维立西呱联合沙库巴曲缬沙坦钠治疗射血分数降低型心力衰竭患者的临床研究  

Clinical trail of vericiguat combined with sacubitrilvalsartan sodium in the treatment of patients with heart failure with reduced ejection fraction

作　　者：王妙君 徐时平[1] 潘小进[1] 叶志冬 练育芳[1] 邱珺 卢少堂 周晟劼 WANG Miao-jun;XU Shi-ping;PAN Xiao-jin;YE Zhi-dong;LIAN Yu-fang;QIU Jun;LU Shao-tang;ZHOU Sheng-jie(Departmentof Cardiology,Dongtai People's Hospital,Dongtai2i 24200,Jiangsu Province,China)

机构地区：[1]东台市人民医院心血管内科,江苏东台224200

出　　处：《中国临床药理学杂志》2025年第1期6-10,共5页The Chinese Journal of Clinical Pharmacology

基　　金：江苏省老年健康科研基金资助项目(LSD2022031);南通大学临床医学专项科研基金资助项目(2023LY014)。

摘　　要：目的观察维立西呱片联合沙库巴曲缬沙坦钠(Sac/Val)片治疗射血分数降低型心力衰竭(HFrEF)患者的临床疗效及安全性。方法将HFrEF患者按队列法分为对照组和试验组。对照组给予Sac/Val片,每次200mg,bid,口服;试验组在对照组治疗的基础上,给予维立西呱片,每次2.5mg,qd,与餐同服。2组患者均治疗3个月。比较2组患者的临床疗效、左心室射血分数(LVEF),左心室舒张末期内径(LVEDD)、左心室收缩末期内径(LVESD)、超敏C-反应蛋白(hs-CRP)、白细胞介素-6(IL-6)、一氧化氮(NO)、N-末端脑钠肽前体(NT-proBNP)、尿素氮(BUN)和肌酸酐(SCr)水平,以及安全性,并比较2组患者随访期间心力衰竭再住院率和主要不良心血管事件发生率。结果试验组和对照组各入组53例。治疗后,试验组和对照组的总有效率分别为94.34%(50例/53例)和81.13%(43例/53例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的LVEF分别为(48.02±5.20)%和(43.02±4.33)%,LVEDD分别为(52.85±6.30)和(55.63±6.88)mm,LVESD分别为(41.64±6.40)和(44.22±5.85)mm,hs-CRP水平分别为(10.22±2.63)和(14.60±2.98)mg·L^(-1),IL-6水平分别为(14.48±2.40)和(17.36±2.52)pg·mL^(-1),NO水平分别为(102.60±20.16)和(92.16±16.33)μmol·L^(-1),NT-proBNP水平分别为(898.74±102.20)和(1315.60±182.64)ng·L^(-1),BUN水平分别为(12.02±2.28)和(13.45±2.33)mmol·L^(-1),SCr水平分别为(82.22±5.89)和(85.64±6.03)μmol·L^(-1),因心力衰竭再入院率分别为5.66%和13.21%,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有高钾血症、低血压、肾功能损害、眩晕和头痛,对照组的药物不良反应主要有肾功能损害、高钾血症和低血压。试验组的不良心血管事件主要有心绞痛和急性心肌梗死,对照组的不良心血管事件主要有心绞痛、急性心肌梗死和心房颤动。试验组和对照组的总药物不良反应发生率分别为13.21%和7Objective To observe the clinical efficacy and safety of vericiguat tablets combined with sacubitril valsartan sodium(Sac/Val)tablets in the treatment of patients with heart failure with reduced ejection fraction(HFrEF).Methods The HFrEF patients were divided into control group and treatment group according to the cohort method.The control group was treated with Sac/Val tablets 200 mg per time,bid,orally.On the basis of control group,the treatment group was treated with vericiguat tablets 2.5 mg per time,qd,taken with meal.Two groups were treated for 3 months.The clinical efficacy,left ventricular ejection fraction(LVEF),left ventricular end-diastolic dimension(LVEDD)and end-systolic diameter(LVESD),levels of high sensitivity C-reactive protein(hs-CRP),interleukin-6(IL-6),nitric oxide(NO),N-terminal pro-brain natriuretic peptide(NT-proBNP),blood urea nitrogen(BUN)and serum creatinine(SCr),and safety were compared between the two groups.During follow-up,the heart failure rehospitalization rates and major adverse cardiovascular events were compared between the two groups.Results Treatment group was enrolled 53 patients,control group was enrolled 53 patients.After treatment,the total effective rates of treatment and control groups were 94.34%(50 cases/53 cases)and 81.13%(43 cases/53 cases)with statistical significant difference(P<0.05).After treatment,the LVEF of treatment and control groups were(48.02±5.20)% and(43.02±4.33)%,the LVEDDs were(52.85±6.30)and(55.63±6.88)mm,the LVESDs were(41.64±6.40)and(44.22±5.85)mm,the levels of hs-CRP were(10.22±2.63)and(14.60±2.98)mg·L^(-1),the levels of IL-6 were(14.48±2.40)and(17.36±2.52)pg·mL^(-1),the levels of NO were(102.60±20.16)and(92.16±16.33)μmol·L^(-1),the levels of NT-proBNP were(898.74±102.20)and(1315.60±182.64)ng·L^(-1),the levels of BUN were(12.02±2.28)and(13.45±2.33)mmol·L^(-1),the levels of SCr were(82.22±5.89)and(85.64±6.03)μmol·L^(-1),the heart failure rehospitalization rates were 5.66% and 13.21%,respectively;the differences were statist

关 键 词：维立西呱片 沙库巴曲缬沙坦钠片 射血分数降低 心力衰竭 安全性评价 

分 类 号：R972[医药卫生—药品]