significant reduction in intensive care unit (ICU) length of stay (MDR -17.19; 95% CI, -34.43 to -2.94; p = 0.02).
In patients undergoing cardiac surgery, the benefit of levosimendan in terms of survival was not shown in multicenter or in high-quality trials; however, levosimendan therapy was associated with reduced mortality in patients with preoperative ventricular systolic dysfunction.
小型试验表明，左西孟旦可改善心脏手术患者的预后。然而，最近发表的规模更大的试验并未提供左西孟旦类似获益的证据。我们进行了一项荟萃分析，以评估左西孟旦对心脏手术患者的生存获益，并探讨其在术前射血分数（EF）较低的患者亚组中的作用。
我们通过 2017 年 4 月 20 日检索，确定了左西孟旦治疗与心脏手术患者对照治疗的随机临床试验。从每项研究中汇总了个体患者数据。对主要结局、次要结局和严重不良事件进行了荟萃分析，并根据纳入患者的术前 EF 进行了亚组分析。使用 Cochrane 偏倚风险工具评估了偏倚风险。
共纳入 17 项研究，共计 2756 例患者。左西孟旦治疗可显著降低 30 天死亡率（RR 0.67；95%CI，0.49 至 0.93；p=0.02），并降低单中心试验（RR 0.49；95%CI，0.30 至 0.79；p=0.004）和亚组试验（RR 0.39；95%CI，0.17 至 0.92；p=0.02）中死亡风险，但是在多中心和高质量亚组分析试验中，接受左西孟旦治疗的患者与对照组患者的死亡率无显著差异（p>0.05）。然而，在高质量亚组试验中，左西孟旦治疗可降低术前 EF 较低亚组患者的死亡率（RR 0.58；95%CI，0.38 至 0.88；p=0.01）。同样，只有术前 EF 较低的亚组患者在降低肾脏替代治疗风险方面获益（RR 0.54；95%CI，0.34 至 0.85；p=0.007）。此外，左西孟旦治疗可显著降低重症监护病房（ICU）住院时间（MDR -17.19；95%CI，-34.43 至 -2.94；p=0.02）。
在心脏手术患者中，多中心或高质量试验均未显示左西孟旦在生存方面的获益；然而，左西孟旦治疗可降低术前心室收缩功能障碍患者的死亡率。
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