达格列净片治疗2型糖尿病合并慢性心力衰竭患者的临床研究  

Clinical trial of dapagliflozin in the treatment of type 2 diabetes mellitus with chronic heart failure

作　　者：张邻川[1] 夏成功[2] 唐文明[1] 周丽英 郑武扬[3] ZHANG Lin-chuan;XIA Cheng-gong;TANG Wen-ming;ZHOU Li-ying;ZHENG Wu-yang(Department of Cardiology,Xinglin Branch,The First Affiliated Hospital of Xiamen University,Xiamen 361022,Fujian Province,China;Department of Pharmacy,People,s Hospital of Sishui County,Jining 273200,Shandong Province,China;Department of Cardiology,The First Affiliated Hospital of Xiamen University,Xiamen 361003,Fujian Province,China)

机构地区：[1]厦门大学附属第一医院杏林分院心内科,福建厦门361022 [2]济宁市泗水县人民医院药剂科,山东济宁273200 [3]厦门大学附属第一医院心内科,福建厦门361003

出　　处：《中国临床药理学杂志》2021年第19期2573-2576,2595,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的探究达格列净治疗2型糖尿病(T2DM)合并慢性心力衰竭(CHF)患者的疗效和安全性及对心室重构的影响。方法将CHF患者随机分为2组:对照组41例和试验组41例。2组在接受CHF标准化药物治疗的基础上,对照组执行基础降糖方案,试验组每次口服达格列净5 mg,治疗3个月后糖化血红蛋白水平无改善者,达格列净调整为10 mg·d^(-1),1次/天。比较2组患者预后情况,观察2组的药物不良反应(ADR)。于治疗前及治疗后6个月进行多普勒超声检查测定心室重构参数水平,同时于相应时点测定心室重构生化指标。结果治疗后,试验组和对照组右心室舒张末期容积(RVEDV)分别为(61.17±5.45),(65.97±5.64) mL,右心室收缩末期容积(RVESV)分别为(30.64±3.29),(39.07±3.47) mL,左心室质量指数(LVMI)分别为(98.83±8.76),(105.69±8.85) kg·L^(-1),左心室重构指数(LVRI)分别为(2.22±0.32),(2.78±0.37) g·m^(-2),成纤维细胞生长因子23(FGF23)分别为(321.49±24.12),(509.80±49.74)μg·L^(-1),基质金属蛋白酶9(MMP-9)分别为(151.09±14.54),(185.02±16.93) mg·L^(-1),胱抑素C(Cys C)分别为(0.95±0.12),(1.60±0.24) mg·L^(-1),核因子κB (NF-κB)分别为(39.19±4.47),(54.79±4.99) ng·L^(-1)差异均有统计学意义(均P<0.05)。试验组发生低血糖有1例(2.44%),明显低于对照组的7例(17.07%),组间比较差异有统计学意义(P<0.05),2组因CHF恶化再入院发生率和ADR比较差异均无统计学意义(均P>0.05)。结论达格列净能够有效抑制T2DM合并CHF患者的心室重构进程,进而促进心功能恢复、提高生活质量并改善预后,同时安全性较高。Objective To explore the curative effect,safety of dapagliflozin and its effect on the ventricular remodeling of patients with type 2 diabetes(T2 DM) combined with chronic heart failure(CHF).Methods CHF patients were randomly divided into two groups:Control group of 41 cases and treatment group of 41 cases.Both groups received CHF standardized drug treatment.On this basis,the control group implemented a basic hypoglycemic regimen,while the treatment group took 5 mg of dapagliflozin each time.The glycosylated hemoglobin level did not improve after 3 months of treatment,dapagliflozin dose is adjusted to 10 mg·d^(-1),once/day.The prognostic of the two groups of patients was compared.The adverse drugs reaction(ADR) that occurred during the treatment was observed.And perform Doppler ultrasound before and 6 months after the treatment to determine the level of ventricular remodeling parameters,and at the same time to determine the biochemical indicators of ventricular remodeling.Results After treatment,the right ventricular end-diastolic volume(RVEDV) of treatment group and control group were(61.17±5.45),(65.97±5.64) mL;right ventricular end-systolic volume(RVESV) were(30.64±3.29),(39.07±3.47) mL;left ventricular mass index(LVMI) were(98.83±8.76),(105.69±8.85) kg·L^(-1);left ventricular remodeling index(LVRI) were(2.22±0.32),(2.78±0.37) g·m^(-2);fibroblast growth factor 23(FGF23) were(321.49±24.12),(509.80±49.74) μg·L^(-1);matrix metalloproteinase 9(MMP-9) were(151.09±14.54),(185.02±16.93) mg·L^(-1);Cystatin C(CysC) were(0.95±0.12),(1.60±0.24) mg·-1;nuclear factor κB(NF-κB) were(39.19±4.47),(54.79±4.99) ng·L^(-1).Compared between treatment group and control group,the difference of the factors were significant(all P <0.05).In addition,hypoglycemia occurred in 1 case(2.44%) in the treatment group,which was significantly lower than 7 cases(17.07%) in the control group(P <0.05),while the incidence of readmission and re-admission due to CHF deterioration were not statistically significant(P> 0.05).C

关 键 词：达格列净 2型糖尿病 慢性心力衰竭 心室重构 心功能 预后质量 

分 类 号：R97[医药卫生—药品]