钠-葡萄糖协同转运蛋白抑制剂对合并射血分数保留型心力衰竭的2型糖尿病患者的心血管保护作用研究

A study of sodium-glucose co-transporter inhibitor in improving the prognosis of type 2 diabetes with heart failure with preserved ejection fraction patients

目的:探讨达格列净对伴有射血分数保留型心力衰竭(HFpEF)的2型糖尿病(T2D)患者的心血管危险因素、症状及短期预后是否有改善作用。方法:采用前瞻性随机对照研究,入组2018年11月—2019年11月在哈尔滨医科大学附属第一医院住院治疗的HFpEF(非急性发作期)合并T2D患者,将患者随机分为试验组(100例)和对照组(100例),患者均给予常规降糖治疗和常规心力衰竭(HF)治疗,试验组在普通降糖药物治疗的基础上加用达格列净片[钠-葡萄糖协同转运蛋白2抑制剂(SGLT-2i)10 mg,1次/d晨服,调整药物用量至血糖降至理想水平,两组维持治疗方案治疗至少6个月。观察两组患者治疗前后血压、血脂、心率、NT-proBNP、血钠水平,随访观察6个月记录两组患者主要终点事件(心血管死亡和HF再住院)、次要终点事件(心绞痛和心肌梗死)及全因死亡率。结果:两组患者在基础数据方面差异无统计学意义。随访6个月后,与对照组比较,试验组血压(P_(50):132/80 mmHg∶P_(50):145/93 mmHg,1 mmHg=0.133 kPa,P<0.05)、低密度脂蛋白胆固醇(LDL)[(2.45±0.77)mmol/L∶(2.76±0.85)mmol/L,P<0.05]、心率[(78.49±19.35)次/min∶(83.83±18.21)次/min,P<0.05]水平降低,NT-proBNP[678(339,1017)pg/mL∶866(433,1299)pg/mL,P<0.05]和血钠[(135.91±4.22)mmol/L:(138.41±4.74)mmol/L,P<0.05]浓度下降,试验组主要终点事件发生率明显低于对照组(7.0%∶16.0%,P<0.05),试验组次要终点事件发生率较对照组有下降趋势,但差异无统计学意义(3.0%∶9.0%,P>0.05),两组间全因死亡率差异无统计学意义(3.0%∶4.0%,P>0.05)。结论:达格列净对合并HFpEF的T2D患者具有心血管保护作用。

Objective:To observe whether dapagliflozin can improve the cardiovascular risk factors and short-term prognosis in patients with type 2 diabetes(T2 D)accompanied by heart failure with preserved ejection fraction(HFpEF).Methods:This research is a prospective randomized controlled study.Two hundred patients diagnosed T2 D accompanied by HFpEF were collected in Harbin medical university from November 2018 to November 2019.The patients was randomly divided into test group and control group.Each group contained 100 patients.Both of them was treated by standard therapy of heart failure and diabetes.Additionally,dapagliflozin(AstraZeneca pharmaceutical company)was added to the test group 10 mg once a day and we simultaneously adjusted the drug dosages until the patients’blood glucose is normal.We compared the blood pressure,serum lipid,heart rate,NT-proBNP,serum sodium level,the rate of cardiovascular adverse events,and heart failure re-hospitalization.Results:There was no significant different of basic characteristics between two groups(P>0.05).After six months treatment,the test group had lower blood pressure(P_(50):132/80 mmHg:P_(50):145/93 mmHg,1 mmHg=0.133 kPa,P<0.05),LDL[(2.45±0.77)mmol/L∶(2.76±0.85)mmol/L,P<0.05],heart rate[(78.49±19.35)beats/min∶(83.83±18.21)beats/min,P<0.05],NT-proBNP[678(339,1017)pg/mL∶866(433,1299)pg/mL,P<0.05],and serum sodium level[(135.91±4.22)mmol/L∶(138.41±4.74)mmol/L,P<0.05]compared with the control group.The incidence of primary endpoint events in the test group was significantly lower than that in the control group(7.0%∶16.0%,P<0.05),The incidence of secondary end-point events in the test group was lower than that in the control group,but the difference was not statistically significant(3.0%∶9.0%,P>0.05).The difference in all-cause mortality between the two groups was not statistically significant(3.0%∶4.0%,P>0.05),which may be related to the small sample size and short observation time.Conclusion:Dapagliflozin can improve the cardiovascular risk factors,symptom and short-term prognosis in T2 D patients accompanied by HFpEF.