收稿日期: 2025-01-23
网络出版日期: 2025-05-20
基金资助
国家自然科学基金资助项目(82300384);南京鼓楼医院青年培育基金资助项目(2013-LCYJ-PY-34)
Clinical efficacy of vericiguat in combination with "Quadruple Therapy" for patients with heart failure and reduced ejection fraction in real⁃world settings
Received date: 2025-01-23
Online published: 2025-05-20
目的 评估维立西呱联合“新四联”药物治疗射血分数降低型心力衰竭(heart failure with reduced ejection fraction, HFrEF)的临床疗效与安全性,并探讨其对不同基线特征患者左室逆重构(left ventricular reverse remodeling, LVRR)的影响。 方法 连续纳入2022年6月至2024年3月于南京大学医学院附属鼓楼医院心内科接受维立西呱治疗的慢性心力衰竭患者87例作为观察组,并按年龄、性别及左室射血分数(left ventricular ejection fraction, LVEF)1∶1匹配未使用维立西呱的87例患者作为对照组。采用倾向性评分匹配法进一步平衡混杂因素,最终各保留64例患者对结果加以验证。通过分析两组患者在基线和6个月随访期间超声心动图参数、肝肾功能、电解质水平以及血压的变化,评估维立西呱对HFrEF患者的疗效和安全性。主要疗效终点为患者发生LVRR。基于年龄、性别等基线特征展开亚组分析,并通过交互作用评估维立西呱的疗效异质性。 结果 6个月治疗期间,维立西呱组患者的心脏结构和功能较对照组改善明显,左室舒张末期内径显著降低[-0.43(-1.00,-0.10) mm vs.-0.22(-0.53,0.02) mm, P = 0.002]、LVEF显著升高[8.45%(1.40%,16.50%) vs. 2.75%(0,11.00%), P = 0.002]、发生LVRR的患者更多(46.4% vs. 27.4%,P = 0.011),多因素logistic回归证实,联用维立西呱是LVRR的独立危险因素(OR = 2.54, 95%CI: 1.29 ~ 5.01, P = 0.007),且逆转重构的效果不受特定基线特征的影响,在不同亚组间无显著异质性(P交互 > 0.05)。在安全性方面,联用维立西呱不会对血压、肝肾功能以及电解质水平造成影响,但胃肠道反应的发生率增高(16.1% vs. 5.7%, P < 0.001)。 结论 在四联疗法的基础上联用维立西呱可以在确保安全性的同时显著改善HFrEF患者的心脏功能并逆转其左心室重构。
陈琳 , 邬保川 , 吴少军 , 王奕 , 付毅蓓 , 刘晓丽 , 顾蓉 . 真实世界中维立西呱联合“四联疗法”对射血分数降低型心力衰竭的疗效[J]. 实用医学杂志, 2025 , 41(9) : 1379 -1386 . DOI: 10.3969/j.issn.1006-5725.2025.09.016
Objective To evaluate the clinical efficacy and safety of vericiguat combined with the new “Quadruple Therapy” for treating heart failure with reduced ejection fraction(HFrEF) and to explore its impact on left ventricular reverse remodeling(LVRR) in patients with different baseline characteristics. Methods A total of 87 patients with chronic heart failure treated with vericiguat at the Department of Cardiology, Nanjing Drum Tower Hospital from June 2022 to March 2024, were consecutively enrolled as the observation group. These patients were matched at 1∶1 by age, sex, and left ventricular ejection fraction(LVEF) with 87 patients who received the standard quadruple therapy without vericiguat as the control group. Propensity score matching was used to further balance confounding factors, resulting in 64 patients in each group for final analysis. Changes in echocardiographic parameters, liver and kidney function, electrolyte levels, and blood pressure were analyzed at baseline and during the 6-month follow-up to assess the efficacy and safety of vericiguat. The primary efficacy endpoint was the occurrence of LVRR. Subgroup analyses were conducted based on baseline characteristics such as age and sex. Interaction analysis was utilized to evaluate the heterogeneity of vericiguat's efficacy. Results After 6 months of treatment, the vericiguat group showed significant improvements in cardiac structure and function compared to the control group. The left ventricular end-diastolic diameter was significantly reduced [-0.43(-1.00,-0.10) mm vs.-0.22(-0.53,0.02) mm, P = 0.002], and the LVEF was significantly increased [8.45%(1.40%,16.50%) vs. 2.75%(0,11.00%), P = 0.002]. The percentage of patients in the vericiguat group who achieved LVRR was significantly larger than in the control group(46.4% vs. 27.4%, P = 0.011). Multivariate logistic regression revealed that the combination of vericiguat was an independent predictor of LVRR(Model 2: OR = 2.54, 95% CI: 1.29 ~ 5.01, P = 0.007). The reverse remodeling effect remained consistent across different subgroups and was not significantly influenced by specific baseline characteristics(Pinteraction > 0.05). Vericiguat did not affect blood pressure, liver and kidney function, or electrolyte levels, achieving satisfactory safety, despite its significantly higher incidence of gastrointestinal reactions(16.1% vs. 5.7%, P < 0.001). Conclusion The addition of vericiguat to the quadruple therapy significantly improves cardiac function and promotes left ventricular reverse remodeling in HFrEF patients while maintaining a favorable safety profile.
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