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伊伐布雷定治疗不适当窦性心动过速患者的临床疗效:前瞻性、随机、安慰剂对照、双盲、交叉评估。

Clinical efficacy of ivabradine in patients with inappropriate sinus tachycardia: a prospective, randomized, placebo-controlled, double-blind, crossover evaluation.

机构信息

Arrhythmias and Electrophysiology Center, I.R.C.C.S. Policlinico San Donato, Milan, Italy.

出版信息

J Am Coll Cardiol. 2012 Oct 9;60(15):1323-9. doi: 10.1016/j.jacc.2012.06.031. Epub 2012 Sep 12.

DOI:10.1016/j.jacc.2012.06.031
PMID:22981555
Abstract

OBJECTIVES

The purpose of this study was to investigate the role of ivabradine in the treatment of symptomatic inappropriate sinus tachycardia using a double-blind, placebo-controlled, crossover design.

BACKGROUND

Due to its I(f) blocking properties, ivabradine can selectively attenuate the high discharge rate from sinus node cells, causing inappropriate sinus tachycardia.

METHODS

Twenty-one patients were randomized to receive placebo (n=10) or ivabradine 5 mg twice daily (n=11) for 6 weeks. After a washout period, patients crossed over for an additional 6 weeks. Each patient underwent symptom evaluation and heart rate assessment at the start and finish of each phase.

RESULTS

After taking ivabradine, patients reported elimination of >70% of symptoms (relative risk: 0.25; 95% CI: 0.18 to 0.34; p<0.001), with 47% of them experiencing complete elimination. These effects were associated with a significant reduction of heart rate at rest (from 88±11 beats/min to 76±11 beats/min, p=0.011), on standing (from 108±12 beats/min to 92±11 beats/min, p<0.0001), during 24 h (from 88±5 beats/min to 77±9 beats/min, p=0.001), and during effort (from 176±17 beats/min to 158±16 beats/min, p=0.001). Ivabradine administration was also associated with a significant increase in exercise performance. No cardiovascular side effects were observed in any patients while taking ivabradine.

CONCLUSIONS

In this cohort, ivabradine significantly improved symptoms associated with inappropriate sinus tachycardia and completely eliminated them in approximately half of the patients. These findings suggest that ivabradine may be an important agent for improving symptoms in patients with inappropriate sinus tachycardia.

摘要

目的

本研究旨在采用双盲、安慰剂对照、交叉设计,探讨伊伐布雷定治疗有症状的不适当窦性心动过速的作用。

背景

由于其 I(f)阻断特性,伊伐布雷定可选择性减弱窦房结细胞的高放电率,从而导致不适当窦性心动过速。

方法

21 例患者随机分为安慰剂组(n=10)或伊伐布雷定 5mg,每日两次(n=11),疗程 6 周。洗脱期后,患者交叉治疗 6 周。每位患者在每个阶段开始和结束时进行症状评估和心率评估。

结果

服用伊伐布雷定后,患者报告 >70%的症状消除(相对风险:0.25;95%CI:0.18 至 0.34;p<0.001),其中 47%的患者症状完全消除。这些效果与静息心率(从 88±11 次/分降至 76±11 次/分,p=0.011)、站立位心率(从 108±12 次/分降至 92±11 次/分,p<0.0001)、24 小时心率(从 88±5 次/分降至 77±9 次/分,p=0.001)和运动时心率(从 176±17 次/分降至 158±16 次/分,p=0.001)的显著降低相关。伊伐布雷定治疗还与运动表现的显著改善相关。在服用伊伐布雷定时,没有观察到任何患者出现心血管副作用。

结论

在本队列中,伊伐布雷定显著改善了不适当窦性心动过速相关症状,并使约一半的患者完全消除了这些症状。这些发现表明,伊伐布雷定可能是改善不适当窦性心动过速患者症状的重要药物。

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