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非奈利酮在急性心力衰竭住院患者中的使用特征与安全性分析
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| 篇名： | 非奈利酮在急性心力衰竭住院患者中的使用特征与安全性分析 |
| TITLE： | Characteristics and safety analysis of finerenone use in hospitalized patients with acute heart failure |
| 摘要： | 目的 探讨非奈利酮在急性心力衰竭（AHF）住院患者中的使用特征与安全性。方法采用单中心回顾性队列研究设计，纳入2023年11月至2026年4月于中国科学技术大学附属第一医院住院期间启动非奈利酮治疗的AHF患者为研究对象，收集其基线特征、非奈利酮使用特征、住院期间主要和次要安全性终点等。采用单变量组间分析、单变量及多变量Logistic回归进行预测因素分析（事件数稀少时采用Firth惩罚似然法），并采用倾向性评分匹配（PSM）和稳定化逆概率加权法（sIPTW）比较早期（≤3d）与中晚期（＞3d）启动非奈利酮的安全性差异。采用敏感性分析验证高钾血症相关结果的稳健性。结果共纳入171例AHF住院患者，射血分数保留者占63.7%。非奈利酮启动中位时间为入院后2d，早期启动者占64.3%，起始剂量10mg、qd者占83.0%，联合钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）使用率为83.6%。全队列高钾血症发生率为3.5%，急性肾损伤发生率为13.5%，复合终点发生率为21.6%。联合SGLT2i在单变量Logistic回归中与高钾风险降低相关（OR＝0.18，95%CI为0.04～0.86，P＝0.032），多变量Logistic回归校正后呈保护趋势但未达统计学意义（OR＝0.24，95%CI为0.05～1.21，P＝0.084）；多变量Logistic回归校正后，基线血钾与复合终点风险独立相关（OR＝2.01，95%CI为1.06～3.82，P＝0.032）。PSM（OR＝0.70，95%CI为0.27～1.83）和sIPTW（OR＝0.70，95%CI为0.32～1.52）分析均显示，早期启动非奈利酮不增加复合终点风险。敏感性分析结果与全队列分析一致。结论纳入患者的非奈利酮启动早、起始剂量合理，联合SGLT2i比例高；其早期启动不增加院内高钾血症或急性肾损伤风险，总体安全性良好，且联合SGLT2i在高钾风险方面呈保护趋势。 |
| ABSTRACT： | OBJECTIVE To investigate the characteristics and safety of finerenone use in hospitalized patients with acute heart failure （AHF）.METHODS A single-center retrospective cohort study was conducted， enrolling 171 AHF patients who initiated finerenone therapy during hospitalization at The First Affiliated Hospital of University of Science and Technology of China between November 2023 and April 2026. Baseline characteristics， finerenone use patterns，in-hospital major and minor safety endpoints were collected. Univariate intergroup analysis， univariate and multivariate Logistic regression were performed to identify predictive factors （Firth’s penalized likelihood method was used when events were sparse）. Propensity score matching （PSM） and stabilized inverse probability of treatment weighting （sIPTW） were employed to compare the safety differences between early initiation （≤3 d） and intermediate-to-late initiation （＞3 d） of finerenone. Sensitivity analysis was conducted to verify the robustness of the hyperkalemia-related results.RESULTS A total of 171 hospitalized patients with AHF were included， with 63.7% having heart failure with preserved ejection fraction. The median time to finerenone initiation was 2 d after admission， with early initiation accounting for 64.3%， an initial dose of 10 mg once daily accounting for 83.0%， and concomitant use of sodium-glucose cotransporter 2 inhibitor （SGLT2i） accounting for 83.6%. In the overall cohort， the incidence of hyperkalemia was 3.5%， the incidence of acute kidney injury was 13.5%， and the incidence of the composite endpoint was 21.6%. Concomitant SGLT2i use was associated with a lower risk of hyperkalemia in univariable Logistic regression （OR＝0.18， 95%CI of 0.04-0.86， P ＝0.032） and showed a trend toward a protective association after multivariable Logistic regression adjustment， although this did not reach statistical significance （OR＝0.24， 95%CI of 0.05-1.21， P ＝0.084）； after multivariable Logistic regression adjustment，baseline serum potassium was independently associated with the risk of the composite endpoint （OR＝2.01， 95%CI of 1.06-3.82， P ＝0.032）. Both PSM（OR＝0.70， 95%CI of 0.27-1.83）and sIPTW（OR＝0.70， 95%CI of 0.32-1.52）analyses showed that early initiation of finerenone did not increase the risk of the composite endpoint. Sensitivity analysis results were consistent with the overall cohort analysis.CONCLUSIONS The enrolled patients initiated finerenone early with reasonable starting doses， and a high proportion received concomitant SGLT2i therapy； early initiation did not increase the risk of in-hospital hyperkalemia or acute kidney injury， with an overall favorable safety profile， and concomitant SGLT2i use showed a protective trend with respect to hyperkalemia risk. |
| 期刊： | 2026年第37卷第20期 |
| 作者： | 舒冰；王齐；方玉婷；殷桐；陈康玉；唐丽琴 |
| AUTHORS： | SHU Bing，WANG Qi，FANG Yuting，YIN Tong，CHEN Kangyu，TANG Liqin |
| 关键字： | 非奈利酮;急性心力衰竭;高钾血症;急性肾损伤;盐皮质激素受体拮抗剂;安全性 |
| KEYWORDS： | finerenone;Acute heart failure;hyperkalemia;Acute kidney injury;mineralocorticoid receptor antagonist;Safety |
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