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急性心力衰竭患者使用伊伐布雷定超说明书用药的安全性和有效性

Safety and efficacy of off-label use of ivabradine in patients with acute heart failure.

作者信息

Othman Khaled M Said, Mostafa Mohamed Ahmed Radwan, Yosef Ahmed Elsayed, Abdeltawab Adham Ahmed

机构信息

Department of Cardiology, Faculty of Medicine, Ain Shams University, Cairo EgyptEgypt.

出版信息

J Saudi Heart Assoc. 2019 Oct;31(4):179-187. doi: 10.1016/j.jsha.2019.05.006. Epub 2019 Jun 12.

Abstract

BACKGROUND

Ivabradine is approved to improve exercise tolerance and quality of life in patients with chronic heart failure; its use in acute heart failure (AHF) has not previously been studied.

METHODS

Forty adult patients admitted with AHF were randomized into two groups; Group 1 patients were prescribed beta-blockers (BBs) and Group 2 patients were prescribed ivabradine. Both groups were given optimum anti-failure treatment for AHF. All patients were assessed for heart rate (HR), 6-minute walk test (6MWT), New York Heart Association (NYHA) classification, and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) before and after 1 month of therapy.

RESULTS

BBs or ivabradine among optimum medical therapy for AHF resulted in a significant improvement in all the studied parameters (NYHA class; 6MWT distance; HR and Borg scale dyspnea/fatigue score before and after the walk). The MLWHFQ was significantly worse during the follow-up in both groups. At the end of follow-up, there was a comparable beneficial effect attributed to the significant HR reduction observed in both groups.

CONCLUSION

The results of this pilot study demonstrated the safety of the early use of ivabradine alone versus BBs when tolerated in patients admitted with AHF (both acutely decompensated as well as ). Both groups achieved comparable reduction in HR with improvement in functional capacity and exercise tolerance.

摘要

背景

伊伐布雷定已被批准用于改善慢性心力衰竭患者的运动耐量和生活质量;此前尚未对其在急性心力衰竭(AHF)中的应用进行研究。

方法

40例成年AHF患者被随机分为两组;第1组患者服用β受体阻滞剂(BBs),第2组患者服用伊伐布雷定。两组均给予AHF的最佳抗心力衰竭治疗。在治疗1个月前后,对所有患者进行心率(HR)、6分钟步行试验(6MWT)、纽约心脏协会(NYHA)分级以及明尼苏达心力衰竭生活问卷(MLWHFQ)评估。

结果

在AHF的最佳药物治疗中,BBs或伊伐布雷定使所有研究参数(NYHA分级;6MWT距离;步行前后的HR和Borg量表呼吸困难/疲劳评分)均有显著改善。两组随访期间MLWHFQ均显著变差。随访结束时,两组因HR显著降低而产生了相当的有益效果。

结论

这项初步研究的结果表明,在AHF患者(包括急性失代偿患者)中,当耐受时,早期单独使用伊伐布雷定与BBs相比是安全的。两组在心率降低方面相当,同时功能能力和运动耐量均有所改善。

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