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Efficacy and safety of the pulsed infusions of levosimendan in outpatients with advanced heart failure (LevoRep) study: a multicentre randomized trial.
左西孟旦脉冲输注在门诊晚期心力衰竭 (LevoRep) 患者中的疗效和安全性研究: 一项多中心随机试验。
Advanced heart failure Levosimendan Outcome Outpatient setting Pulsed infusions Safety
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摘要

AIMS:The aim of this study was to determine whether intermittent ambulatory treatment with levosimendan would improve functional capacity, quality of life, and event-free survival in patients with advanced heart failure.
METHODS AND RESULTS:This was a prospective, randomized, double-blind, placebo-controlled, multicentre, parallel-group trial of pulsed infusions of levosimendan in 120 outpatients with advanced heart failure (EF ≤35%, NYHA class III or IV). The study was conducted at 11 centres in Austria, Greece, and Germany. Levosimendan (0.2 µg/kg/min) or placebo was administered for 6 h at 2-week intervals over 6 weeks, in addition to standard care therapy. The primary outcome was the proportion of patients with a ≥20% improvement in the 6 min walk test and a ≥15% score increase on the Kansas City Cardiomyopathy Questionnaire at the end of the 24-week study period. Secondary outcomes included event-free survival after 24 weeks. Analyses were performed on an intention-to-treat basis. The primary endpoint was reached in 19% of patients receiving levosimendan and 15.8% of patients receiving placebo (odds ratio 1.25; 95% confidence interval 0.44-3.59; P = 0.810). Cardiac death (four vs. one), heart transplants (two vs. one), and acute heart failure (14 vs. nine) were more frequent with placebo as compared with levosimendan. The incidence of side effects was comparable between groups.
CONCLUSION:Intermittent ambulatory treatment with levosimendan in patients with advanced heart failure did not improve significantly functional capacity or quality of life as compared with placebo. An adequately powered, event-driven trial is warranted to enlarge on our findings.
TRIAL REGISTRATION:NCT01065194.

译文

目的: 本研究的目的是确定左西孟旦间歇非卧床治疗是否能改善晚期心力衰竭患者的功能能力、生活质量和无事件生存。
方法和结果: 这是一个前瞻性、随机、双盲、安慰剂对照、多中心、在 120 名门诊晚期心力衰竭患者 (EF ≤ 35%,NYHA III 级或 IV 级) 中进行左西孟旦脉冲输注的平行组试验。这项研究在奥地利、希腊和德国的 11 个中心进行。除了标准护理疗法外,还每隔 2 周服用左西孟旦 (0.2 μ g/kg/min) 或安慰剂 6 小时。主要结果是在 24 周研究结束时,6 分钟步行测试改善 ≥ 20%,堪萨斯城心肌病问卷评分增加 ≥ 15% 的患者比例。周期。次要结果包括 24 周后的无事件生存。分析是在意向治疗的基础上进行的。19% 接受左西孟旦的患者和 15.8% 接受安慰剂的患者达到了主要终点 (比值比 1.25; 95% 置信区间 0.44-3.59; P = 0.810)。与左西孟旦相比,安慰剂组心源性死亡 (4 例对 1 例) 、心脏移植 (2 例对 1 例) 和急性心力衰竭 (14 例对 9 例) 更为频繁。两组之间的副作用发生率具有可比性。
结论: 与安慰剂相比,在晚期心力衰竭患者中使用左西孟旦间歇行走治疗并没有显著改善功能能力或生活质量。一个充分动力的、事件驱动的试验需要扩大我们的发现。
试用注册: nct01065194。

Levosimendan

重症 心力衰竭 药物
概述  :  

左西孟旦是唯一的与肌钙蛋白C具有较高亲和力的强心药,是新一代强心药物钙增敏剂类中第一个上市品种,临床上主要用于治疗各种急性心力衰竭病症。分子式是C14H12N6O,分子量为280.28。   作用机制 1.钙离子敏感作用 左西盂旦治疗剂量不增加细胞内钙浓度和心肌耗氧量,增加心肌收缩蛋白对Ca2+的敏感性,使Ca2+诱导的心肌收缩所必需的心肌纤维蛋白的空间构型得以稳定,从而使心肌收缩力增加。左西孟旦的另一个特点是当心肌细胞内Ca2+浓

Levosimendan

释义   左西孟旦

例句   The Vasodilatory Effects of Levosimendan on the Human Internal Mammary Artery.左西孟旦对人内乳动脉的舒张作用。

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