维立西呱联合四联疗法对心肌梗死后射血分数降低型心力衰竭患者的临床研究OA
Clinical trial of vericiguat combined with quadruple therapy in patients with heart failure with reduced ejection fraction after myocardial infarction
目的 观察维立西呱片联合四联疗法对心肌梗死后射血分数减低型心力衰竭(HFrEF)患者的临床疗效和安全性.方法 将入组的HFrEF患者根据用药方法分为对照组和试验组.对照组给予标准新四联疗法:沙库巴曲缬沙坦片每次50 mg,bid,逐步增量至目标每天150 mg·d-1;美托洛尔缓释片起始23.75 mg·d-1,每 2 周增量至最大 190 mg·d-1;螺内酯片 10~40 mg·d-1;达格列净片每次10 mg,qd.试验组在对照组基础上加用维立西呱片,起始2.5 mg·d-1,每2周滴定至最大10 mg·d-1;2组均连续治疗6个月.比较2组的心功能指标、心肌纤维化指标[转化生长因子-β1(TGF-β1)、结缔组织生长因子(CTGF)、可溶性生长刺激表达因子2(sST2)]、心肌损伤指标[嗜铬粒蛋白A(CgA)、N末端B型脑利钠肽前体(NT-proBNP)、缺氧诱导因子-1α(HIF-1α)]、明尼苏达州心功能不全生命质量量表(MLHFQ)评分、主要不良心血管事件(MACE)和临床疗效,并进行安全性评价.结果 共入组125例,对照组纳入63例,试验组纳入62例.治疗6个月后,对照组和试验组的临床总有效率分别为77.78%(49例/63例)和91.94%(57例/62例),左心室射血分数(LVEF)分别为(41.37±4.67)%和(45.18±4.85)%,心排血量(CO)分别为(4.31±0.60)和(4.69±0.52)L·min-1,左心室收缩末期容积(LVESV)分别为(51.28±5.57)和(44.86±4.90)mL,左心室舒张末期内径(LVEDD)分别为(56.42±6.35)和(52.87±5.84)mm,TGF-β1 分别为(49.15±5.27)和(43.48±5.64)ng·L-1,CTGF 分别为(70.68±7.68)和(61.54±6.59)μg·L-1,sST2 分别为(24.83±3.78)和(21.69±2.57)μg·L-1,CgA 分别为(240.48±25.43)和(182.33±21.58)mg·L-1,NT-proBNP 分别为(874.31±95.64)和(780.26±82.17)pg·mL-1,HIF-1α 分别为(12.16±1.58)和(9.25±1.17)ng·L-1,MLHFQ身体领域评分分别为(8.16±0.85)和(7.34±0.92)分,情绪领域评分分别为(5.71±0.73)和(4.15±0.60)分,其他领域评分分别为(10.44±1.78)和(8.16±1.39)分,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05,P<0.01).对照组和试验组的MACE总发生率分别为15.87%(10例/63例)和4.84%(3例/62例),在统计学上差异有统计学意义(P<0.05);对照组和试验组的药物不良反应总发生率分别为7.94%(5例/63例)和16.13%(10例/62例),在统计学上差异无统计学意义(P>0.05).结论 维立西呱片联合四联疗法可有效改善心肌梗死后HFrEF患者的心功能,减轻心肌纤维化,降低心肌损伤水平,同时提升患者生活质量.
Objective To observe the clinical efficacy and safety of vericiguat tablets combined with quadruple therapy in patients with heart failure with reduced ejection fraction(HFrEF)after myocardial infarction.Methods Patients with HFrEF after myocardial infarction were divided into control group and treatment group by drug treatment method.The control group was given standard new quadruple therapy:sacubitril/valsartan tablets 50 mg each time,twice a day,gradually increased to 150 mg·d-1;sustained-release metoprolol tablets 23.75 mg·d-1 initially,increased every 2 weeks to 190 mg·d-1;spironolactone tablets 10-40 mg·d-1;dapagliflozin tablets 10 mg each time,once a day.On the basis of the quadruple therapy in the control group,the treatment group was additionally given vericiguat tablets at an initial dose of 2.5 mg·d-1,which was titrated to the maximum dose of 10 mg·d-1 every 2 weeks.Both groups received continuous treatment for 6 months.The main observation indicators included cardiac function indicators,myocardial fibrosis indicators[transforming growth factor-β1(TGF-β1),connective tissue growth factor(CTGF),soluble suppression of tumorigenicity 2(sST2)],myocardial injury indicators[chromogranin A(CgA),N-terminal pro-B-type natriuretic peptide(NT-proBNP),hypoxia-inducible factor-1α(HIF-1α)],Minnesota living with heart failure questionnaire(MLHFQ)score,total clinical effective rate,adverse drug reactions,and major adverse cardiovascular events(MACE)were compared between the two groups,and the safety was conducted.Results A total of 125 patients were enrolled in the study.63 patients were included in control group and 62 patients in treatment group.After 6 months of treatment,the total clinical effective rate was 77.78%(49 cases/63 cases)in control group and 91.94%(57 cases/62 cases)in treatment group;the left ventricular ejection fraction(LVEF)was(41.37±4.67)% and(45.18±4.85)%,respectively;the cardiac output(CO)was(4.31±0.60)and(4.69±0.52)L·min-1,respectively;the left ventricular end-systolic volume(LVESV)was(51.28±5.57)and(44.86±4.90)mL,respectively;the left ventricular end-diastolic diameter(LVEDD)was(56.42±6.35)and(52.87±5.84)mm,respectively;the TGF-β1 levels were(49.15±5.27)and(43.48±5.64)ng·L-1,respectively;the CTGF levels were(70.68±7.68)and(61.54±6.59)μg·L-1,respectively;the sST2 levels were(24.83±3.78)and(21.69±2.57)μg·L-1,respectively;the CgA levels were(240.48±25.43)and(182.33±21.58)mg·L-1,respectively;the NT-proBNP levels were(874.31±95.64)and(780.26±82.17)pg·mL-1,respectively;the HIF-1α levels were(12.16±1.58)and(9.25±1.17)ng·L-1,respectively;the MLHFQ physical domain scores were(8.16±0.85)and(7.34±0.92)points,respectively;the emotional domain scores were(5.71±0.73)and(4.15±0.60)points,respectively;the other domain scores were(10.44±1.78)and(8.16±1.39)points,respectively.All intergroup differences of the above indicators were statistically significant(P<0.05,P<0.01).The total incidence of MACE was 15.87%(10 cases/63 cases)in control group and 4.84%(3 cases/62 cases)in treatment group,and the difference between the two groups was statistically significant(P<0.05).There was no significant difference in the total incidence of adverse drug reactions between control group(7.94%)and the treatment group(16.13%)(P>0.05).Conclusion The combination of vericiguat tablets and quadruple therapy can effectively improve cardiac function,reduce myocardial fibrosis,attenuate myocardial injury,and improve the quality of life in patients with HFrEF after myocardial infarction.
郭佳敏;赵灿;赵晓菲
邢台市中心医院心内四科 河北 邢台 054000保定市第一中心医院心血管内五科 河北保定 071051河北省第一荣军优抚医院心内科,河北邢台 054000
医药卫生
维立西呱片射血分数减低型心力衰竭心肌梗死心肌纤维化嗜铬粒蛋白A
vericiguat tabletheart failure with reduced ejection fractionmyocardial infarctionmyocardial fibrosischromogranin A
《中国临床药理学杂志》 2026 (13)
1837-1842,6
河北省卫生健康委医学科学研究课题计划基金资助项目(20251440)
评论