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冠状动脉搭桥手术后低剂量阿司匹林(100毫克/天):一项安慰剂对照试验。

Low-dose acetylsalicylic acid (100 mg/day) after aortocoronary bypass surgery: a placebo-controlled trial.

作者信息

Meister W, von Schacky C, Weber M, Lorenz R, Kotzur J, Reichart B, Theisen K, Weber P C

出版信息

Br J Clin Pharmacol. 1984 Jun;17(6):703-11. doi: 10.1111/j.1365-2125.1984.tb02407.x.

Abstract

The effect of low-dose acetylsalicylic acid (100 mg/day) upon bypass patency-rate and clinical course after aortocoronary bypass surgery was investigated in a randomized, placebo-controlled clinical trial. Sixty patients with 143 distal anastomoses of bypasses were randomized, 46 underwent repeat angiography after 4 months. Using the intention to treat-strategy, treatment was superior to placebo as judged by bypass patency rate and occurrence of cardiovascular complications or death. Counting the six drop-outs as failures, only nine of the 31 patients of the placebo group, but 16 of the 29 patients of the treatment group were considered successes (P less than 0.04). Eighteen patients in the placebo group and eight patients of the treatment group received beta-adrenoceptor blockers postoperatively, suggesting again a favourable effect of the treatment. Adverse drug reactions were very rare and minor. Supported by pathophysiological insights and positive trends in similar trials, the positive result justifies the recommendation of prescribing 100 mg of acetylsalicylic acid once daily to all patients without contraindications after aortocoronary bypass surgery. The positive result of this trial warrants further clinical trials of low-dose acetylsalicylic acid for other indications in arterial diseases.

摘要

在一项随机、安慰剂对照的临床试验中,研究了低剂量阿司匹林(100毫克/天)对主动脉冠状动脉搭桥手术后搭桥通畅率和临床病程的影响。60例患者的143处搭桥远端吻合口被随机分组,46例在4个月后接受了重复血管造影。采用意向性治疗策略,从搭桥通畅率以及心血管并发症或死亡的发生率判断,治疗组优于安慰剂组。将6例退出研究的患者计为失败,安慰剂组31例患者中只有9例被视为成功,而治疗组29例患者中有16例被视为成功(P<0.04)。安慰剂组18例患者和治疗组8例患者术后接受了β-肾上腺素受体阻滞剂治疗,这再次表明治疗组有良好效果。药物不良反应非常罕见且轻微。基于病理生理学见解以及类似试验中的积极趋势,这一阳性结果证明了对所有无禁忌证的主动脉冠状动脉搭桥手术后患者推荐每日服用100毫克阿司匹林的合理性。该试验的阳性结果值得对低剂量阿司匹林用于动脉疾病的其他适应证开展进一步的临床试验。

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