To Investigate the Application Effect of Dapagliflozin in Elderly Patients with HFpEF and Type 2 Diabetes Mellitus and Its Effect on Inflammatory Factors
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摘要:
目的 探讨达格列净在老年射血分数保留心力衰竭（HFpEF）合并2型糖尿病患者中的应用效果及对炎性因子的影响。 方法 随机选取2021年3月至2022年9月昆明市第二人民医院老年HFpEF合并2型糖尿病患者64例，采用随机抽签法均分为2组，对照组应用二甲双胍治疗，研究组应用达格列净治疗。记录2组心脏超声相关指标及运动耐力变化、炎性因子、N端脑钠肽前体水平变化、不良反应情况。 结果 2组治疗3个月、半年时LVEF、6 min步行距离指标均大于治疗前，LVEDD、E/e′指标均小于治疗前，差异有统计学意义（P < 0.05）；研究组治疗3个月、半年时LVEF、6 min步行距离指标均大于对照组， LVEDD、E/e′指标均小于对照组，差异有统计学意义（P < 0.05）；2组治疗3个月、半年时hs-CRP、TNF-α、NT-proBNP指标均小于治疗前，差异有统计学意义（P < 0.05）；研究组治疗3个月、半年时hs-CRP、TNF-α、NT-proBNP指标均小于对照组，差异有统计学意义（P < 0.05）；2组治疗过程中均无发生过敏性皮疹、低血压、急性肾功能损伤、高钾血症不良反应，在胃肠道反应、泌尿系统感染、低血糖不良反应发生率对比显示，差异无统计学意义（P > 0.05）。 结论 达格列净治疗老年HFpEF合并2型糖尿病患者，相较于应用二甲双胍降糖药物，可以进一步改善患者心功能，提升运动耐力，且未明显增加不良反应，安全性较高。 -
关键词:
- 2型糖尿病 /
- 射血分数保留心力衰竭 /
- 运动耐力 /
- 左室射血分数
Abstract:Objective To investigate the efficacy of dapagliflozin in elderly heart failure patients with preserved ejection fraction （HFpEF） complicated with type 2 diabetes mellitus （T2DM） and its effect on inflammatory factors. Methods From March 2021 to September 2022, 64 patients with HFpEF and type 2 diabetes in the Second People’s Hospital of Kunming were randomly divided into two groups. The control group was treated with metformin, and the study group was treated with dapagliflozin. The indexes of cardiac ultrasound, changes in exercise endurance, inflammatory factors, N-terminal pro-brain natriuretic peptide levels, and adverse reactions were studied. Results After 3 months and 6 months of treatment, the LVEF and 6 min walking distance indexes of the two groups were significantly higher than those before treatment （P < 0.05）, and the LVEDD and E/e′ indexes were significantly lower than those before treatment （P < 0.05）. After 3 months and 6 months of treatment, LVEF and 6 min walking distance indexes of the study group were significantly higher than those of the control group （P < 0.05）, LVEDD and E/e′ indexes were significantly lower than those of the control group, and the differences were statistically significant （P < 0.05）. The hs-CRP, TNF-α and NT-proBNP of the two groups at 3 months and 6 months after treatment significantly were lower than those before treatment （P < 0.05）. The hs-CRP, TNF-α and NT-proBNP in the study group were significantly lower than those in the control group at 3 months and 6 months after treatment （P < 0.05）. There were no adverse reactions such as allergic rash, hypotension, acute renal injury, and hyperkalemia in two groups during treatment, and there were no statistically significant differences in the incidence of adverse reactions such as gastrointestinal reaction, urinary system infection, and hypoglycemia between the two groups （P > 0.05）. Conclusion In the treatment of elderly HFpEF patients with type 2 diabetes mellitus, compared with metformin dapagliflozin can improve cardiac function and exercise endurance , without significant adverse reactions. -
表 1 2组患者一般资料比较（
$ \bar x \pm s$ ）Table 1. Comparison of general data between the two groups （
$ \bar x \pm s$ ）组别 n 性别（n） 平均年龄（岁） 入院收缩压（mmHg） 糖尿病病程（a） 体重指数（kg/m2） HYNA心功能分级 男/女 Ⅱ级/Ⅲ级/Ⅳ级 对照组 32 18/14 74.6 ± 19.1 128.4 ± 7.7 5.88 ± 1.19 23.0 ± 1.2 10/16/6 研究组 32 19/13 74.8 ± 19.0 128.7 ± 8.8 5.87 ± 1.18 22.8 ± 1.1 9/17/6 χ2/t − 0.064 0.042 0.145 0.034 0.695 0.075 P − 0.800 0.967 0.885 0.973 0.490 0.784 
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表 2 2组治疗前、治疗3个月及治疗半年LVEF、LVEDD指标情况比较（
$ \bar x \pm s$ ）Table 2. The LVEF and LVEDD indexes of the two groups before treatment，3 months and 6 months after treatment were compared （
$ \bar x \pm s$ ）组别 n LVEF（%） LVEDD（mm） 治疗前 治疗3个月 治疗半年 治疗前 治疗3个月 治疗半年 对照组 32 41.2 ± 2.0 53.5 ± 1.8 54.4 ± 2.4 63.4 ± 5.0 58.4 ± 2.0 57.1 ± 1.0 研究组 32 41.9 ± 1.9 63.8 ± 3.5 64.9 ± 4.5 63.5 ± 5.1 54.2 ± 2.9 51.0 ± 1.9 t − 1.435 14.804 11.646 0.079 6.744 16.071 P − 0.156 0.001*# 0.001*# 0.937 0.001*# 0.001*# 与治疗前比较，*P < 0.05；与对照组比较，#P < 0.05。
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表 3 2组治疗前、治疗3个月及治疗半年E/e′、6 min步行距离指标情况比较（
$ \bar x \pm s$ ）Table 3. Comparison of E/e′ and 6 min walking distance indexes between the two groups before treatment，3 months and 6 months of treatment （
$ \bar x \pm s$ ）组别 n E/e′ 6 min步行距离（m） 治疗前 治疗3个月 治疗半年 治疗前 治疗3个月 治疗半年 对照组 32 12.2 ± 2.7 10.0 ± 2.0 8.9 ± 1.7 302.3 ± 13.0 317.2 ± 14.0 387.1 ± 20.5 研究组 32 12.5 ± 2.8 8.1 ± 1.6 6.8 ± 1.2 306.7 ± 14.8 446.8 ± 18.7 472.6 ± 22.3 t − 0.436 4.196 5.709 1.264 31.384 15.967 P − 0.664 0.001*# 0.001*# 0.211 0.001*# 0.001*# 与治疗前比较，*P < 0.05；与对照组比较，#P < 0.05。
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表 4 2组炎性因子、N端脑钠肽前体水平变化情况对比（
$ \bar x \pm s$ ）Table 4. Comparison of changes in inflammatory factors and N-terminal pro-brain natriuretic peptide levels between the two groups （
$ \bar x \pm s$ ）组别 n hs-CRP（mg/L） TNF-α（ng/L） NT-proBNP（ng/L） 治疗前 治疗3个月 治疗半年 治疗前 治疗3个月 治疗半年 治疗前 治疗3个月 治疗半年 对照组 32 9.7 ± 1.1 7.3 ± 1.3 6.6 ± 0.9 82.6 ± 15.1 53.0 ± 10.5 40.9 ± 13.0 3084.6 ± 224.1 2166.4 ± 110.6 989.4 ± 28.8 研究组 32 9.9 ± 1.3 5.5 ± 1.2 4.7 ± 0.4 84.5 ± 13.1 34.5 ± 6.2 23.2 ± 1.6 3075.7 ± 219.8 1274.3 ± 119.4 622.6 ± 20.0 t − 0.664 5.755 10.913 0.538 8.582 7.644 0.160 31.007 59.177 P − 0.509 0.001*# 0.001*# 0.592 0.001*# 0.001*# 0.873 0.001*# 0.001*# 与治疗前比较，*P < 0.05；与对照组比较，#P < 0.05。
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表 5 2组不良反应情况对比（n）
Table 5. Comparison of adverse reactions between the two groups （n）
组别 n 胃肠道
反应泌尿系统
感染低血糖 发生率
[n（%）]对照组 32 2 1 1 4（12.5） 研究组 32 1 1 1 3（9.4） χ2 − − − − 0.156 P − − − − 0.692
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