左西孟旦联合多巴酚丁胺治疗难治性心力衰竭

Combination of dobutamine and levosimendan in patients with severe heart failure

目的 探讨左西孟旦联合多巴酚丁胺对难治性心力衰竭的疗效及安全性。方法 采用随机、平行、阳性药物对照临床研究。104例难治性心力衰竭患者随机分为对照组和试验组（均n=52）,对照组患者给予多巴胺2～5μg·kg-1·min-1静脉持续泵入;试验组患者给予左西孟旦初始负荷量为12μg·kg-1,注射10 min,随即以0.1μg·kg-1·min-1静脉持续泵入,两组均合用多巴酚丁胺2～4μg·kg-1·min-1静脉泵入,根据患者血压水平和反应调整相应剂量,维持24 h。比较两组患者治疗前后的呼吸困难、全身临床状况、心功能等级（NYHA分级）、左室射血分数（LVEF）、每搏输出量（SV）等改善情况和安全性。结果治疗24 h后,试验组患者呼吸困难、全身临床状况和NYHA心功能分级改善均较对照组显著（P〈0.05）。与治疗前相比,试验组患者的LVEF和SV均显著升高（P〈0.05）,而对照组无显著改变（P〉0.05）,两组比较有显著差异（P〈0.05）。对照组发生两例严重不良事件,试验组无严重不良事件发生,两组不良反应及不良事件发生率无显著差异（P〉0.05）。结论 左西孟旦联合多巴酚丁胺治疗难治性心力衰竭能显著改善患者心功能和呼吸困难等临床症状,耐受性和安全性良好。

AIM To compare the efficacy and safety of the combination of dobutamine and levosimendan in patients with refractory heart failure. METHODS A total of 104 refractory heart failure patients were recruited in this randomized, positive- controlled and parallel- group study and randomly divided into control group and experimental group （52 patients in each group）, which were treated with dopamine 2 - 5μg·kg-1·min-1 by intravenous continuous infusion or received levosimenda 12 μg·kg-1 （loading dose） for 10 minutes and then 0.1 μg·kg-1·min-1 by intravenous infusion. Both groups combined with dobutamin 2 - 4 μg·kg-1·min-1 by intravenous continuous infusion for 24 hours. And the doses were adjusted according to the blood pressure levels and response of patients. Dyspnea, general conditions, heart function （NYHA） , left ventricular ejection fraction （LVEF） , stroke volume （SV） and safety were compared before and after the treatment. RESULTS After the treatment, the clinical syndrome of dyspnea, general conditions and the classification of NYHA were improved more significant in the experiment group than the control group （P 〈 0.05）. Compared with baseline level, LVEF and SV were significantly higher in the experiment group （P 〈 0.05） , whereas no significant change in the control group （P 〉 0.05）. And there was a significant difference between the two groups （P 〈 0.05 ）. There were two serious adverse events in the control group, while no serious adverse events in the experiment group, but no significant difference in the two groups （P 〉 0.05）. CONCLUSION Compared with the conventional medications, levosimendan combination with dobutamine could improve cardiac function and symptom of patients with refractory heart failure and have similar safety.