Waagstein F, Bristow M R, Swedberg K, Camerini F, Fowler M B, Silver M A, Gilbert E M, Johnson M R, Goss F G, Hjalmarson A
Division of Cardiology, Sahlgren's Hospital, Göteborg, Sweden.
Lancet. 1993 Dec 11;342(8885):1441-6. doi: 10.1016/0140-6736(93)92930-r.
Several small studies have suggested beneficial effects of long-term beta-blocker treatment in idiopathic dilated cardiomyopathy. Our large multicentre study aimed to find out whether metoprolol improves overall survival and morbidity in this disorder. 383 subjects with heart failure from idiopathic dilated cardiomyopathy (ejection fraction < 0.40) were randomly assigned placebo or metoprolol. 94% were in New York Heart Association functional classes II and III, and 80% were receiving background treatment. A test dose of metoprolol (5 mg twice daily) was given for 2-7 days; those tolerating this dose (96%) entered randomisation. Study medication was increased slowly from 10 mg to 100-150 mg daily. There were 34% (95% CI -6 to 62%, p = 0.058) fewer primary endpoints in the metoprolol than the placebo group; 2 and 19 patients, respectively, deteriorated to the point of needing transplantation and 23 and 19 died. The change in ejection fraction from baseline to 12 months was significantly greater with metoprolol than with placebo (0.13 vs 0.06, p < 0.0001). Pulmonary capillary wedge pressure decreased more from baseline to 12 months with metoprolol than with placebo (5 vs 2 mm Hg, p = 0.06). Exercise time at 12 months was significantly greater (p = 0.046) in metoprolol-treated than in placebo-treated patients. In patients with idiopathic dilated cardiomyopathy, treatment with metoprolol prevented clinical deterioration, improved symptoms and cardiac function, and was well tolerated.
几项小型研究表明,长期使用β受体阻滞剂治疗特发性扩张型心肌病具有有益效果。我们的大型多中心研究旨在查明美托洛尔是否能改善这种疾病的总体生存率和发病率。383名患有特发性扩张型心肌病(射血分数<0.40)的心力衰竭患者被随机分配接受安慰剂或美托洛尔治疗。94%的患者属于纽约心脏协会心功能II级和III级,80%的患者正在接受背景治疗。给予美托洛尔试验剂量(每日两次,每次5毫克),持续2 - 7天;能耐受该剂量的患者(96%)进入随机分组。研究药物从每日10毫克开始缓慢增加至100 - 150毫克。与安慰剂组相比,美托洛尔组的主要终点事件减少了34%(95%置信区间为 - 6%至62%,p = 0.058);分别有2名和19名患者病情恶化至需要进行移植,23名和19名患者死亡。与安慰剂相比,美托洛尔组从基线到12个月时射血分数的变化显著更大(0.13对0.06,p < 0.0001)。从基线到12个月,美托洛尔组的肺毛细血管楔压下降幅度比安慰剂组更大(5对2毫米汞柱,p = 0.06)。美托洛尔治疗组患者在12个月时的运动时间显著长于安慰剂治疗组患者(p = 0.046)。在特发性扩张型心肌病患者中,美托洛尔治疗可预防临床病情恶化,改善症状和心脏功能,且耐受性良好。