Silvetti Simona, Greco Teresa, Di Prima Ambra Licia, Mucchetti Marta, de Lurdes Castro Maria, Pasin Laura, Scandroglio Mara, Landoni Giovanni, Zangrillo Alberto
Department of Anesthesia and Intensive Care, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Clin Res Cardiol. 2014 Jul;103(7):505-13. doi: 10.1007/s00392-013-0649-z. Epub 2013 Dec 25.
Standard inotropic treatment is often necessary in end-stage heart failure but may be harmful. We performed a meta-analysis of randomized controlled trials to investigate the effect of repeated administration of levosimendan on survival in patients with chronic heart failure.
Four investigators independently searched in CENTRAL, Google Scholar MEDLINE/PubMed, Scopus and the Cochrane Central Register of clinical trials to identify any randomized study ever performed with intermittent levosimendan intravenous administration in adult patients with chronic heart failure with no restrictions on dose or time of administration. Data from a total of 326 patients from six randomized controlled studies using intermittent levosimendan in a cardiological setting were included in the analysis. Levosimendan was associated with a significant reduction in mortality at the longest follow-up available [32 of 168 (19 %) in the levosimendan group 46 of 133 (35 %) in the control arm, RR = 0.55 (95 % CI 0.37-0.84), p for effect = 0 0.005, p for heterogeneity = 0.3, I (2) = 23.4 %, NNT = 6 with 5 studies included]. Brain natriuretic peptide values, ejection fraction and number of patients with New York Heart Association ≥ III status were similar in survivors of both groups.
A large randomized trial is necessary to confirm the promising beneficial effects of intermittent levosimendan administration on the mid-term survival of patients with chronic heart failure.
在终末期心力衰竭中,标准的正性肌力药物治疗往往是必要的,但可能有害。我们进行了一项随机对照试验的荟萃分析,以研究重复给予左西孟旦对慢性心力衰竭患者生存率的影响。
四位研究者独立检索了CENTRAL、谷歌学术、MEDLINE/PubMed、Scopus以及Cochrane临床试验注册中心,以确定在成年慢性心力衰竭患者中进行的任何间歇性静脉注射左西孟旦的随机研究,对剂量和给药时间没有限制。分析纳入了六项在心脏病学环境中使用间歇性左西孟旦的随机对照研究中的326例患者的数据。在最长随访期,左西孟旦与死亡率显著降低相关[左西孟旦组168例中有32例(19%),对照组133例中有46例(35%),RR = 0.55(95%CI 0.37 - 0.84),效应p值 = 0.005,异质性p值 = 0.3,I² = 23.4%,纳入5项研究时NNT = 6]。两组幸存者的脑钠肽值、射血分数以及纽约心脏协会心功能分级≥III级的患者数量相似。
有必要进行一项大型随机试验,以证实间歇性给予左西孟旦对慢性心力衰竭患者中期生存的有益作用。