Delaney Anthony, Bradford Celia, McCaffrey John, Bagshaw Sean M, Lee Richard
Northern Clinical School, Faculty of Medicine, University of Sydney, Sydney, NSW, Australia.
Crit Care Resusc. 2007 Sep;9(3):290-2.
Levosimendan is a novel calcium-sensitising agent that has been proposed as a potentially valuable inotrope for the treatment of acute or decompensated severe heart failure. Early clinical trials described some improvements in surrogate haemodynamic parameters, and suggested a possible survival benefit. However, before concluding that there is a place for routine use of levosimendan in the intensive care unit, a careful appraisal of all available evidence is needed.
Two phase II clinical trials, RUSSLAN and LIDO, have shown reduced mortality when levosimendan was compared with placebo and dobutamine, respectively. The CASINO study, yet to be fully reported, also purports to show a beneficial effect of levosimendan. In contrast, the two largest studies, REVIVE and SURVIVE -- also yet to be fully reported -- show no effect of levosimendan.
The best available evidence comes from the two large clinical trials, REVIVE and SURVIVE. These studies suggest that levosimendan does not improve survival for patients with acute severe heart failure. Until their results can be fully scrutinised, and placed in the context of all available evidence, we should conclude that there is no place for levosimendan in the ICU.
左西孟旦是一种新型的钙增敏剂,已被提议作为治疗急性或失代偿性严重心力衰竭的一种潜在有价值的强心药。早期临床试验描述了一些替代血流动力学参数的改善,并提示可能有生存获益。然而,在得出左西孟旦在重症监护病房常规使用有一席之地的结论之前,需要对所有现有证据进行仔细评估。
两项II期临床试验,即RUSSLAN和LIDO,分别显示左西孟旦与安慰剂及多巴酚丁胺相比可降低死亡率。尚未完全报告的CASINO研究也声称显示了左西孟旦的有益效果。相比之下,两项最大规模的研究,即REVIVE和SURVIVE(也尚未完全报告)显示左西孟旦无效果。
现有最佳证据来自两项大型临床试验,即REVIVE和SURVIVE。这些研究表明,左西孟旦不能改善急性严重心力衰竭患者的生存率。在其结果能够得到充分审查并结合所有现有证据之前,我们应得出结论,左西孟旦在重症监护病房没有应用的空间。