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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 injection in patients with severe aortic stenosis and heart failure, and to analyze the improvement of cardiac function and symptoms before and after treatment to guide the clinical treatment. METHODS: Twenty patients admitted to our hospital from January 2014 to December 2015 were enrolled in this study. Echocardiography was confirmed as severe aortic stenosis, left ventricular ejection fraction (LVEF) ≤45% and New York Heart Association (NYHA) Cardiac function grade Ⅲ ~ Ⅳ level, with conventional anti-heart failure treatment ineffective patients. Specific test method: given levosimendan injection 0.1μg / (kg · min) continuous intravenous infusion of 24 h before and after treatment were measured echocardiography, recording before and after treatment LVEF, degree of dyspnea, cardiac function classification and plasma N-terminal B-type natriuretic peptide (NT-proBNP) levels. Compare the improvement of cardiac function and clinical symptoms before and after treatment. Results: After treatment, the patients’ heart function grading was better than before treatment (P = 0.025). The NT-proBNP level was significantly decreased after treatment (9101.6 ± 7368.0 pg / ml vs 13776.5 ± 9503.7 pg / ml, P = 0.018 ], Compared with before treatment differences were statistically significant. LVEF [(31.1 ± 7.5)% vs (33.1 ± 8.5)%, P = 0.078] and mean heart rate [(79.6 ± 13.8) / min vs (82.8 ± 9.5) times / min, P=0.200 before and after treatment) Systolic blood pressure [(99.6 ± 11.7) mm Hg (1 mmHg = 0.133 kPa vs 97.2 ± 12.1 mmHg, P = 0.071] showed no significant difference. 24 h after treatment, patients with dyspnea were significantly improved and improved accounted for 40% (8/20), 50% (10/20). Conclusion: Preliminary exploratory studies confirm that levosimendan injection can improve cardiac function in patients with severe aortic stenosis and heart failure, alleviate the symptoms of dyspnea and reduce the level of NT-proBNP, with a certain safety and tolerability.