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急性冠状动脉综合征后危险因素管理的教育计划:一项随机临床试验。

An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial.

机构信息

Service de Cardiologie, Hôpital Saint-Antoine, Assistance Publique des Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France.

currently in private practice, Paris, France.

出版信息

JAMA Intern Med. 2014 Jan;174(1):40-8. doi: 10.1001/jamainternmed.2013.11342.

DOI:10.1001/jamainternmed.2013.11342
PMID:24126705
Abstract

IMPORTANCE

Lifestyle improvements after an acute coronary syndrome reduce cardiovascular risk but are difficult to achieve.

OBJECTIVE

To determine whether a nurse-led or dietician-led cardiovascular risk factor education program would improve risk factor reduction over the long term after an acute coronary syndrome.

DESIGN, SETTING, AND PARTICIPANTS: The Réseau Insuffisance Cardiaque (RESICARD) PREVENTION: study was a 2-arm, parallel-group, multicenter, randomized clinical trial at 6 tertiary care hospitals in France. Patients hospitalized in a cardiac intensive care unit for an acute coronary syndrome with at least 1 lifestyle risk factor (current smoking, sedentary lifestyle, or overweight or obesity) were randomized according to a computer-generated list with sequentially numbered, sealed envelopes.

INTERVENTION

Patients underwent an education program in a unique non-hospital setting (a House of Education) or were treated according to physicians' usual standard of care.

MAIN OUTCOMES AND MEASURES

The primary outcome was a composite that included at least 1 of the following: smoking cessation, at least 3 hours per week of physical activity, at least 5% reduction in weight, and at least 4% reduction in waist circumference. Patients were followed up for 1 year. An intent-to-treat analysis was performed. RESULTS From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the House of Education and 251 to conventional care. The 2 groups did not differ significantly at 12 months in the primary composite outcome (51.8% vs 49.8% success rate; adjusted relative risk [aRR], 1.11; 95% CI, 0.90-1.37) or with correction of all risk factors (aRR, 1.22; 95% CI, 0.89-1.66). Similarly, the 2 groups did not differ by physical activity (aRR, 1.05; 95% CI, 0.92-1.21), smoking cessation (aRR, 0.99; 95% CI, 0.87-1.13), and weight or waist reduction (aRR, 1.07; 95% CI, 0.84-1.36).

CONCLUSIONS AND RELEVANCE

Compared with conventional care, the House of Education did not result in superior improvement in lifestyle-related cardiovascular risk factors after an acute coronary syndrome.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00337480.

摘要

重要性

急性冠状动脉综合征后生活方式的改善可以降低心血管风险,但却难以实现。

目的

确定护士或营养师主导的心血管危险因素教育方案是否会在急性冠状动脉综合征后长期改善危险因素的降低。

设计、地点和参与者:RESICARD PREVENTION 研究是一项在法国 6 家三级护理医院进行的 2 臂、平行组、多中心、随机临床试验。因急性冠状动脉综合征住院的患者被随机分配到心脏重症监护病房,这些患者至少存在 1 种生活方式风险因素(目前吸烟、久坐不动的生活方式或超重或肥胖),随机分配是根据计算机生成的、带有连续编号的密封信封列表进行的。

干预

患者在一个独特的非医院环境(教育之家)中接受教育方案,或按照医生的常规标准进行治疗。

主要结局和测量指标

主要结局是一个复合结局,包括以下至少 1 项:戒烟、每周至少进行 3 小时的体育活动、体重至少减轻 5%、腰围至少减少 4%。患者接受了为期 1 年的随访。进行了意向治疗分析。结果:从 2006 年 6 月 21 日至 2008 年 7 月 30 日,共有 251 名患者被随机分配到教育之家,251 名患者被分配到常规护理组。在 12 个月时,两组在主要复合结局(成功率分别为 51.8%和 49.8%;调整后的相对风险[aRR],1.11;95%CI,0.90-1.37)或所有危险因素的纠正方面均无显著差异(aRR,1.22;95%CI,0.89-1.66)。同样,两组在体力活动(aRR,1.05;95%CI,0.92-1.21)、戒烟(aRR,0.99;95%CI,0.87-1.13)和体重或腰围减少(aRR,1.07;95%CI,0.84-1.36)方面也没有差异。

结论和相关性

与常规护理相比,教育之家在急性冠状动脉综合征后并未显著改善与生活方式相关的心血管危险因素。

试验注册

clinicaltrials.gov 标识符:NCT00337480。

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