血管紧张素转换酶抑制剂佐芬普利对前壁心肌梗死后死亡率和发病率的影响。心肌梗死长期评估生存（SMILE）研究组。

The effect of the angiotensin-converting-enzyme inhibitor zofenopril on mortality and morbidity after anterior myocardial infarction. The Survival of Myocardial Infarction Long-Term Evaluation (SMILE) Study Investigators.

作者信息

Ambrosioni E, Borghi C, Magnani B

机构信息

Department of Internal Medicine, University of Bologna, Italy.

出版信息

N Engl J Med. 1995 Jan 12;332(2):80-5. doi: 10.1056/NEJM199501123320203.

DOI:10.1056/NEJM199501123320203

PMID:7990904

Abstract

BACKGROUND

Left ventricular dilatation and neuroendocrine activation are common after acute anterior myocardial infarction. Long-term treatment with an angiotensin-converting-enzyme (ACE) inhibitor may improve outcome by attenuating these processes. We investigated whether the ACE inhibitor zofenopril, administered for six weeks after anterior myocardial infarction, could improve both short-term and long-term outcome.

METHODS

A total of 1556 patients were enrolled within 24 hours after the onset of symptoms of acute anterior myocardial infarction, and they were randomly assigned in a double-blind fashion to receive either placebo (784 patients) or zofenopril (772 patients) for six weeks. At this time we assessed the incidence of death or severe congestive heart failure. The patients were reexamined after one year to assess survival.

RESULTS

The incidence of death or severe congestive heart failure at six weeks was significantly reduced in the zofenopril group (55 patients, 7.1 percent), as compared with the placebo group (83 patients, 10.6 percent); the cumulative reduction in the risk of death or severe congestive heart failure was 34 percent (95 percent confidence interval, 8 to 54 percent; P = 0.018). The reduction in risk was 46 percent (95 percent confidence interval, 11 to 71 percent; P = 0.018) for severe congestive heart failure and 25 percent (95 percent confidence interval, -11 to 60 percent; P = 0.19) for death. After one year of observation, the mortality rate was significantly lower in the zofenopril group (10.0 percent) than in the placebo group (14.1 percent); the reduction in risk was 29 percent (95 percent confidence interval, 6 to 51 percent; P = 0.011).

CONCLUSIONS

Treatment with zofenopril significantly improved both short-term and long-term outcome when this drug was started within 24 hours after the onset of acute anterior myocardial infarction and continued for six weeks.

摘要

背景

急性前壁心肌梗死后左心室扩张和神经内分泌激活很常见。长期使用血管紧张素转换酶（ACE）抑制剂治疗可能通过减轻这些过程来改善预后。我们研究了在急性前壁心肌梗死后给予六周的ACE抑制剂佐芬普利是否能改善短期和长期预后。

方法

共有1556例急性前壁心肌梗死症状发作后24小时内入组的患者，以双盲方式随机分配接受安慰剂（784例患者）或佐芬普利（772例患者）治疗六周。此时我们评估死亡或严重充血性心力衰竭的发生率。一年后对患者进行复查以评估生存率。

结果

与安慰剂组（83例患者，10.6%）相比，佐芬普利组六周时死亡或严重充血性心力衰竭的发生率显著降低（55例患者，7.1%）；死亡或严重充血性心力衰竭风险的累积降低为34%（95%置信区间，8%至54%；P = 0.018）。严重充血性心力衰竭风险降低46%（95%置信区间，11%至71%；P = 0.018），死亡风险降低25%（95%置信区间，-11%至60%；P = 0.19）。观察一年后，佐芬普利组的死亡率（10.0%）显著低于安慰剂组（14.1%）；风险降低29%（95%置信区间，6%至51%；P = 0.011）。