恩格列净联合沙库巴曲缬沙坦治疗射血分数保留的心力衰竭患者的临床研究

Clinical trial of empagliflozin combined with sacubitril/valsartan in the treatment of patients with heart failure with preserved ejection fraction

目的观察恩格列净联合沙库巴曲缬沙坦治疗射血分数保留的心力衰竭(HF-PEF)的效果及其对超声心动图参数的影响。方法将HF-PEF患者分为试验组和对照组。对照组给予沙库巴曲缬沙坦,每次10 mg,每天3次,口服。试验组在对照组的基础上给予恩格列净,每次10 mg,每天3次,口服;2组均持续治疗10周。比较2组治疗前后6 min步行距离(6MWD)、明尼苏达心力衰竭生活质量问卷(MLHFQ)评分、血浆N末端脑钠肽前体水平(NT-proBNP)水平、左心室舒张末期容积(LVESD)、左心室射血分数(LVEF)、左心室收缩末期容积(LVEDD)、舒张早期二尖瓣血流速度/舒张晚期二尖瓣血流速度(E/A)、肿瘤坏死因子-α(TNF-α)、超敏C反应蛋白(hs-CRP)、白细胞介素-6(IL-6)水平、安全性和随访期间主要心脏不良事件(MACE)发生情况。结果试验组52例,对照组68例。治疗后,试验组和对照组的6MWD分别为(437.68±19.25)和(392.12±20.13)m;LVEF分别为(58.52±1.80)%和(56.06±1.75)%;E/A分别为1.27±0.26和1.04±0.35;NT-proBNP分别为(231.38±39.25)和(420.56±47.08)pg·mL^(-1);MLHFQ评分分别为(34.61±7.52)和(43.86±9.83)分;LVESD分别为(52.73±4.29)和(59.18±4.74)mm;LVEDD分别为(42.37±4.56)和(47.82±4.69)mm;hs-CRP分别为(10.19±2.31)和(15.33±2.96)mg·L^(-1);TNF-α分别为(14.82±2.36)和(17.56±2.55)ng·mL^(-1);IL-6分别为(7.11±0.58)和(10.85±1.39)pg·mL^(-1),差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应发生率分别为7.69%和10.29%;随访期间MACE发生率分别为9.62%和24.14%,差异有统计学意义(P<0.05)。结论恩格列净联合沙库巴曲缬沙坦钠可提高HF-PEF的治疗效果,改善超声心动图参数,安全性良好。

Objective To explore the clinical effect of empagliflozin combined with sacubitril/valsartan on heart failure with preserved ejection fraction(HF-PEF)and its influences on echocardiogram parameters.Methods HF-PEF patients were divided into treatment group and control group.Control group was treated with sacubitril/valsartan,10 mg once,3 times a day;treatment group was treated with empagliflozin 10 mg once,3 times a day on the basis of control group.All were treated for 10 weeks.The 6-minute walking distance(6MWD),score of Minnesota Heart Failure Quality of Life Questionnaire(MLHFQ),level of pla sma N-terminal pro-brain nitric peptide(NT-proBNP),left ventricular end-diastolic volume(LVESD),left ventricular ejection fraction(LVEF),left ventricular end-systolic volume(LVEDD),early diastolic mitral valve blood flow velocity/late diastolic peak flow velocity(E/A),tumor necrosis factor-α(TNF-α),hypersensitive C-reactive protein(hs-CRP)and interleukin-6(IL-6)before and after treatment,safety and the occurrence of major adverse cardiac events(MACE)during follow-up were compared between the two groups.Results There were 52 cases in treatment group and 68 cases in control group,respectively.After treatment,6MWD in treatment group and control group were(437.68±19.25)and(392.12±20.13)m;LVEF were(58.52±1.80)%and(56.06±1.75)%;E/A were 1.27±0.26 and 1.04±0.35;NT-proBNP levels were(231.38±39.25)and(420.56±47.08)pg·mL^(-1);MLHFQ scores were(34.61±7.52)and(43.86±9.83)points;LVESD were(52.73±4.29)and(59.18±4.74)mm;LVEDD were(42.37±4.56)and(47.82±4.69)mm;hs-CRP levels were(10.19±2.31)and(15.33±2.96)mg·L^(-1);TNF-αlevels were(14.82±2.36)and(17.56±2.55)ng·mL^(-1);IL-6 levels were(7.11±0.58)and(10.85±1.39)pg·mL^(-1),the differences were statistically significant(all P<0.05).The incidence of adverse drug reactions in treatment group and control group were 7.69%and 10.29%,respectively;during follow-up,the incidence of MACE in treatment group and control group were 9.62%and 24.14%,the difference was statistically significant(P<0.05).Conclusion Empagliflozin combined with sacubitril/valsartan sodium can improve curative effect and echocardiogram parameters in HF-PEF,with good safety.