Objective To explore the efficacy and safety of urapidil combined with dopamine and compared with milrinone alone in treating refractory heart failure on more extended usage occasions. Methods This is a randomized,open,non-placebo-controlled, non-long-term follow-up and no endpoint of prognosis clinical analysis to test the efficacy and safety of drugs. A total of 247 patients diagnosed as refractory heart failure were enrolled in this study. The patients were randomly allocated into two groups (151 cases in the urapidil combined with dopamine group,96 cases in milrinone group). Results Compared to data baseline,the two groups show significant improvement after treatment indicated by echocardiography (P<0.01) ;plasma NT—proBNP decreased significantly (P<0.05);systemic symptoms markedly improved,the improvement rates were 85.14% ,87.91% respectively;dyspnea improved and urine output of 24 hours increased significantly in both groups (P<0.01),Those improvement above did not show difference between the two groups (P>0.05). In respect to treatment safety,comparing the combination group to the milrinone group, the rate of hypotension were 5.96%, 12.5% respectively,the rate of ventricular arrhythmias were 3.97%,4.17% respectively,the rate of nausea and vomiting,and headache were 3.31%,2.20%(P<0.05)respectively. The rate of acute myocardial infarction were 1.99%, 2.20% (P>0.05) respectively. Two cases of cerebral infarction occurred in the milrinone group. Heart rate decreased in the combination group after treatment,however,heart rate increased in the milrinone group. After the milrinone administration,systolic blood pressure dropped more significantly than the combination group (P<0.01). Conclusions Both the combined urapidil with dopamine and milrinone alone is safe and effective in treatment of refractory heart failure,the combination group is safer and cost less.%目的 观察和比较乌拉地尔加多巴胺与米力农在较广泛使用条件下治疗顽固性心力衰竭的疗效及安全性.方法 入选247例顽固性心力衰竭患者,随机分为两组:联合组151例,米力农组96例.采用随机、开放、无安慰药对照、无长期随访和预后终点的方法采集和统计信息,进行临床疗效分析和安全性评价.结果 与基线相比,两组患者治疗后心脏超声指标均显著改善(P＜0.01),血浆N末端B型利钠肽(NT-proBNP)显著下降(P＜0.05).治疗后全身症状明显好转(P＜0.01),联合组与米力农组好转率分别为85.14％、87.91％;两组明显改善呼吸困难及增加24 h尿量(P＜0.01).上述指标治疗后两组比较均无差异(P＞0.05).安全性方面两组比较,联合组与米力农组低血压发生率分别为5.96％、12.5％(P＜0.05),室性心律失常分别为3.97％、4.17％(P＜0.05),恶心、呕吐及头痛分别为3.31％及2.20％ (P＜0.05),急性心肌梗死发生率分别为1.99％、2.20％(P＞0.05),米力农组发生2例脑梗死.联合组治疗后心率下降(P＜0.01),米力农组治疗后心率增加(P＜0.05).米力农组治疗后收缩压下降较联合组明显(P＜0.01).结论 乌拉地尔加多巴胺与米力农短期治疗顽固性心力衰竭效果良好,其好转率相当,安全性良好.联合组不良反应事件发生率低,用药物费用较少.
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