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【medical-news】左西孟旦在急性失代偿性心衰患者短期临床治疗中有利有弊

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Effect of Levosimendan on the Short-Term Clinical Course of Patients With Acutely Decompensated Heart Failure

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Background This study evaluated the efficacy and safety of levosimendan, a positive inotropic drug with vasodilator effects, given intravenously to patients with acutely decompensated heart failure (ADHF).

Methods We performed 2 sequential trials, the first to develop a new measure of efficacy in 100 patients, and the second to use this measure to evaluate levosimendan in an additional 600 patients. Patients admitted with ADHF received placebo or intravenous levosimendan for 24 h in addition to standard treatment. The primary endpoint was a composite that evaluated changes in clinical status during the first 5 days after randomization.

Results In the 600-patient trial, more levosimendan than placebo patients (58 vs. 44) were improved at all 3 pre-specified time points (6 h, 24 h, and 5 days), whereas fewer levosimendan patients (58 vs. 82) experienced clinical worsening (p = 0.015 for the difference between the groups). These differences were apparent, despite more frequent intensification of adjunctive therapy in the placebo group (79 vs. 45 patients). Improvements in patient self-assessment and declines in B-type natriuretic peptide levels with levosimendan persisted for 5 days and were associated with reduced length of stay (p = 0.009). Similar findings were present in the 100-patient pilot trial. Levosimendan was associated with more frequent hypotension and cardiac arrhythmias during the infusion period and a numerically higher risk of death across the 2 trials (49 of 350 on a regimen of levosimendan vs. 40 of 350 on a regimen of placebo at 90 days, p = 0.29).

Conclusions In patients with ADHF, intravenous levosimendan provided rapid and durable symptomatic relief. As dosed in this trial, levosimendan was associated with an increased risk of adverse cardiovascular events. (Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure; NCT00048425)

左西孟旦是一种伴有血管扩张效应的正性肌力药物。为了评估其在短期治疗急性失代偿性心力衰竭患者中的有效性和安全性，来自德克萨斯大学西南医学中心的 Milton Packer博士等人进行了一项研究，研究结果发表于JACC 2013年4月2期卷1。作者发现静注左西孟旦可以带来快速并持久的症状缓解，但也可导致不良心血管事件发生的危险性增高。

研究者开展了两个序贯试验。第一个是在一百个病人中研发出一种新的测量药效的方法，另一个是用这个方法来评估左西孟旦在新增六百个患者中的药效。以急性失代偿性心力衰竭收住入院的病人在标准治疗以外接受了安慰剂或者静注左西孟旦二十四小时的治疗。主要的疗效指标为，在随机化分组五天后综合性评估出的患者临床状态改变。

在三个特定时间点（6小时，24小时，五天），600个病人的试验中，更多接受左西孟旦治疗的病人比接受安慰剂的病人临床状态改善（58人：44人），并且接受左西孟旦的病人更少发生病情恶化（58人：82人）（由于分组差异造成的p=0.15）。尽管安慰剂组的病人有更加频繁的强化辅助治疗，两者的疗效差异还是很明显（79人：45人）。持续应用五天左西孟旦可改善患者的自我评估状态及B型钠尿肽水平，从而使得住院时间缩短。并且在一百个患者的预试验中也存在相似的发现。然而，左西孟旦有可能增加灌注期低血压和心律失常的发生，并且在两个实验中均有数字上更高的死亡风险（90天后，接受左西孟旦的患者350人中有49人，而接受安慰剂的患者350人中有40人死亡，p=0.29）。

在急性失代偿性心力衰竭患者中，静注左西孟旦可以带来快速并持久的症状缓解。也如试验所得，左西孟旦可使得不良心血管事件发生增加。
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