血管紧张素转换酶抑制剂卡托普利早期治疗急性心肌梗塞随机临床试验──全国多中心大规模随机双盲安慰剂对照临床试验11345例阶段小结

Early Intervention with ACE Inhibitor Captopril in Acute Myocardial Infarction──Chinese Multicenter, Large-scale, Randomized, Double-blind, Placebo-controlled Clinical Trial (Preliminary Analysis of 11345 Cases)

  • 摘要: 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。

     

    Abstract: This trial was designed to explore the effects of captopril in patients with acute myocardial infarction (AMI ) treated within 36 hours after the onset. Patients received either captopril (C) or placebo (P) 12. 5 mg 3/d to the end of 4weeks. Of the 11345 cases accomplished by over 500 hospitals,5666 were randomly assigned to group C and 5679 to group P.Their baseline clinical characteristics were similar, total mortality in group C (9. 3%) was lower than that in group P(9. 8% )(P = 0. 36 ). Causes of death analysis showed that the death from heart failure and ventricular fibrillation decreased by about 15. 5% and 20. 1 % in group C than in control. Subgroup analysis suggested that the mortality of anterior myocardial infarction in group C (9. 5%) was lower than in control (11. 0% ) (P = 0. 06 ), but mortality of inferior myocardial infarction in group C (7. 5% ) was higher than control (6. 5 % )(P=0. 3). Incidence of hypotension in group C increased more than in group P, but no difference was found between the two groups in other side effects. The initial results showed that inpatients with AMI captopril is safe. Although the overall mortality reduced is small,better results in anterior myocardial infarction is worth further investigation. Now, the trial is still ongoing, a data monitoring committee is closely following the trial results.

     

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