卡维地洛治疗慢性心力衰竭的临床研究

Carvedilol in chronic heart failure: a single-blind, randomized, placebo-controlled trial

目的 评价卡维地洛治疗慢性心力衰竭 (心衰 )的疗效和安全性。方法 在此多中心、随机安慰剂对照的临床研究中 ,以慢性轻、中度心衰患者为研究对象 ,在心衰标准用药的基础上 ,卡维地洛由小剂量开始 ,逐渐递增至目标剂量。在 7个月的疗程中 ,检查超声心动图 3次 ,以评价左室功能和容积。结果 7家医疗中心共入选卡维地洛组 65例以及安慰剂组 31例。在试验结束 ,两组的左室射血分数 (LVEF)均有增加 ,卡维地洛组由 (2 7 9± 6 2 ) %增至 (35 2± 9 0 ) % ,安慰剂组由 (2 8 7±5 9) %增至 (32 2± 7 4) % ;但卡维地洛组LVEF的增加值显著高于安慰剂组 ,分别为 (7 5± 7 8) %和(3 0± 5 3) % ,P =0 0 0 4 1。经 7个月的治疗 ,卡维地洛组显著缩小左室舒张末期容积 (EDV)和收缩末期容积 (ESV) ,分别为 (- 1 8 3± 35 8)ml、P =0 0 0 0 3和 (- 2 6 8± 34 5)ml、P =0 0 0 0 1。而安慰剂组在试验终点 ,左室EDV和ESV均有增加 ,分别增加 (7 5± 33 0 )ml和 (2 9± 30 0 )ml。卡维地洛组有 40例 (61 5 % )耐受目标剂量 (50～ 1 0 0mg/d) ,其多见的不良反应为头晕 ,但不良反应发生率与安慰剂比较差异无显著性 ,两组均未发现肝、肾功能损害或血象、电解质和糖代谢变化。本研究中 3例死亡 ,均在安慰剂组。安慰?

Objective To evaluate the efficacy and safety of carvedilol on chronic heart failure Methods In this multicenter, single blind, randomized, placebo controlled study, carvedilol or placebo were titrated from low dose to target dose in addition to standard therapy for patients with mild and moderate chronic heart failure All patients were examined with echocardiography three times during a seven month period,assessing LV function and volume Results A total of 96 patients from 7 medical centers entered the study ,among whom 65 were assigned to carvedilol group and 31 to placebo group LV ejection fraction(LVEF) increased in both groups by(27 9±6 2)% to (35 2±9 0)% in carvedilol group and (28 7±5 9)% to (32 2±7 4)% in placebo group at the end of the study, with the range of LVEF increasing more significantly in carvedilol group [(7 5±7 8)% than in placebo group (3 0±5 3)%, P =0 004 1] After seven month therapy decreases in both LV end distolic volume (EDV) (-18 3±35 8)ml ( P =0 000 3) and LV end systolic volume (ESV) (-26 8±34 5)ml ( P =0 000 1) were found in carvedilol group, whereas both EDV (7 5±33 0)ml and ESV (2 9±30 0)ml increased at the end of the study in placebo group Forty patients(61 5%) were tolerant with carvedilol target dose (25-50 mg, bid) There was no significant difference of adverse reaction between the two groups. No significant changes of liver, renal function, blood routine test, electrolyte and blood sugar were found in both groups The side effect of dizziness was relatively more often in carvedilol group Three patients were dead in placebo group and the mortality in placebo group was significantly increased ( P =0 032). Conclusion This study demonstrates that carvedilol has antiremodeling effects on the LV in patients with mild and moderate chronic heart failure and carvedilol is a quite safe β blocking agent