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采用多中心随机双盲安慰剂对照临床试验方法,以评估转换酶抑制剂(CEI)卡托普利对急性心肌梗塞(AMI)早期病死率及并发症的影响。全国500家医院共同完成11345例,治疗组5666例,对照组5679例,两组病人的基础临床特征相似。用药(卡托普利12.5mg3/d)后28d治疗组病死率(9.3%)略低于对照组(9.8%)。按死亡原因分析,治疗组死于心力衰竭与室颤者分别较对照组减少15.5%与20.1%。亚组分析提示治疗组前壁心肌梗塞病死率(9.5%)低于对照组(11.0%)(P=0.06);而下壁心肌梗塞病死率(7.5%)则略高于对照组(6.5%)。治疗组除低血压发生率高于对照组外,其他副作用两组相似。本阶段资料揭示卡托普利早期治疗AMI是安全的,可能对前壁心肌梗塞的益处较大,对下壁心肌梗塞则可能无益。最终结果待本试验结束后报告。
A multicenter, randomized, double-blind placebo-controlled clinical trial was conducted to evaluate the effect of captopril, a translational enzyme inhibitor (CEI), on early mortality and complications of acute myocardial infarction (AMI). The country’s 500 hospitals completed 11,345 cases, 5666 cases in the treatment group and 5679 cases in the control group. The basic clinical features of the two groups were similar. After treatment (captopril 12.5mg3 / d) 28d treatment group mortality (9.3%) slightly lower than the control group (9.8%). Analysis of the cause of death, the treatment group died of heart failure and ventricular fibrillation were 15.5% and 20.1% lower than the control group. Subgroup analyzes suggested that the anterior myocardial infarction mortality (9.5%) was lower in the treatment group than in the control group (11.0%) (P = 0.06), whereas the mortality of the inferior myocardial infarction (7.5%) was Slightly higher than the control group (6.5%). The incidence of hypotension in the treatment group was higher than that in the control group, and other side effects were similar in the two groups. This phase of the data reveals that early treatment of AMI with captopril is safe, may have a greater benefit in anterior myocardial infarction, and may not be beneficial in inferior myocardial infarction. The final result is to be reported after the end of this test.