比索洛尔治疗慢性心力衰竭的临床疗效观察

Effect of Bisoprolol on Chronic Heart Failure

目的研究比索洛尔(bisoprolol)治疗慢性心力衰竭的临床疗效及安全性。方法采用多中心、随机、开放、平行对照临床试验,以卡维地洛为对照药。128例慢性心力衰竭患者[心室功能分级(NYHA分级Ⅱ-Ⅳ级,经超声心动图证实射血分数≤0.4,并接受了至少14 d以上的心力衰竭常规治疗]。若未服用过受体阻滞药患者随机分配到比索洛尔或卡维地洛组,如正在使用β受体阻滞药患者逐渐减量至停药(停药至少14 d)。治疗期分为初试期、剂量递增期和剂量维持期,疗程6月。每次随访测血压、心率,评估心功能,记录不良事件。结果治疗后两组左室射血分数较治疗前明显改善,比索洛尔组(n=63)提高11%,卡维地洛组(n=65)提高10%,两组治疗后左室射血分数改善程度组内比较均有统计学意义,P<0.01。两组治疗后心衰症状均较治疗前改善,NYHA分级比索洛尔组和卡维地洛组治疗前心功能Ⅲ级分别为21(33.3%)例和26(40.0%)例,治疗后减少至分别为6例(9.5%)和7例(10.8%),两组治疗前后组内比较有统计学意义,P<0.01。不良事件发生率:比索洛尔组和卡维地洛组分别为38%和46%,组间比较无统计学意义。结论慢性心力衰竭患者应用比索洛尔和卡维地洛一样安全有效,比索洛尔可以达到与卡维地洛靶剂量长期治疗相同的疗效。

OBJECTIVE To observe the effect and safety of bisoprolol on chronic heart failure（CHF）. METHODS The multicenter,randomized,open,parallel control clinical trial clinical trial was conducted. 128 CHF patients （NYHA Ⅱ to Ⅳ, LVEF≤0. 4, on routine therapy at least 14 d） were involved in the study. The patients without β-blocker were designed randomly into 2 groups with the treatment of bisoprolol and carvedilol, respectivley ; In patients treated withβ-blocker,β-blocker was reduced gradually till drug with- drawal. The study lasted 6 months including preliminary period, dose increasing period and dose maintaining period. Blood pressure, heart rate and heart function were evaluated for each follow-up and adverse events were recorded. RESULTS The LVEF was improved significantly after treatment, （11% for bisoprolol group, and 10% for carvedilol group,P 〈0. 01 ）. The symptoms of chronic heart failure in both groups were improved, the cases of grade Ⅲ （ NYHA class） were reduced from 33.3% to 9. 5% in bisoprolol group, from 40. 0% to 10. 8% in carvedilol group, which showed statistical differences between before and after treatment（P 〈 0. 01 ）. No significant difference was found on adverse events between bisolorol group （38%） and carvedilol group （46%） o CONCLUSION Bisoprolol is as safe and effective as carvedilolin after the long-term use for the chronic heart failuretreatment.