近日，加拿大麦克马斯特大学Michael Walsh团队研究了类固醇盐皮质激素受体拮抗剂治疗需要透析的肾功能衰竭患者对心血管预后的影响。相关论文于2025年8月18日发表在《柳叶刀》杂志上。

矿皮质激素受体拮抗剂可以预防心力衰竭和非严重慢性肾脏疾病患者的心血管事件，但其对需要透析的肾衰竭患者的作用尚不确定。该研究旨在评估矿皮质激素受体拮抗剂在该患者群体中的有效性和安全性。

在这篇系统评价和荟萃分析中，研究组通过检索MEDLINE、Embase、Cochrane中央对照试验注册库以及护理和相关健康文献累积索引，更新了之前的系统综述，检索数据库建立至2025年3月18日期间发表的随机对照试验。在接受维持性透析的成人（年龄≥18岁）中，比较矿皮质激素受体拮抗剂与安慰剂或标准护理的试验是合格的。未报告相关结果（心血管死亡率、心力衰竭住院、全因死亡率、全因住院、高钾血症、妇科乳房发育或乳房疼痛或低血压）的研究被排除在外。两位审稿人独立识别研究，提取数据，并使用Cochrane风险偏倚工具评估偏倚风险。主要结局是心血管死亡率，使用经验贝叶斯随机效应模型进行评估，并按偏倚风险分层。协议注册在PROSPERO （CRD420251008119）。

19项甾体矿皮质激素受体拮抗剂的试验，包括4675名受试者符合资格标准。低偏倚风险和高偏倚风险试验的效果估计不同。在4项低偏倚风险试验（n=3562）中，矿皮质激素受体拮抗剂组1785例患者中有264例心血管死亡，而对照组1777例患者中有276例心血管死亡(优势比0.98；I² = 0·0%;τ2 = 0.0;中度确定性)，导致每年每1000例患者的绝对风险减少1例（95% CI减少14例至11例）。

研究结果提示甾体矿皮质激素受体拮抗剂对需要透析的患者心血管死亡率几乎没有影响。关于类固醇类固醇皮质激素受体拮抗剂对透析患者亚组的影响的信息不足，而关于非类固醇类固醇皮质激素受体拮抗剂的信息则没有。未来的试验将需要考虑只有较小影响的可能性，或影响仅限于患者或病理生理事件，在其设计中更明显是由醛固酮驱动的。

附：英文原文

Title: Safety and efficacy of steroidal mineralocorticoid receptor antagonists in patients with kidney failure requiring dialysis: a systematic review and meta-analysis of randomised controlled trials

Author: Lonnie Pyne, Patrick Rossignol, Cameron Giles, Mats Junek, Patrick B Mark, Martin Gallagher, Janak R de Zoysa, P J Devereaux, Michael Walsh

Issue&Volume: 2025-08-18

Abstract:

Background

Mineralocorticoid receptor antagonists can prevent cardiovascular events in patients with heart failure and non-severe chronic kidney disease, but their effects in patients with kidney failure requiring dialysis are uncertain. We aimed to assess the efficacy and safety of mineralocorticoid receptor antagonists in this patient population.

Methods

In this systematic review and meta-analysis, we updated our previous systematic review by searching MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature for randomised controlled trials published between database inception and March 18, 2025. Trials comparing a mineralocorticoid receptor antagonist with placebo or standard of care in adults (aged ≥18 years) receiving maintenance dialysis were eligible. Studies that did not report an outcome of interest (cardiovascular mortality, heart failure hospitalisation, all-cause mortality, all-cause hospitalisation, hyperkalaemia, gynaecomastia or breast pain, or hypotension) were excluded. Two reviewers independently identified studies, extracted data, and assessed the risk of bias using the Cochrane risk-of-bias tool. The main outcome was cardiovascular mortality assessed using the empirical Bayes random-effects models, stratified by risk-of-bias. The protocol is registered with PROSPERO (CRD420251008119).

Findings

19 trials of steroidal mineralocorticoid receptor antagonists including 4675 participants met eligibility criteria. Effect estimates differed trials with low and high risk of bias. In four trials with a low risk of bias (n=3562), 264 cardiovascular deaths occurred in 1785 patients in the mineralocorticoid receptor antagonist group compared with 276 of 1777 patients in the control group (odds ratio 0·98 [95% CI 0·80–1·20]; I2=0·0%; τ2=0·0; moderate certainty) resulting in an absolute risk reduction of 1 fewer event per 1000 patients per year (95% CI 14 fewer to 11 more).

Interpretation

Our findings suggest that steroidal mineralocorticoid receptor antagonists have little to no effect on cardiovascular mortality in patients requiring dialysis. There is insufficient information on the effects of steroidal mineralocorticoid receptor antagonists in subgroups of patients requiring dialysis and no information on non-steroidal mineralocorticoid receptor antagonists. Future trials would need to consider the likelihood of only smaller effects or effects limited to patients or events with pathophysiology that is more clearly driven by aldosterone in their design.

DOI: 10.1016/S0140-6736(25)01153-5

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01153-5/abstract