左西孟旦注射液应用于重度主动脉瓣狭窄合并心力衰竭患者的初步研究

Preliminary Study of Levosimendan on Patients With Severe Aortic Stenosis and Heart Failure

目的:探索左西孟旦注射液应用于重度主动脉瓣狭窄合并心力衰竭患者的安全性和疗效,分析用药前后心功能和症状改善情况,从而指导临床治疗。方法:选择2014-01至2015-12入住我院的20例患者,入选标准:超声心动图证实为重度主动脉瓣狭窄、左心室射血分数(LVEF)≤45%且纽约心脏协会(NYHA)心功能分级Ⅲ~Ⅳ级、用常规抗心力衰竭治疗效果不佳的患者。具体试验方法:给予左西孟旦注射液0.1μg/(kg·min)持续静脉泵入24 h,在用药前后分别进行超声心动图检测,记录用药前后LVEF、呼吸困难程度、心功能分级及血浆N末端B型利钠肽原(NT-proBNP)水平。对比用药前后心功能和临床症状的改善情况。结果:用药后患者心功能分级较用药前好转(P=0.025),NT-proBNP水平在用药后有明显下降[(9101.6±7368.0)pg/ml vs(13776.5±9503.7)pg/ml,P=0.018],较用药前差异均有统计学意义。患者用药前后LVEF[(31.1±7.5)%vs(33.1±8.5)%,P=0.078]、平均心率[(79.6±13.8)次/min vs(82.8±9.5)次/min,P=0.200]、收缩压[(99.6±11.7)mm Hg(1 mmHg=0.133 kPa)vs(97.2±12.1)mmHg,P=0.071]差异无统计学意义。用药后24 h患者呼吸困难明显好转者和好转者分别占40%(8/20)、50%(10/20)。结论:初步探索性研究证实左西孟旦注射液可改善重度主动脉瓣狭窄伴心力衰竭患者的心功能分级,缓解呼吸困难症状,降低NT-proBNP水平,具有一定的安全性和耐受性。

Objective： To explore the safety and efficacy of levosimendan in treating the patients with severe aortic stenosis and to analyze the cardial function before and after medication in order to guide clinical treatment. Methods： A total of 20 patients admitted in our hospital from 2014-01 to 2015-12 were enrolled with the standard of echocardiography confirmed severe aortic stenosis, left ventricular ejection fraction （LVEF）〈45%, NYHA Ⅲ-Ⅳ and inefficacy for conventional anti-heart failure drug therapy. The patients received intravenous infusion of levosimendan at 0.11.tg/（kg·min） by persistent pumping for 24 hours. Echocardiography, LVEF, dyspnea condition, NYHA grading and plasma levels of NT-proBNP were recorded pre- and post-medication to compare the cardiac function and symptoms of levosimendan therapy. Results： After levosimendan treatment, NYHA grade was improved, P=0.025 and NT-proBNP was reduced （9101.6±7368.0） pg/mLvs （13776.5±9503.7） pg/mL, P=0.018. The following parameters were similar before and after levosimendan therapy： LVEF （31.1±7.5）% vs （33.1±8.5）%, P=-0.078, the average heart rate （79.6±13.8） bmp vs （82.8±9.5） bmp, P=0.200 and systolic blood pressure （99.6±11.7） mmHg vs （97.2±12.1） mmHg, P=0.071. There were 40% （8/20） patients with obviously improved and 50% （10/20） with improved dyspnea symptoms after levosimendan treatment. Conclusion： Our preliminary study presented that levosimendan could improve NYHA grading, remit dyspnea symptom and reduce blood NT-proBNP level in patients with severe aortic stenosis and heart failure; it had safety and tolerability at certain degree in clinical practice.