维立西呱联合沙库巴曲缬沙坦治疗慢性心力衰竭患者的临床研究OA
Clinical trial of the therapeutic effect of vericiguat combined with sacubitril valsartan in the treatment of patients with chronic heart failure
目的 探讨维立西呱片联合沙库巴曲缬沙坦钠片对慢性心力衰竭(CHF)干预的临床疗效和安全性.方法 将CHF患者根据不同治疗方案分为对照组和试验组.对照组口服沙库巴曲缬沙坦钠片,每次100 mg,每天2次,治疗3个月.试验组在对照组基础上加用维立西呱片治疗,初始服药剂量为每次2.5 mg,每天1次,2周后逐渐增加,最大剂量≤10 mg·d-1,治疗3个月.比较2组心功能、心肌能量代谢、血流动力学、血清学指标、总有效率,并进行安全性评价.结果 共入组104例,试验组52例、对照组52例.试验组无脱落病例,对照组因依从性差脱落2例,最终试验组和对照组各纳入52例和50例.试验组与对照组总有效率分别为94.23%(49例/52例)和80.00%(40例/50例),在统计学上差异有统计学意义(P<0.05).治疗后,试验组和对照组左室舒张末期内径(LVEDD)分别为(47.42±4.98)和(51.25±5.86)mm,每搏输出量(SV)分别为(68.82±7.37)和(63.97±6.74)mL,左心室射血分数(LVEF)分别为(56.88±5.96)%和(53.35±5.53)%,心肌能量消耗(MEE)分别为(101.68±11.72)和(108.69±12.95)cal·min-1,游离脂肪酸(FFA)分别为(652.11±67.64)和(692.03±70.85)μmol·L-1,心排血量(CO)分别为(5.16±0.75)和(4.69±0.63)L.min-1,心排血指数(CI)分别为(2.82±0.45)和(2.53±0.38)L·min-1·m-2,成纤维细胞生长因子23(FGF23)分别为(29.38±3.43)和(32.04±4.67)ng·mL-1,N末端 B 型脑钠肽前体(NT-proBNP)分别为(363.24±39.86)和(390.06±43.31)pg·mL-1,转录因子叉框蛋白O1(FOXO1)分别为(2.43±0.37)和(2.72±0.45)ng·mL-1,上述指标试验组与对照组比较,在统计学上差异均有统计学意义(均P<0.05).试验组与对照组药物不良反应总发生率分别为13.46%(7例/52例)和8.00%(4例/50例),在统计学上差异无统计学意义(P>0.05).结论 CHF患者采用维立西呱片联合沙库巴曲缬沙坦钠片联合方案干预,可有效降低心肌组织损伤,调节血流动力学水平,促进心肌能量代谢恢复,防止心室重构,整体心功能保护效果较为理想.
Objective To explore the clinical efficacy and safety of vericiguat tablets(VER)combined with sacubitril valsartan sodium tablets on chronic heart failure(CHF).Methods CHF patients were divided into the control group and the treatment group based on different treatment regimens.The control group was administered sacubitril valsartan sodium tablets orally,100 mg each time,twice a day,for 3 months.The treatment group received additional vericiguat tablets treatment on basis of control group.The initial dose was 2.5 mg each time,once a day.After two weeks,the dose was gradually increased up to a maximum of 10 mg per day,for a total of 3 months of treatment.The cardiac function,myocardial energy metabolism,hemodynamics,serological indicators,total effective rate and safety were compared.Results A total of 104 cases were selected.There were 52 cases in the treatment group and 52 cases in the control group.There were no dropout cases in the treatment group.In the control group,2 cases dropped out due to poor compliance.In the end,52 cases were included in the treatment group and 50 cases in the control group.The total effective rates of the treatment group and the control group were 94.23%(49 cases/52 cases)and 80.00%(40 cases/50 cases)respectively;the difference was statistically significant(P<0.05).After treatment,the left ventricular end-diastolic diameter(LVEDD)in the treatment group and the control group were(47.42±4.98)and(51.25±5.86)mm,respectively;the stroke volume(SV)was(68.82±7.37)and(63.97±6.74)mL,respectively;the left ventricular ejection fraction(LVEF)were(56.88±5.96)%and(53.35±5.53)%,respectively;myocardial energy expenditure(MEE)were(101.68±11.72)and(108.69±12.95)cal·min-1,respectively;free fatty acids(FFA)were(652.11±67.64)and(692.03±70.85)μmol·L-1,respectively;the cardiac output(CO)were(5.16±0.75)and(4.69±0.63)L·min-1,respectively;the cardiac output index(CI)was(2.82±0.45)and(2.53±0.38)L·min-1·m-2,respectively;fibroblast growth factor 23(FGF23)were(29.38±3.43)and(32.04±4.67)ng·mL-1,respectively;N-terminal pro-brain natriuretic peptide(NT-proBNP)were(363.24±39.86)and(390.06±43.31)pg·mL-1,respectively;transcription factor fork box protein O1(FOXO1)were(2.43±0.37)and(2.72±0.45)ng·mL-1,respectively;Compared between the treatment group and the control group,the differences of above indicators were all astatistically significant difference(all P<0.05).The total incidence of adverse drug reactions in the treatment group and the control group was 13.46%(7 cases/52 cases)and 8.00%(4 cases/50 cases),with no statistically significant difference(P>0.05).Conclusion The combination of vericiguat tablets and sacubitril valsartan sodium tablets for CHF patients can effectively reduce myocardial tissue damage,regulate hemodynamic levels,promote the recovery of myocardial energy metabolism,prevent ventricular remodeling,and with relatively ideal overall protective effect on cardiac function.
何卓群;刘丹丹;寇丹;张虹;张会芳
保定市第一中心医院急诊一科,河北保定 071000邯郸市第一医院全科医疗科,河北邯郸 056000保定市第一中心医院心血管内一科,河北保定 071000邢台市中心医院心内科,河北邢台 054000保定市第一中心医院急诊一科,河北保定 071000
医药卫生
维立西呱片沙库巴曲缬沙坦钠片慢性心力衰竭心功能血流动力学
vericiguat tabletssacubitril valsartan sodium tabletschronic heart failurecardiac functionhemodynamics
《中国临床药理学杂志》 2026 (16)
2258-2263,6
河北省2026年度医学科学研究课题计划(20261390)
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