Efficacy and Safety of Digitalis Glycosides in Heart Failure: A Meta-Analysis.

Background

To assess the effect of digitalis glycosides on clinical outcomes in patients with HFmrEF or HFrEF.

评估地高辛苷类药物对HFmrEF或HFrEF患者临床结果的影响。

data_sources_and_study_selection

PubMed was searched from inception to March 1, 2026, using medical subject headings and keywords related to digitalis glycosides and HF.

从PubMed创建开始至2026年3月1日，使用与地高辛苷类和心力衰竭相关的医学主题词和关键词进行搜索。

The review was restricted to placebo-controlledrandomized clinical trials including more than 1000 patients and articles published in the English language.

综述仅限于包括超过1000名患者且为随机安慰剂对照临床试验的文章，并且仅限于以英语发表的文献。

data_extraction_and_synthesis

Data were extracted by 2 reviewers who followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline.

数据由两位审查员根据系统评价和荟萃分析报告的首选报告项目指南提取。

Risk of bias was assessed with the Cochrane Risk of Bias tool (version 2).

使用Cochrane偏倚风险工具（第2版）评估偏倚风险。

A fixed-effects model was used to estimate the hazard ratios (HRs) with 95% CIs.

使用固定效应模型估计风险比（HRs）及其95%置信区间。

main_outcomes_and_measures

The primary end point was the composite of time to cardiovascular death or first worsening HF event.

主要终点是心血管死亡或首次恶化心力衰竭事件的时间复合终点。

Secondary outcomes included individual components of the composite outcome and time to all-cause death.

次要结果包括复合结果的各个组成部分以及全因死亡的时间。

Results

A total of 3 studies met the inclusion criteria and included 9013 patients with HFmrEF or HFrEF (weighted mean age, 64.5 [weighted SD, 11.2] years; 22% female and 78% male).

共有3项研究符合纳入标准，包括9013名中度射血分数保留心力衰竭（HFmrEF）或射血分数降低心力衰竭（HFrEF）患者（加权平均年龄64.5岁[加权标准差11.2]；女性占22%，男性占78%）。

The composite outcome of cardiovascular death or first worsening HF event occurred in 1852 of 4510 patients (41%) in the digitalis glycoside group vs 2037 of 4503 patients (45%) in the placebo group (HR, 0.85 [95% CI, 0.80-0.90]; P < .001).

在4510名患者中，有1852名（41%）在地高辛组发生了心血管死亡或首次心力衰竭恶化事件，而在4503名患者中，有2037名（45%）在安慰剂组发生了这一复合结果（风险比，0.85 [95% 置信区间，0.80-0.90]；P < .001）。

First worsening HF event occurred in 1183 (26%) patients in the digitalis glycoside group vs 1474 (33%) patients in the placebo group (HR, 0.75 [95% CI, 0.69-0.81]; P < .001).

首次心力衰竭恶化事件在地高辛组的1183名（26%）患者中发生，而在安慰剂组的1474名（33%）患者中发生（风险比，0.75 [95% 置信区间，0.69-0.81]；P < .001）。

There were 1224 cardiovascular events in the digitalis glycoside group vs 1224 in the placebo group (27% of participants in each group; HR, 0.99 [95% CI, 0.92-1.07]; P = .81) and there were 1466 vs 1497, respectively, all-cause deaths (32% of participants vs 33%; HR, 0.97 [95% CI, 0.90-1.04]; P = .41).

在地高辛苷类药物组有1224例心血管事件，安慰剂组也有1224例（每组27%的参与者；风险比，0.99 [95% 置信区间，0.92-1.07]；P = .81），全因死亡分别为1466例和1497例（参与者中分别为32%和33%；风险比，0.97 [95% 置信区间，0.90-1.04]；P = .41）。

There was no statistically significant heterogeneity by trial, type of digitalis glycoside treatment, or extent of background HF therapy.

在试验、地高辛苷类药物治疗类型或基础心力衰竭治疗程度方面，没有统计学上的显著异质性。

conclusions_and_relevance

Treatment with digitalis glycosides was associated with a lower risk of the composite of cardiovascular death or first worsening HF event in patients with HFmrEF or HFrEF, mainly through a lower risk of worsening HF events.

在心力衰竭中度或重度射血分数降低（HFmrEF或HFrEF）的患者中，使用地高辛苷类药物与心血管死亡或首次心力衰竭恶化事件的复合风险降低相关，主要是通过降低心力衰竭恶化事件的风险。

There was no statistically significant interaction with important study characteristics, including the extent of HF background therapy or type of digitalis glycosides treatment.

与重要的研究特征，包括心力衰竭背景治疗的程度或地高辛苷类药物治疗的类型，没有统计学上的显著相互作用。

These results suggest digitalis glycosides may be used as additional medical therapy to reduce worsening HF events in patients with HFmrEF or HFrEF.

这些结果表明，地高辛苷类药物可能被用作额外的医疗治疗，以减少中度射血分数保留心力衰竭（HFmrEF）或低射血分数心力衰竭（HFrEF）患者心力衰竭恶化的事件。