Prognostic of dapagliflozin in patients with ejection fraction preserving heart failure combined with paroxysmal atrial fibrillation
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摘要: 目的 探讨达格列净治疗射血分数保留型心力衰竭(HFpEF)合并阵发性心房颤动(PAF)的临床疗效。方法 选取2023年1月-2023年4月安徽省第二人民医院200例HFpEF合并PAF患者, 采用随机数字表法将患者分为试验组和对照组各100例。对照组予常规药物治疗, 试验组予常规药物联合达格列净治疗。观察两组治疗前及治疗后3、6、9个月心房颤动(房颤)每月发作次数、每次房颤最长持续时间、血浆N末端B型利钠肽前体(NT-proBNP)、白细胞介素-6(IL-6)、左心室质量分数(LVMI)、左心房容积指数(LAVI)、24 h平均心室率、QTc间期等指标, 以及治疗期间不良反应、治疗9个月后因心力衰竭再住院情况。结果 对照组和试验组治疗后3、6、9个月房颤每月发作次数、每次房颤最长持续时间、NT-proBNP、IL-6、LVMI、LAVI、24 h平均心室率、QTc间期均显著改善, 且改善程度随着治疗时间的延长而增强, 同时试验组改善幅度较对照组显著(均P < 0.05)。治疗9个月后, 试验组心力衰竭再住院率低于对照组(38% vs 25%, χ2=3.916, P=0.048)。治疗期间, 两组不良反应发生率差异无统计学意义(9% vs 7%, χ2=0.270, P=0.603)。结论 达格列净可改善HFpEF合并PAF患者心脏功能, 缓解心房及心室重构, 提高远期预后, 具有良好的安全性。
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关键词:
- 达格列净 /
- 射血分数保留型心力衰竭 /
- 阵发性心房颤动 /
- 心脏功能
Abstract: Objective To investigate the clinical efficacy of dapagliflozin in the treatment of ejection fraction preserving heart failure (HFpEF) combined with paroxysmal atrial fibrillation (PAF).Methods Two-hundred patients with HFpEF combined with PAF in Anhui No.2 Provincial People's Hospital from January 2023 to April 2023 were selected, and the patients were divided into the experimental group and the control group with 100 cases each by random number table method.Patients in the control group were treated with conventional drugs, and those in the experimental group were treated with conventional drugs combined with dapagliflozin.The monthly occurrence of atrial fibrillation and the longest duration of each atrial fibrillation, plasma N-terminal B-type natriuretic peptide precursor (NT-proBNP), interleukin-6(IL-6), left ventricular mass fraction (LVMI), left atrial volume index (LAVI), 24-hour average ventricular rate, and QTc interval before treatment and 3, 6 and 9 months after treatment, as well as adverse reactions during treatment, and re-hospitalization for heart failure after 9 months of treatment were observed.Results After 3, 6, and 9 months of treatment, the monthly occurrence of atrial fibrillation, the longest duration of each atrial fibrillation, NT-proBNP, IL-6, LVMI, LAVI, 24-hour mean ventricular rate, and QTc interval were significantly improved in both the control and experimental groups, and the degree of improvement increased with the prolongation of treatment time.At the same time, the improvement in the experimental group was significantly higher than that in the control group (all P < 0.05).After 9 months of treatment, the re-admission rate of heart failure in the experimental group was lower than that in the control group (38% vs 25%, χ2=3.916, P=0.048).During the treatment period, there was no statistically significant difference in the incidence of adverse reactions between the two groups (9% vs 7%, χ2=0.270, P=0.603).Conclusion Dapagliflozin can improve cardiac function, alleviate atrial and ventricular remodeling, improve long-term prognosis and has good safety in HFpEF patients with PAF. -
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表 1 对照组与试验组基线资料比较
Table 1. Baseline data
例(%), X±S 指标 对照组
(100例)试验组
(100例)P 男/女/例 56/44 52/48 0.430 年龄/岁 59.01±6.10 57.45±9.60 0.269 BMI/(kg/m2) 24.92±3.14 25.94±3.24 0.056 左心房内径/mm 47.02±8.53 47.73±9.48 0.579 基础疾病 糖尿病 8(8.00) 9(9.00) 0.800 血脂异常 22(22.00) 24(24.00) 0.738 高血压 18(18.00) 20(20.00) 0.719 抗凝药物使用 华法林 5(5.00) 6(6.00) 0.757 利伐沙班 14(14.00) 13(13.00) 0.837 达比加群酯 10(10.00) 11(11.00) 0.818 
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表 2 对照组与试验组房颤发作情况比较
Table 2. Atrial fibrillation data
X±S 指标 对照组(100例) 试验组(100例) 房颤每月发作/次 治疗前 9.67±1.12 9.86±1.15 治疗3个月 7.43±0.761) 5.95±0.621)4) 治疗6个月 5.64±0.591)2) 2.28±0.261)2)4) 治疗9个月 2.54±0.281)2)3) 0.85±0.071)2)3)4) 每次房颤最长持续时间/(h/次) 治疗前 2.54±0.28 2.56±0.30 治疗3个月 2.29±0.251) 2.11±0.231)4) 治疗6个月 1.75±0.191)2) 1.01±0.131)2)4) 治疗9个月 1.37±0.151)2)3) 0.68±0.081)2)3)4) 与同组治疗前比较，1)P < 0.05；与同组治疗3个月比较，2)P < 0.05；与同组治疗6个月比较，3)P < 0.05；与对照组同期比较，4)P < 0.05。
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表 3 对照组与试验组NT-proBNP和IL-6水平比较
Table 3. NT-proBNP and IL-6 levels
pg/mL, X±S 指标 对照组(100例) 试验组(100例) NT-proBNP 治疗前 1 724.88±310.91 1 640.49±389.04 治疗3个月 1 234.33±280.401) 1 033.08±226.601)4) 治疗6个月 935.50±289.541)2) 880.93±262.171)2)4) 治疗9个月 648.10±299.701)2)3) 503.97±246.571)2)3)4) IL-6 治疗前 24.92±3.14 25.94±3.24 治疗3个月 18.56±2.321) 17.60±2.141)4) 治疗6个月 14.52±1.761)2) 10.02±1.401)2)4) 治疗9个月 12.60±1.571)2)3) 6.24±0.741)2)3)4) 与同组治疗前比较，1)P < 0.05；与同组治疗3个月比较，2)P < 0.05；与同组治疗6个月比较，3)P < 0.05；与对照组同期比较，4)P < 0.05。
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表 4 对照组与试验组LVMI和LAVI水平比较
Table 4. LVMI and LAVI levels
X±S 指标 对照组(100例) 试验组(100例) LVMI/(g/m2) 治疗前 99.47±10.10 101.870±9.50 治疗3个月 100.10±9.57 93.99±10.121)4) 治疗6个月 95.94±9.541)2) 91.51±10.111)2)4) 治疗9个月 93.51±9.551)2)3) 90.01±10.101)2)3)4) LAVI/(mL/m2) 治疗前 50.06±4.12 50.07±5.03 治疗3个月 44.06±4.201) 39.09±4.091)4) 治疗6个月 37.06±4.271)2) 34.06±5.071)2)4) 治疗9个月 32.00±4.371)2)3) 23.01±5.171)2)3)4) 与同组治疗前比较，1)P < 0.05；与同组治疗3个月比较，2)P < 0.05；与同组治疗6个月比较，3)P < 0.05；与对照组同期比较，4)P < 0.05。
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表 5 对照组与试验组24 h平均心室率和QTc间期水平比较
Table 5. 24-hour average ventricular rate and QTc interval
X±S 指标 对照组(100例) 试验组(100例) 24 h平均心室率/(次/min) 治疗前 89.83±10.85 91.54.±10.53 治疗3个月 86.98±11.211) 80.57±10.821)4) 治疗6个月 80.62±11.061)2) 77.98±10.851)2)4) 治疗9个月 71.92±10.851)2)3) 67.80±11.101)2)3)4) QTc间期/ms 治疗前 540.56±56.94 545.83±56.97 治疗3个月 512.63±55.081) 482.82±50.261)4) 治疗6个月 488.25±52.061)2) 451.64±48.191)2)4) 治疗9个月 462.06±49.111)2)3) 434.20±46.391)2)3)4) 与同组治疗前比较，1)P < 0.05；与同组治疗3个月比较，2)P < 0.05；与同组治疗6个月比较，3)P < 0.05；与对照组同期比较，4)P < 0.05。
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表 6 对照组与试验组不良反应比较
Table 6. Adverse reactions
例(%) 项目 对照组
(100例)试验组
(100例)χ2 P 低血糖 1(1.00) 1(1.00) 尿路感染 2(2.00) 0 低血压 2(2.00) 2(2.00) 肝功能异常 2(2.00) 2(2.00) 肾功能异常 2(2.00) 2(2.00) 合计 9(9.00) 7(7.00) 0.270 0.603
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