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一项关于普萘洛尔治疗急性心肌梗死患者的随机试验。I. 死亡率结果。

A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results.

出版信息

JAMA. 1982 Mar 26;247(12):1707-14. doi: 10.1001/jama.1982.03320370021023.

DOI:10.1001/jama.1982.03320370021023
PMID:7038157
Abstract

The beta-Blocker Heart Attack Trial (BHAT) was a National Heart, Lung, and Blood Institute-sponsored, multicenter, randomized, double-blind, and placebo-controlled trial designed to test whether the regular administration of propranolol hydrochloride to men and women who had experienced at least one myocardial infarction would result in a significant reduction in total mortality during a two- to four-year period. During a 27-month interval, 3,837 persons between the ages of 30 and 69 years were randomized to either propranolol (1,916 persons) or placebo (1,912 persons), five to 21 days after the infarction. Depending on serum drug levels, the prescribed maintenance dose of propranolol hydrochloride was either 180 or 240 mg/day. The trial was stopped nine months ahead of schedule. Total mortality during the average 24-month follow-up period was 7.2% in the propranolol group and 9.8% in the placebo group. Arteriosclerotic heart disease (ASHD) mortality was 6.2% in the propranolol group and 8.5% in the placebo group. Sudden cardiac death, a subset of ASHD mortality, was 3.3% among the propranolol patients and 4.6% among the placebo patients. Serious side effects were uncommon. Hypotension, gastrointestinal problems, tiredness, bronchospasm, and cold hands and feet occurred more frequently in the propranolol group. Based on the BHAT results, the use of propranolol in patients with no contraindications to beta-blockade who have had a recent myocardial infarction is recommended for at least three years.

摘要

β受体阻滞剂心肌梗死试验(BHAT)是一项由美国国立心肺血液研究所资助的多中心、随机、双盲、安慰剂对照试验,旨在测试对至少经历过一次心肌梗死的男性和女性定期给予盐酸普萘洛尔是否会在两到四年内显著降低总死亡率。在27个月的时间里,3837名年龄在30至69岁之间的人在心肌梗死后五到二十一天被随机分为普萘洛尔组(1916人)或安慰剂组(1912人)。根据血清药物水平,盐酸普萘洛尔的规定维持剂量为每日180毫克或240毫克。该试验提前九个月停止。在平均24个月的随访期内,普萘洛尔组的总死亡率为7.2%,安慰剂组为9.8%。动脉粥样硬化性心脏病(ASHD)死亡率在普萘洛尔组为6.2%,在安慰剂组为8.5%。心源性猝死是ASHD死亡率的一个子集,在普萘洛尔组患者中为3.3%,在安慰剂组患者中为4.6%。严重副作用并不常见。普萘洛尔组低血压、胃肠道问题、疲劳、支气管痉挛以及手脚冰凉的发生率更高。基于BHAT的结果,建议对近期发生心肌梗死且无β受体阻滞剂使用禁忌的患者使用普萘洛尔至少三年。

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