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目的 评价卡托普利对急性心肌梗死 (AMI)患者早期病死率及并发症的影响。方法 采用随机双盲安慰剂对照临床试验方法 ,选择发病 36h内的AMI住院患者 2 494例 ,随机口服卡托普利或相匹配的安慰剂 ,治疗 4周。治疗组 (n =12 6 8例 )与安慰剂组 (n =12 2 6例 )患者基本临床特征相似。结果 治疗组 4周病死率(9 5 4% )低于对照组 (12 15 % ) (P =0 0 36 )。治疗组与对照组比较 ,心衰发生率减少 (15 38%对 18 76 % ,P =0 0 2 5 )。治疗组低血压发生率 (13 96 % )高于对照组 (10 77% ) (P =0 0 16 ) ,但休克发生率两组差异不明显(5 5 2 %对 5 46 % ,P =0 95 1)。治疗组休克者病死率 (5 1 43% )低于对照组 (73 13% ) (P =0 0 0 9)。结论 口服卡托普利有降低AMI 4周病死率的作用 ,主要是减少了心衰的发生并减少了心源性休克的病死率。
Objective To evaluate the effect of captopril on early mortality and complications in patients with acute myocardial infarction (AMI). Methods A randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 2 494 AMI inpatients were selected within 36 hours after onset of therapy. Patients were randomized to either captopril or matched placebo for 4 weeks. The basic clinical characteristics of patients in the treatment group (n = 126 68) and those in the placebo group (n = 122 6) were similar. Results The 4-week mortality rate in the treatment group (95.4%) was lower than that in the control group (121.5%) (P = 0.0036). The incidence of heart failure was lower in the treatment group than in the control group (15 38% versus 18 76%, P = 0 025). The incidence of hypotension in the treatment group (13 96%) was higher than that in the control group (10 77%) (P = 0.0016), but the incidence of shock was insignificantly different between the two groups (52.2% vs 546%, P = 0 95 1). The mortality of the treated group was lower than that of the control group (5 1343%) (73 13%) (P 0 0 0 9). Conclusions Oral captopril has the effect of reducing the 4-week mortality rate of AMI, which mainly reduces the incidence of heart failure and reduces the mortality of cardiogenic shock.