左西孟旦在心脏手术后的血液动力学支持中的应用。
Levosimendan for Hemodynamic Support after Cardiac Surgery.
机构信息
From the Department of Anesthesia and Intensive Care, San Raffaele Scientific Institute (G.L., M.G.C., F.P., F.M., R. Lembo, A.M.S., T.B., A. Belletti, A.Z.), and Vita-Salute San Raffaele University (G.L., A.Z.), Milan, the Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Mater Domini Germaneto, Catanzaro (G.A., B.A., M.G.M.), the Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza (R. Lobreglio, L.B.), the Department of Cardiovascular Anesthesia and Intensive Care, Azienda Ospedaliera Ordine Mauriziano (A. Bianchi), and the Department of Surgical Sciences, University of Turin (L.B.), Turin, the Division of Cardiac Anesthesia and Intensive Care Unit, Azienda Ospedaliera di Rilievo Nazionale dei Colli-Monaldi Hospital, Naples (A.P., L.V.), Division of Cardiothoracic and Vascular Anesthesia and Intensive Care, the Department of Anesthesia and Critical Care Medicine, Azienda Ospedaliero-Universitaria Pisana, Pisa (F.G., P.B.), and the Department of Cardiothoracic and Vascular Anesthesia and Intensive Care, University Hospital Policlinico S. Orsola, Bologna (M.B.) - all in Italy; the Department of Anesthesiology and Intensive Care, State Research Institute of Circulation Pathology, Novosibirsk (V.V. Lomivorotov, V.A.B., M.N.A.), the Department of Anesthesiology and Intensive Care, State Research Institute for Complex Issues of Cardiovascular Disease, Kemerovo (E.V.G., D.L.S.), the Department of Anesthesiology and Intensive Care, Moscow Regional Clinical and Research Institute, Moscow (V.V. Likhvantsev, T.S.Z.), and the Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan (V.V.P.) - all in Russia; Federal University of Juiz de Fora, Juiz de Fora, Brazil (M.F.S.-F.); and the University of Melbourne, Melbourne, VIC, Australia (R.B.).
出版信息
N Engl J Med. 2017 May 25;376(21):2021-2031. doi: 10.1056/NEJMoa1616325. Epub 2017 Mar 21.
BACKGROUND
Acute left ventricular dysfunction is a major complication of cardiac surgery and is associated with increased mortality. Meta-analyses of small trials suggest that levosimendan may result in a higher rate of survival among patients undergoing cardiac surgery.
METHODS
We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving patients in whom perioperative hemodynamic support was indicated after cardiac surgery, according to prespecified criteria. Patients were randomly assigned to receive levosimendan (in a continuous infusion at a dose of 0.025 to 0.2 μg per kilogram of body weight per minute) or placebo, for up to 48 hours or until discharge from the intensive care unit (ICU), in addition to standard care. The primary outcome was 30-day mortality.
RESULTS
The trial was stopped for futility after 506 patients were enrolled. A total of 248 patients were assigned to receive levosimendan and 258 to receive placebo. There was no significant difference in 30-day mortality between the levosimendan group and the placebo group (32 patients [12.9%] and 33 patients [12.8%], respectively; absolute risk difference, 0.1 percentage points; 95% confidence interval [CI], -5.7 to 5.9; P=0.97). There were no significant differences between the levosimendan group and the placebo group in the durations of mechanical ventilation (median, 19 hours and 21 hours, respectively; median difference, -2 hours; 95% CI, -5 to 1; P=0.48), ICU stay (median, 72 hours and 84 hours, respectively; median difference, -12 hours; 95% CI, -21 to 2; P=0.09), and hospital stay (median, 14 days and 14 days, respectively; median difference, 0 days; 95% CI, -1 to 2; P=0.39). There was no significant difference between the levosimendan group and the placebo group in rates of hypotension or cardiac arrhythmias.
CONCLUSIONS
In patients who required perioperative hemodynamic support after cardiac surgery, low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo. (Funded by the Italian Ministry of Health; CHEETAH ClinicalTrials.gov number, NCT00994825 .).
背景
急性左心功能障碍是心脏手术的主要并发症，与死亡率增加有关。小型试验的荟萃分析表明，左西孟旦可使心脏手术后患者的生存率提高。
方法
我们进行了一项多中心、随机、双盲、安慰剂对照试验，纳入了根据预设标准在心脏手术后需要围手术期血流动力学支持的患者。患者随机接受左西孟旦（持续输注，剂量为 0.025 至 0.2μg/公斤体重/分钟）或安慰剂治疗，最长 48 小时或直至从重症监护病房（ICU）出院，此外还接受标准治疗。主要结局为 30 天死亡率。
结果
在纳入 506 例患者后，试验因无效而停止。共有 248 例患者被分配接受左西孟旦治疗，258 例患者接受安慰剂治疗。左西孟旦组和安慰剂组 30 天死亡率无显著差异（分别为 32 例[12.9%]和 33 例[12.8%]；绝对风险差异，0.1 个百分点；95%置信区间[-5.7 至 5.9]；P=0.97）。左西孟旦组与安慰剂组之间机械通气时间（中位数分别为 19 小时和 21 小时，中位数差值-2 小时；95%置信区间[-5 至 1]；P=0.48）、ICU 住院时间（中位数分别为 72 小时和 84 小时，中位数差值-12 小时；95%置信区间[-21 至 2]；P=0.09）和住院时间（中位数分别为 14 天和 14 天，中位数差值 0 天；95%置信区间[-1 至 2]；P=0.39）均无显著差异。左西孟旦组与安慰剂组之间低血压或心律失常发生率无显著差异。
结论
在心脏手术后需要围手术期血流动力学支持的患者中，与标准治疗相比，低剂量左西孟旦并未降低 30 天死亡率。（由意大利卫生部资助； CHEETAH ClinicalTrials.gov 编号，NCT00994825。）
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