恩格列净与利格列汀治疗2型糖尿病合并心力衰竭患者的临床研究

Clinical trial of empagliflozin and linagliptin in the treatment of patients with type 2diabetes mellitus with heart failure

目的 比较恩格列净和利格列汀治疗2型糖尿病(T2DM)合并心力衰竭(HF)患者的疗效及安全性。方法 随机将T2DM合并HF患者分为对照组和试验组。2组患者均予以个体化抗HF及二甲双胍基础降糖治疗,此外,对照组口服利格列汀,每次5 mg,qd;试验组口服恩格列净,每次10 mg,qd。2组患者均连续治疗6个月。比较2组的临床疗效,治疗前后血糖指标[空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、糖化血红蛋白(HbA1c)]、心脏分子标志物[N末端脑钠肽前体(NT-proBNP)、成纤维细胞生长因子(FGF23)、和肽素(CPP)]、心功能指标[左心室舒张末内径(LVEDD)、左心室射血分数(LVEF)、左心室重构指数(LVRI)],记录药物不良反应发生情况。结果 试验组和对照组各入组40例。治疗后,试验组和对照组总有效率对应为97.50%(39例/40例)和80.00%(32例/40例),在统计学上差异有统计学意义(P<0.05)。试验组和对照组FBG分别为(7.64±1.18)和(7.83±1.24)mmol·L^(-1),2 h PBG分别为(8.97±1.46)和(9.04±1.35)mmol·L^(-1),HbA1c分别为(7.58±1.27)%和(7.65±1.42)%,在统计学上差异均无统计学意义(均P>0.05)。试验组和对照组NT-proBNP分别为(612.53±204.62)和(1 045.24±316.75)pg·mL^(-1),FGF23分别为(362.74±62.61)和(493.27±74.64)μg·L^(-1),CPP分别为(12.58±3.43)和(16.87±4.36)pmol·L^(-1),LVEDD分别为(51.19±2.36)和(53.35±2.24)mm, LVEF分别为(52.69±3.38)%和(50.28±3.75)%,LVRI对应为(2.62±0.29)和(2.96±0.33)kg·L^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组药物不良反应发生率分别为5.00%(2例/40例)和10.00%(4例/40例),在统计学上差异无统计学意义(P>0.05)。结论 恩格列净和利格列汀均可有效降低T2DM合并HF患者血糖,其中恩格列净能更好促进患者心功能改善,且不明显增加药物不良反应发生率。

Objective To compare the efficacy and safety of empagliflozin and linagliptin in the treatment of patients with type 2 diabetes mellitus(T2DM)with heart failure(HF).Methods Patients with T2DM and HF were randomly into control group and treatment group.Both groups were treated with individualized anti-HF and metformin-based hypoglycemic therapy.On this basis,the control group was given linagliptin orally(5 mg each time,once a day),while the treatment group was given oral administration of empagliflozin 10 mg every day.Patients in both groups were treated continuously for 6 months.The clinical efficacy and blood glucose indicators[fasting blood glucose(FBG),2 h postprandial blood glucose(2 h PBG),hemoglobin A1c(HbA1c)],cardiac molecular markers[N-terminal pro-brain natriuretic peptide(NT-proBNP),fibroblast growth factor 23(FGF23),copeptin(CPP)]and caridac function indicators[left ventricular end-diastolic diameter(LVEDD),left ventricular ejection fraction(LVEF),left ventricular remodeling index(LVRI)]before and after treatment were compared,and the adverse drug reactions were recorded.Results There were 40 cases in treatment group and 40 cases in control group.After treatment,the total effective rates in treatment group and control group were 97.50%(39 cases/40 cases)and 80.00%(32 cases/40 cases),with no significant difference(P<0.05).The FBG levels in treatment group and control group were(7.64±1.18)and(7.83±1.24)mmol·L^(-1);2 h PBG levels were(8.97±1.46)and(9.04±1.35)mmol·L^(-1);HbA1c levels were(7.58±1.27)%and(7.65±1.42)%,all with no significant difference(all P>0.05).The NT-proBNP levels in treatment group and control group were(612.53±204.62)and(1045.24±316.75)pg·mL^(-1);FGF23 levels were(362.74±62.61)and(493.27±74.64)μg·L^(-1);CPP levels were(12.58±3.43)and(16.87±4.36)pmol·L^(-1);LVEDD values were(51.19±2.36)and(53.35±2.24)mm;LVEF values were(52.69±3.38)%and(50.28±3.75)%;LVRI values were(2.62±0.29)and(2.96±0.33)kg·L^(-1),all with significant difference(all P<0.05).The incidence rates of adverse reactions in treatment group and control group were 5.00%(2 cases/40 cases)and 10.00%(4 cases/40 cases),with no significant difference(P>0.05).Conclusion Both empagliflozin and linagliptin can effectively reduce the blood glucose in patients with T2 DM complicated with HF.Empagliflozin can better promote the improvement of cardiac function in patients without significantly increase the incidence of adverse drug reactions.