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认知行为疗法与标准治疗预防冠心病患者心血管事件复发的随机对照试验:乌普萨拉初级卫生保健项目中的二级预防(SUPRIM)

Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM).

作者信息

Gulliksson Mats, Burell Gunilla, Vessby Bengt, Lundin Lennart, Toss Henrik, Svärdsudd Kurt

机构信息

Department of Public Health and Caring Sciences, Uppsala University Hospital, Sweden.

出版信息

Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.

DOI:10.1001/archinternmed.2010.510
PMID:21263103
Abstract

BACKGROUND

Psychosocial factors are independently associated with increased risk of cardiovascular disease (CVD) morbidity and mortality, but the effects of psychosocial factor intervention on CVD are uncertain. We performed a randomized controlled clinical trial of cognitive behavioral therapy (CBT) to measure its effects on CVD recurrence.

METHODS

The study included 362 women and men 75 years or younger who were discharged from the hospital after a coronary heart disease event within the past 12 months. Patients were randomized to receive traditional care (reference group, 170 patients) or traditional care plus a CBT program (intervention group, 192 patients), focused on stress management, with 20 two-hour sessions during 1 year. Median attendance at each CBT session was 85%. Outcome variables were all-cause mortality, hospital admission for recurrent CVD, and recurrent acute myocardial infarction.

RESULTS

During a mean 94 months of follow-up, the intervention group had a 41% lower rate of fatal and nonfatal first recurrent CVD events (hazard ratio [95% confidence interval], 0.59 [0.42-0.83]; P = .002), 45% fewer recurrent acute myocardial infarctions (0.55 [0.36-0.85]; P = .007), and a nonsignificant 28% lower all-cause mortality (0.72 [0.40-1.30]; P = .28) than the reference group after adjustment for other outcome-affecting variables. In the CBT group there was a strong dose-response effect between intervention group attendance and outcome. During the first 2 years of follow-up, there were no significant group differences in traditional risk factors.

CONCLUSIONS

A CBT intervention program decreases the risk of recurrent CVD and recurrent acute myocardial infarction. This may have implications for secondary preventive programs in patients with coronary heart disease. Trial Registration clinicaltrials.gov Identifier: NCT00888485.

摘要

背景

社会心理因素与心血管疾病(CVD)发病和死亡风险增加独立相关,但社会心理因素干预对心血管疾病的影响尚不确定。我们进行了一项认知行为疗法(CBT)的随机对照临床试验,以测量其对心血管疾病复发的影响。

方法

该研究纳入了362名75岁及以下的男性和女性,他们在过去12个月内发生冠心病事件后出院。患者被随机分为接受传统护理(参照组,170例患者)或传统护理加CBT方案(干预组,192例患者),CBT方案侧重于压力管理,在1年内进行20次两小时的疗程。每次CBT疗程的中位出勤率为85%。结局变量为全因死亡率、因心血管疾病复发住院以及复发性急性心肌梗死。

结果

在平均94个月的随访期间,干预组首次发生致命和非致命性心血管疾病复发事件的发生率降低了41%(风险比[95%置信区间],0.59[0.42 - 0.83];P = 0.002),复发性急性心肌梗死减少了45%(0.55[0.36 - 0.85];P = 0.007),在对其他影响结局的变量进行调整后,全因死亡率比参照组降低了28%,但差异无统计学意义(0.72[0.40 - 1.30];P = 0.28)。在CBT组中,干预组的出勤率与结局之间存在强烈的剂量反应效应。在随访的前两年,传统危险因素在两组之间无显著差异。

结论

CBT干预方案可降低心血管疾病复发和复发性急性心肌梗死的风险。这可能对冠心病患者的二级预防方案具有启示意义。试验注册 clinicaltrials.gov标识符:NCT00888485。

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