Yusuf Salim, Pitt Bertram, Davis Clarence E, Hood William B, Cohn Jay N
N Engl J Med. 1991 Aug 1;325(5):293-302. doi: 10.1056/NEJM199108013250501.
Patients with congestive heart failure have a high mortality rate and are also hospitalized frequently. We studied the effect of an angiotensin-converting-enzyme inhibitor, enalapril, on mortality and hospitalization in patients with chronic heart failure and ejection fractions less than or equal to 0.35.
Patients receiving conventional treatment for heart failure were randomly assigned to receive either placebo (n = 1284) or enalapril (n = 1285) at doses of 2.5 to 20 mg per day in a double-bind trial. Approximately 90 percent of the patients were in New York Heart Association functional classes II and III. The follow-up averaged 41.4 months.
There were 510 deaths in the placebo group (39.7 percent), as compared with 452 in the enalapril group (35.2 percent) (reduction in risk, 16 percent; 95 percent confidence interval, 5 to 26 percent; P = 0.0036). Although reductions in mortality were observed in several categories of cardiac deaths, the largest reduction occurred among the deaths attributed to progressive heart failure (251 in the placebo group vs. 209 in the enalapril group; reduction in risk, 22 percent; 95 percent confidence interval, 6 to 35 percent). There was little apparent effect of treatment on deaths classified as due to arrhythmia without pump failure. Fewer patients died or were hospitalized for worsening heart failure (736 in the placebo group and 613 in the enalapril group; risk reduction, 26 percent; 95 percent confidence interval, 18 to 34 percent; P less than 0.0001).
The addition of enalapril to conventional therapy significantly reduced mortality and hospitalizations for heart failure in patients with chronic congestive heart failure and reduced ejection fractions.
充血性心力衰竭患者死亡率高,且经常住院。我们研究了血管紧张素转换酶抑制剂依那普利对慢性心力衰竭且射血分数小于或等于0.35的患者死亡率和住院率的影响。
在一项双盲试验中,接受心力衰竭常规治疗的患者被随机分配接受安慰剂(n = 1284)或依那普利(n = 1285),剂量为每日2.5至20毫克。约90%的患者属于纽约心脏协会心功能II级和III级。随访平均为41.4个月。
安慰剂组有510例死亡(39.7%),依那普利组有452例死亡(35.2%)(风险降低16%;95%置信区间,5%至26%;P = 0.0036)。虽然在几类心脏性死亡中观察到死亡率降低,但最大降幅出现在因进行性心力衰竭导致的死亡中(安慰剂组251例 vs. 依那普利组209例;风险降低22%;95%置信区间,6%至35%)。治疗对归类为无泵衰竭的心律失常导致的死亡几乎没有明显影响。因心力衰竭恶化而死亡或住院的患者较少(安慰剂组736例,依那普利组613例;风险降低26%;95%置信区间,从18%至34%;P < 0.0001)。
在常规治疗基础上加用依那普利可显著降低慢性充血性心力衰竭且射血分数降低患者的心力衰竭死亡率和住院率。