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伊伐布雷定治疗射血分数保留型心力衰竭的临床疗效:一项随机、双盲、对照临床研究 被引量:11

Clinical Effect of Ivabradine in the Treatment of Heart Failure with Preserved Ejection Fraction:a Randomized,Double Blind,Controlled Clinical Study
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摘要 背景近年心力衰竭(HF)发病率呈直线上升趋势,其中射血分数保留型心力衰竭(HFpEF)患者约占50%,且病死率高、预后差。临床常采用伊伐布雷定治疗射血分数降低的心力衰竭(HFrEF),而伊伐布雷定是否可使HFpEF患者获益目前尚不完全明确。目的采用随机、双盲、对照的临床试验探讨伊伐布雷定治疗HFpEF的临床疗效,以为HFpEF的临床治疗提供新证据。方法选取2017年8月—2018年8月保定市第四中心医院心内科收治的HFpEF患者122例,采用随机数字表法分为治疗组61例和对照组61例,且研究者和患者对分组情况均不知情。患者入院后均接受常规内科药物治疗,治疗组患者口服伊伐布雷定,对照组患者口服安慰剂治疗,两组患者均持续治疗8个月。比较两组患者治疗前后6 min步行距离(6MWD)、血浆N末端脑钠肽前体(NT-proBNP)水平、左房室瓣血流持续时间、左心室舒张末期容积指数(LVEDVI)、每搏输出量、左心房容积指数(LAVI)、动脉弹性与心室收缩末期弹性比值(Ea/Ees)及心率(HR),记录两组患者治疗期间不良反应发生情况。结果两组患者治疗前6MWD、血浆NT-proBNP水平、左房室瓣血流持续时间、LVEDVI、每搏输出量、LAVI、Ea/Ees、HR及治疗后每搏输出量比较,差异无统计学意义(P>0.05);治疗组患者治疗后6MWD、左房室瓣血流持续时间长于对照组,血浆NTproBNP水平及LAVI、Ea/Ees、HR低于对照组,LVEDVI高于对照组(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论伊伐布雷定可有效改善HFpEF患者HR及心功能,且安全性高。 Background Prevalence of heart failure(HF)has shown a straight upward trend in recent years.Heart failure with preserved ejection fraction(HFpEF)accounts for about 50%of all patients with HF,with high mortality and poor prognosis.Ivabradine is often used clinically to treat heart failure with reduced ejection fraction(HFrEF),but whether ivabradine can benefit HFpEF patients is still not completely clear.Objective To investigate the clinical effect of ivabradine in the treatment of HFpEF by a randomized,double blind,controlled clinical study,in order to provide a new basis for clinical treatment.Methods From August 2017 to August 2018,122 patients with HFpEF admitted to Department of Cardiology,Baoding Fourth Central Hospital were selected,and they were divided into treatment group and control group according to random number table method,61 cases in each group,and neither the researchers nor the patients knew about the grouping.Patients received conventional medical drug therapy after admission,and patients in treatment group were given ivabradine orally,patients in control group were given placebo,both groups were treated for 8 months.6 min walking distance(6MWD),plasma NT-proBNP level,duration of left atrioventricular valve blood flow,LVEDVI,stroke volume,LAVI,Ea/Ees and HR before and after treatment were compared between the two groups,the incidence of adverse reactions of the two groups were recorded.Results No significant difference of 6MWD,plasma NT-proBNP level,duration of left atrioventricular valve blood flow,LVEDVI,stroke volume,LAVI,Ea/Ees and HR before treatment and stroke volume after treatment was found between the two groups(P>0.05);after treatment,6MWD,duration of left atrioventricular valve blood flow in treatment group were longer than those in control group,plasma NT-proBNP level and LAVI,Ea/Ees,HR in treatment group were lower than those in control group,LVEDVI in treatment group was higher than that in control group(P<0.05).There was no significant difference in the incidence of adverse between the two groups(P>0.05).Conclusion Ivabradine can effectively improve HR and cardiac function of HFpEF patients,and has a high safety.
作者 刘媛媛 张宏波 LIU Yuanyuan;ZHANG Hongbo(Department of Cardiology,Baoding Fourth Central Hospital,Baoding 072350,China)
出处 《实用心脑肺血管病杂志》 2020年第9期16-20,共5页 Practical Journal of Cardiac Cerebral Pneumal and Vascular Disease
关键词 心力衰竭 射血分数保留 伊伐布雷定 心率 治疗结果 随机对照试验 双盲研究 Heart failure Heart failure with preserved ejection fraction Ivabradine Heart rate Treatment outcome Randomized controlled trial Double-masked study
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