螺内酯治疗急性心肌梗死并发慢性心力衰竭的疗效观察

The efficacy and safety of spironolactone in the treatment of chronic heart failure after acute myocardial infarction

目的 :评价螺内酯治疗急性心肌梗死并发慢性心力衰竭的有效性和安全性。方法 :在常规治疗慢性心力衰竭的基础上 ,随机分成两组 :治疗组 4 3例 ,加用螺内酯 2 0mgqd ;对照组 4 2例 ,加用安慰剂。平均随访时间 1年。主要观察终点是总死亡率、心血管病死亡率、再次入院率。结果 :螺内酯治疗组死亡 1例 (2 .3% ) ,4例需再次入院 (9.3% ) ;对照组死亡 7例 (1 6 .7% ) ,1 1例需再次入院 (2 6 .2 % )。治疗组 1例 (2 .3% )和对照组 6例 (1 4 .3% )分别因心源性原因死亡。两组总死亡率、心血管病死亡率、再次入院率相比均有显著性差别 (p <0 .0 5 )。治疗组 1例 (3.7% )有男性乳房增生症 ,两组无 1例发生高钾血症。结论 :在常规治疗基础上 ,加用螺内酯治疗急性心肌梗死并发慢性心力衰竭有效且安全。

Objective: To evaluate the efficacy and safety of spironolactone among patients with acute myocardial infarction complicated with heart failure. Method: All patients with symptomatic left ventricular dysfunction were routinely managed with a combination of 4 types of drugs: a diuretic, an ACE inhibitor, beta-blocker and (usually) digitalis. 85 patients were randomly assigned to two groups: 43 patients in spironolactone group and 42 patients as control. Spironolactone was orally given 20mg once daily. The primary end points were death from any cause and death from cardiovascular causes or hospitalization for worsening heart failure. Result: During a mean follow-up of 12 months, there were 1 death in the spironolactone group and 7 deaths in the placebo group (2.3% vs 16.7%, p<0.05). Of these deaths, 1 in the spironolactone group and 6 in the placebo group were attributed to cardiovascular causes (2.3% vs 14.3%, p<0.05). The frequency of hospitalization for worsening heart failure was significantly lower in the spironolactone group than in the placebo group(9.3% vs 26.2%, p<0.05). Gynecomastia was reported in 1 patient who was treated with spironolactone. No hyperkalemia occurred in both groups of patients. Conclusion: The addition of spironolactone to optimal medical therapy is effective and safe among patients with acute myocardial infarction complicated with heart failure.