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GDMT方案加用维立西呱治疗射血分数降低型心力衰竭的有效性和安全性
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| 篇名： | GDMT方案加用维立西呱治疗射血分数降低型心力衰竭的有效性和安全性 |
| TITLE： | Efficacy and safety of vericiguat added to GDMT regimen in the treatment of heart failure with reduced ejection fraction |
| 摘要： | 目的 评估指南指导的药物治疗（GDMT）方案加用维立西呱治疗射血分数降低型心力衰竭（HFrEF）的有效性和安全性。方法回顾性选择2023年1月至2024年5月在常州市第一人民医院接受规范化诊疗的HFrEF患者346例为研究对象，分为标准治疗组（n＝215）和维立西呱组（n＝131）。标准治疗组患者采用GDMT方案，维立西呱组患者采用GDMT加用维立西呱方案。采用倾向评分匹配（PSM）法平衡组间混杂因素，并评估两组患者有效性（包括结局指标和预后判断指标）和安全性（不良事件发生情况）。绘制主要和次要结局事件的Kaplan-Meier生存曲线，并通过单因素、多因素Cox回归分析筛选主要结局复合终点事件的影响因素。结果PSM后，标准治疗组和维立西呱组患者各100例，两组患者的基线资料比较，差异均无统计学意义（P＞0.05）。随访1年，标准治疗组和维立西呱组患者的主要结局复合终点事件累积发生率、因心力衰竭住院事件累积发生率、治疗前后的氨基末端脑利钠肽前体变化值差异均有统计学意义（P＜0.05）。两组患者的不良事件发生率比较，差异无统计学意义（P＞0.05）。多因素Cox回归分析结果显示，患者左室射血分数≤35%是1年内发生复合终点事件的危险因素[风险比（HR）＝2.090，95%置信区间（CI）（1.175，3.718），P＝0.012]，使用维立西呱是1年内发生复合终点事件的保护因素[HR＝0.505，95%CI（0.284，0.899），P＝0.020]。结论与GDMT方案比较，GDMT加用维立西呱方案可改善HFrEF患者的临床症状及预后，且安全性良好。 |
| ABSTRACT： | OBJECTIVE To evaluate the efficacy and safety of guideline-directed medical therapy （GDMT） combined with vericiguat in treating heart failure with reduced ejection fraction （HFrEF）. METHODS A retrospective study was conducted on 346 patients with HFrEF who received standardized diagnosis and treatment at the First People’s Hospital of Changzhou from January 2023 to May 2024. They were divided into standard treatment group （n＝215） and vericiguat group （n＝131）. Patients in the standard treatment group received GDMT， while patients in the vericiguat group received GDMT combined with vericiguat. Propensity score matching （PSM） was used to balance confounding factors between two groups， and the effectiveness （including outcome and prognostic indicators） and safety （occurrence of adverse events） of both groups were evaluated. Kaplan-Meier survival curves for primary and secondary outcome events were drawn， and the influential factors of primary outcome events were screened through univariate and multivariate Cox regression analysis. RESULTS After PSM， there were 100 patients in the standard treatment group and 100 patients in the vericiguat group， and there was no statistically significant differences in baseline data between two groups （P＞0.05）. During a 1-year follow-up， there were statistically significant differences in the cumulative incidence of major outcome events between the standard treatment group and the vericiguat group， cumulative incidence of hospitalization events due to heart failure， changes in N-terminal pro-B-type natriuretic peptide levels before and after treatment between the standard treatment group and the vericiguat group （P＜0.05）. There was no statistically significant difference in the incidence of adverse events between the two groups （P＞0.05）. Multivariate Cox regression analysis results showed that left ventricular ejection fraction ≤35% was a risk factor for the occurrence of major outcome events within 1 year [hazard ratio （HR）＝ 2.090， 95% confidence interval （CI）： 1.175-3.718， P＝0.012]， while the use of vericiguat was a protective factor for the occurrence of major outcome events within 1 year （HR＝0.505， 95%CI： 0.284-0.899， P＝0.020）. CONCLUSIONS Compared with GDMT， GDMT combined with vericiguat can improve the clinical symptoms and prognosis of HFrEF patients， and has good safety. |
| 期刊： | 2025年第36卷第17期 |
| 作者： | 赵兴媛；陈祥燕；胡楠；王莉英；薛晖；夏宗玲 |
| AUTHORS： | ZHAO Xingyuan，CHEN Xiangyan，HU Nan，WANG Liying，XUE Hui，XIA Zongling |
| 关键字： | 维立西呱；射血分数降低型心力衰竭；真实世界研究；预后 |
| KEYWORDS： | vericiguat； heart failure with reduced ejection |
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