达格列净在阵发性心房颤动合并射血分数保留型心力衰竭中的作用：一项随机对照研究

连晓雨; 彭飞; 龚辉; 钱菊英

doi:10.12025/j.issn.1008-6358.2025.20250497

达格列净在阵发性心房颤动合并射血分数保留型心力衰竭中的作用：一项随机对照研究

Effect of dapagliflozin in paroxysmal atrial fibrillation combined with heart failure with preserved ejection fraction: a randomized controlled trial

摘要

摘要:
目的探讨达格列净在阵发性心房颤动（paroxysmal atrial fibrillation，PAF）合并射血分数保留型心力衰竭（heart failure with preserved ejection fraction，HFpEF）患者中的有效性及安全性。
方法选取2022年7月至2023年7月于复旦大学附属金山医院就诊的PAF合并HFpEF患者120例，按照随机数字表法分为达格列净组（n＝60，标准治疗基础上联合达格列净）和对照组（n＝60，标准治疗基础上给予安慰剂）。随访12个月，比较两组患者堪萨斯城心肌病问卷总症状评分（Kansas City Cardiomyopathy Questionnaire-Total Symptom Score，KCCQ-TSS）、PAF发作持续时间、PAF再发率及发作次数、左房内径、左心室收缩末期内径、左心室舒张末期内径、左心室射血分数、P波离散度、血压、血浆氨基末端脑利钠肽前体（N-terminal pro-brain natriuretic peptide，NT-proBNP）、估算肾小球滤过率、糖化血红蛋白（glycated hemoglobin A_1C，HbA_1C）等指标，观察治疗期间患者心血管结局和不良事件情况。
结果共10例患者失访，最终110例患者纳入分析（达格列净组55例、对照组55例）。治疗12个月后，达格列净组KCCQ-TSS显著高于对照组（61.68±2.65）分 vs（44.98±4.76）分，P＜0.001，达格列净组PAF发作持续时间显著短于对照组（144±18）min vs（270±24）min，P＝0.045。治疗后两组PAF发作次数、NT-proBNP、左心室收缩末期内径、左心室舒张末期内径、左房内径、P波离散度、HbA_1C差异均有统计学意义（P＜0.05）。达格列净组心力衰竭再住院率和PAF再发率显著低于对照组（P＜0.05）。两组治疗期间的不良事件发生率差异无统计学意义。
结论达格列净可提高PAF合并HFpEF患者的生活质量，缩短PAF发作持续时间，减少心力衰竭再住院率、PAF再发率及发作次数，降低NT-proBNP水平，逆转心肌重构，且安全性良好。

Abstract:
Objective To explore the efficacy and safety of dapagliflozin in patients with paroxysmal atrial fibrillation (PAF) combined with heart failure with preserved ejection fraction (HFpEF).
Methods A total of 120 patients with PAF combined with HFpEF treated at Jinshan Hospital of Fudan University from July 2022 to July 2023 were selected and randomly divided into the dapagliflozin group (n＝60, standard treatment combined with dapagliflozin) and the control group (n＝60, standard treatment combined with placebo). After 12 months of follow-up, the Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS), PAF duration, recurrence rate and frequency of PAF, left atrial diameter, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, left ventricular ejection fraction, P-wave dispersion, blood pressure, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), estimated glomerular filtration rate (eGFR), and glycated hemoglobin A_1C (HbA_1C) were compared between the two groups. Cardiovascular outcomes and adverse events were observed.
Results A total of 10 patients lost to follow-up, and 110 patients were included in the analysis (55 in each group). After 12 months of treatment, the KCCQ-TSS in the dapagliflozin group was significantly higher than that in the control group (61.68±2.65 points vs 44.98±4.76 points, P＜0.001). The PAF duration in the dapagliflozin group was significantly shorter than that in the control group (144±18 min vs 270±24 min, P＝0.045). After treatment, frequency of PAF, NT-proBNP levels, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, left atrial diameter, P-wave dispersion, and HbA_1C levels showed statistical differences between the two groups (P＜0.05). The heart failure readmission rate and PAF recurrence rate in the dapagliflozin group were significantly lower than those in the control group (P＜0.05). There was no significant difference in the incidence of adverse events between the two groups during treatment.
Conclusions Dapagliflozin improves patients’ quality of life, reduces PAF duration and recurrence rate, decreases heart failure readmission rate, lowers NT-proBNP levels, reverses cardiac remodeling, and demonstrates favorable safety in patients with PAF combined with HFpEF.

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