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地高辛与心力衰竭患者死亡率及住院率的降低:地高辛研究(DIG)的全面事后分析

Digoxin and reduction in mortality and hospitalization in heart failure: a comprehensive post hoc analysis of the DIG trial.

作者信息

Ahmed Ali, Rich Michael W, Love Thomas E, Lloyd-Jones Donald M, Aban Inmaculada B, Colucci Wilson S, Adams Kirkwood F, Gheorghiade Mihai

机构信息

University of Alabama at Birmingham, VA Medical Center, 1530 3rd Avenue South, CH-19, Ste-219, Birmingham, AL 35294-2041, USA.

出版信息

Eur Heart J. 2006 Jan;27(2):178-86. doi: 10.1093/eurheartj/ehi687. Epub 2005 Dec 8.

DOI:10.1093/eurheartj/ehi687
PMID:16339157
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2685167/
Abstract

AIMS

To determine the effects of digoxin on all-cause mortality and heart failure (HF) hospitalizations, regardless of ejection fraction, accounting for serum digoxin concentration (SDC).

METHODS AND RESULTS

This comprehensive post-hoc analysis of the randomized controlled Digitalis Investigation Group trial (n=7788) focuses on 5548 patients: 1687 with SDC, drawn randomly at 1 month, and 3861 placebo patients, alive at 1 month. Overall, 33% died and 31% had HF hospitalizations during a 40-month median follow-up. Compared with placebo, SDC 0.5-0.9 ng/mL was associated with lower mortality [29 vs. 33% placebo; adjusted hazard ratio (AHR), 0.77; 95% confidence interval (CI), 0.67-0.89], all-cause hospitalizations (64 vs. 67% placebo; AHR, 0.85; 95% CI, 0.78-0.92) and HF hospitalizations (23 vs. 33% placebo; AHR, 0.62; 95% CI, 0.54-0.72). SDC> or =1.0 ng/mL was associated with lower HF hospitalizations (29 vs. 33% placebo; AHR, 0.68; 95% CI, 0.59-0.79), without any effect on mortality. SDC 0.5-0.9 reduced mortality in a wide spectrum of HF patients and had no interaction with ejection fraction >45% (P=0.834) or sex (P=0.917).

CONCLUSIONS

Digoxin at SDC 0.5-0.9 ng/mL reduces mortality and hospitalizations in all HF patients, including those with preserved systolic function. At higher SDC, digoxin reduces HF hospitalization but has no effect on mortality or all-cause hospitalizations.

摘要

目的

确定地高辛对全因死亡率和心力衰竭(HF)住院率的影响,无论射血分数如何,并考虑血清地高辛浓度(SDC)。

方法与结果

这项对随机对照的地高辛研究组试验(n = 7788)进行的全面事后分析聚焦于5548例患者:1687例在1个月时随机抽取的有SDC数据的患者,以及3861例在1个月时存活的安慰剂组患者。总体而言,在40个月的中位随访期内,33%的患者死亡,31%的患者因HF住院。与安慰剂相比,SDC为0.5 - 0.9 ng/mL与较低的死亡率相关[安慰剂组为33%,SDC为0.5 - 0.9 ng/mL组为29%;调整后风险比(AHR)为0.77;95%置信区间(CI)为0.67 - 0.89]、全因住院率(安慰剂组为67%,SDC为0.5 - 0.9 ng/mL组为64%;AHR为0.85;95% CI为0.78 - 0.92)以及HF住院率(安慰剂组为33%,SDC为0.5 - 0.9 ng/mL组为23%;AHR为0.62;95% CI为0.54 - 0.72)。SDC≥1.0 ng/mL与较低的HF住院率相关(安慰剂组为33%,SDC≥1.0 ng/mL组为29%;AHR为0.68;95% CI为0.59 - 0.79),但对死亡率无任何影响。SDC为0.5 - 0.9可降低广泛类型HF患者的死亡率,且与射血分数>45%(P = 0.834)或性别(P = 0.917)无相互作用。

结论

SDC为0.5 - 0.9 ng/mL的地高辛可降低所有HF患者的死亡率和住院率,包括收缩功能保留的患者。在较高的SDC水平下,地高辛可降低HF住院率,但对死亡率或全因住院率无影响。

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