达格列净对HFpEF合并T2DM患者心血管保护作用的临床研究  

Clinical trial of cardiovascular protective effect of dapagliflozin on patients with HFpEF complicated with T2DM

作　　者：刘左玲 凌云 方凌燕 LIU Zuo-ling;LING Yun;FANG Ling-yan(Department of Cardiovascular Medicine,Second Affiliated Hospital of Guangdong Medical University,Zhanjiang 524000,Guangdong Province,China)

机构地区：[1]广东医科大学附属第二医院心血管内科,广东湛江524000

出　　处：《中国临床药理学杂志》2025年第1期11-15,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的探究达格列净对射血分数保留的心力衰竭(HFpEF)合并2型糖尿病(T2DM)患者的心血管保护作用。方法将HFpEF合并T2DM患者按照队列法分为试验组和对照组。对照组给予盐酸二甲双胍片每次0.5g,bid,口服;试验组在对照组治疗的基础上,给予达格列净片每次10mg,qd,口服。2组患者均持续用药6个月。比较2组患者的临床疗效,比较2组患者治疗前后血糖指标[空腹血糖(FBG)、餐后2 h血糖(2hPBG)、糖化血红蛋白(HbA1c)]、超声心动图左心参数[射血分数(LVEF)、左室舒张末内径(LVEDD)、左心室重构指数(LVRI)、左心室质量指数(LVMI)]及血清N末端脑钠肽前体(NT-proBNP)、血清心肌纤维化指标[基质金属蛋白酶-9(MMP-9)、基质金属蛋白酶组织抑制因子-1(TIMP-1)]的变化,进行安全性评价。结果试验组与对照组分别入组75例和72例。治疗后,试验组和对照组总有效率分别为93.33%(70例/75例)和81.94%(59例/72例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组患者的FBG、2hPBG、HbA1c、LVEF、LVEDD比较,在统计学上差异均无统计学意义(均P>0.05)。治疗后,试验组和对照组患者的LVRI分别为(2.17±0.41)和(2.54±0.46)g·mL^(-2),LVMI分别为(102.47±10.32)和(113.84±15.52)g·m^(-2),血清NT-proBNP水平分别为(652.38±208.26)和(993.24±302.69)pg·mL^(-1),MMP-9水平分别为(142.52±21.67)和(168.73±25.88)mg·L^(-1),TIMP-1水平分别为(3.68±0.84)和(3.12±0.91)μg·L^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应总发生率分别为14.67%(11例/75例)和12.50%(9例/72例),在统计学上差异无统计学意义(P>0.05)。结论达格列净治疗HFpEF合并T2DM患者,可改善患者心室重构、提高心功能,具有显著心血管保护作用。Objective To explore the cardiovascular protective effect of dapagliflozin on patients with heart failure with preserved ejection fraction(HFpEF)complicated with type 2 diabetes mellitus(T2DM).Methods Patients with HFpEF complicated with T2DM were divideidnto treatment group and control group according to cohort method.TThe control group was given 0.5 g of metformin hydrochloride tablet orally twice a day,while the treatment group was given 10 mg of dapagliflozin tablet orally once a day on the basis of treatment in the control group.Patients in both groups were continuously treated for 6 months.The clinical efficacy after treatment and blood glucose indicators[fasting blood glucose(FBG),2 hours postprandial blood glucose(2 h PBG),glycosylated hemoglobin(HbA1c)],echocardiographic left ventricular parameters[left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD),left ventricular remodeling index(LVRI),left ventricular mass index(LVMI)]and serum N-terminal pro-brain natriuretic peptide(NT-proBNP),serum myocardial fibrosis indicators[matrix metalloproteinase-9(MMP-9),tissue inhibitor of metalloproteinase-1(TIMP-1)]before and after treatment were compared between both groups,and the safety evaluation was performed.Results Seventy-five cases in treatment group and 72 cases in control group were included.After treatment,the total effective rates in treatment group and control group were 93.33%(70 cases/75 cases)and 81.94%(59 cases/72 cases),respectively(P<0.05).After treatment,the levels of FBG,2 h PBG,HbA1c,LVEF and LVEDD revealed no statistical differences between treatment group and control group(all P>0.05).After treatment,LVRI values in treatment group and control group were(2.17±0.41)and(2.54±0.46)g·mL^(-2);LAMI values were(102.47±10.32)and(113.84±15.52)g·m^(-2);serum NT-proBNP levels were(652.38±208.26)and(993.24±302.69)pg·mL^(-1);MMP-9 levels were(142.52±21.67)and(168.73±25.88)mg·L^(-1);TIMP-1 levels were(3.68±0.84)and(3.12±0.91)μg·L^(-1),respectively(all P<0.05)

关 键 词：达格列净片 射血分数保留的心力衰竭 2型糖尿病 心血管保护作用 心功能 心肌纤维化 

分 类 号：R972[医药卫生—药品]