Lancet. 1997 Feb 8;349(9049):375-80.
In patients with heart failure, beta-blocker therapy improves left-ventricular function after 3-6 months of treatment, but effects of such treatment on symptoms and exercise performance are inconsistent, and the longer-term effects on death and other serious clinical events remain uncertain. We have investigated these issues in a double-blind, placebo-controlled, randomised trial of the beta-adrenergic blocker carvedilol (which also has alpha 1-blocking properties).
415 patients with chronic stable heart failure were randomly assigned treatment with carvedilol (207) or matching placebo (208). At baseline, 6 months, and 12 months, we measured left-ventricular ejection fraction, left-ventricular dimensions, treadmill exercise duration, 6 min walk distance, New York Heart Association (NYHA) class, and specific activity scale (SAS) score. Double-blind follow-up continued for an average of 19 months, during which all deaths, hospital admissions, and episodes of worsening heart failure were documented.
After 12 months, left-ventricular ejection fraction had increased by 5.3% (2p < 0.0001) and end-diastolic and end-systolic dimensions had decreased by 1.7 mm (2p = 0.06) and 3.2 mm (2p = 0.001), respectively, in the carvedilol group compared with the placebo group. During the same period that were no clear changes in treadmill exercise duration, 6 min walk distance, NYHA class, or SAS score. After 19 months, the frequency of episodes of worsening heart failure was similar in the carvedilol and placebo groups (82 vs 75; relative risk 1.12 [95% Cl 0.82-1.53]) but the rate of death or hospital admission was lower in the carvedilol group than in the placebo group (104 vs 131; relative risk 0.74 [0.57-0.95]).
The beneficial effects of carvedilol on left-ventricular function and size were maintained for at least a year after the start of treatment, but carvedilol had no effect on exercise performance, symptoms, or episodes of worsening heart failure. There was an overall reduction in events resulting in death or hospital admission, and a year of treatment with carvedilol resulted in the avoidance of one such serious event among every 12-13 (SE 5) of these patients with chronic stable heart failure.
在心力衰竭患者中，β受体阻滞剂治疗3 - 6个月后可改善左心室功能，但该治疗对症状和运动能力的影响并不一致，其对死亡和其他严重临床事件的长期影响仍不确定。我们在一项关于β肾上腺素能阻滞剂卡维地洛（它也具有α1受体阻滞特性）的双盲、安慰剂对照、随机试验中研究了这些问题。
415例慢性稳定心力衰竭患者被随机分配接受卡维地洛治疗（207例）或匹配的安慰剂治疗（208例）。在基线、6个月和12个月时，我们测量了左心室射血分数、左心室尺寸、跑步机运动持续时间、6分钟步行距离、纽约心脏协会（NYHA）心功能分级和特定活动量表（SAS）评分。双盲随访平均持续19个月，在此期间记录了所有死亡、住院和心力衰竭恶化发作情况。
12个月后，与安慰剂组相比，卡维地洛组的左心室射血分数增加了5.3%（P < 0.0001），舒张末期和收缩末期尺寸分别减小了1.7毫米（P = 0.06）和3.2毫米（P = 0.001）。在同一时期，跑步机运动持续时间、6分钟步行距离、NYHA心功能分级或SAS评分没有明显变化。19个月后，卡维地洛组和安慰剂组心力衰竭恶化发作的频率相似（82次对75次；相对危险度1.12 [95%可信区间0.82 - 1.53]），但卡维地洛组的死亡或住院率低于安慰剂组（104次对131次；相对危险度0.74 [0.57 - 0.95]）。
卡维地洛对左心室功能和大小的有益作用在治疗开始后至少维持了一年，但卡维地洛对运动能力、症状或心力衰竭恶化发作没有影响。导致死亡或住院的事件总体有所减少，在这些慢性稳定心力衰竭患者中，使用卡维地洛治疗一年可使每12 - 13（标准误5）例患者避免发生一次此类严重事件。
