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自评健康状况可预测β受体阻滞剂治疗期间的不良事件:CIBIS-ELD 随机试验分析。

Self-rated health predicts adverse events during β-blocker treatment: the CIBIS-ELD randomised trial analysis.

机构信息

Division of Cardiology, University Clinic Golnik, Golnik, Slovenia.

出版信息

Int J Cardiol. 2013 Feb 10;163(1):87-92. doi: 10.1016/j.ijcard.2011.05.037. Epub 2011 Jun 8.

DOI:10.1016/j.ijcard.2011.05.037
PMID:21652093
Abstract

BACKGROUND

Self-rated health (SRH) predicts outcome in patients with heart failure. Beta-blockers are known to improve health-related quality of life and reduce mortality in such patients. We aimed to evaluate the relation between SRH and adverse events during titration of beta-blockers in elderly patients with heart failure.

METHODS

The cardiac insufficiency bisoprolol study in the elderly (CIBIS-ELD) is a multicentre, double-blind trial, in which 883 patients aged ≥ 65 years with chronic heart failure (73 ± 6 years, 38% women, left ventricular ejection fraction [LVEF] 42% ± 14%) were randomised to bisoprolol or carvedilol. SRH was assessed at baseline and after 12 weeks, using a 5-grade descriptive scale: excellent, very good, good, fair, and poor.

RESULTS

Median SRH at baseline and follow-up was good, but more patients reported fair/poor SRH at baseline (36% vs. 30%, p = 0.012). Women, beta-blocker-naïve patients, patients in NYHA class III/IV and those with PHQ-9 score ≥ 12 were more likely to report fair/poor baseline SRH (p < 0.001 for all). During follow-up, SRH improved in 34% of patients and worsened in 8% (p < 0.001). Adverse events were experienced by 64% patients and 38% experienced > 1 adverse event or serious adverse event, with higher prevalence in lower SRH categories. In a multivariate logistic regression model, SRH, age, distance achieved on the 6-min walk test and LVEF >45% predicted adverse events (p < 0.05 for all).

CONCLUSIONS

SRH is an independent predictor of adverse events during titration of beta-blockers and correlates with the proportion and number of adverse events per patient.

摘要

背景

自评健康(SRH)可预测心力衰竭患者的预后。β受体阻滞剂已知可改善此类患者的健康相关生活质量并降低死亡率。我们旨在评估 SRH 与老年心力衰竭患者β受体阻滞剂滴定期间不良事件之间的关系。

方法

老年充血性心力衰竭比索洛尔研究(CIBIS-ELD)是一项多中心、双盲试验,纳入了 883 名年龄≥65 岁的慢性心力衰竭患者(73±6 岁,38%为女性,左心室射血分数[LVEF]为 42%±14%),随机分为比索洛尔或卡维地洛组。使用 5 级描述性量表在基线和 12 周后评估 SRH:优秀、很好、好、一般和差。

结果

基线和随访时的中位 SRH 均为好,但更多患者在基线时报告一般/差的 SRH(36%比 30%,p=0.012)。女性、β受体阻滞剂初治患者、NYHA 心功能分级 III/IV 级患者和 PHQ-9 评分≥12 的患者更可能报告基线时一般/差的 SRH(所有 p<0.001)。随访期间,34%的患者 SRH 改善,8%的患者恶化(p<0.001)。64%的患者发生了不良事件,38%的患者发生了>1 次不良事件或严重不良事件,较低的 SRH 类别中发生率更高。在多变量逻辑回归模型中,SRH、年龄、6 分钟步行试验的距离和 LVEF>45%预测不良事件(所有 p<0.05)。

结论

SRH 是β受体阻滞剂滴定期间不良事件的独立预测因子,与每个患者的不良事件比例和数量相关。

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