恩格列净联合贝那普利治疗2型糖尿病肾病患者的临床研究  

Clinical trial of empagliflozin combined with benazepril in treatment of patients with type 2 diabetic kidney disease

作　　者：黄华桑[1] 蔡佳盈 陈雅玲 张建福 沈世忠[1] HUANG Hua-sang;CAI Jia-ying;CHEN Ya-ling;ZHANG Jian-fu;SHEN Shi-zhong(Department of Nephrology,Quanzhou First Hospital,Quanzhou 362000,Fujian Province,China)

机构地区：[1]泉州市第一医院肾内科,福建泉州362000

出　　处：《中国临床药理学杂志》2024年第23期3380-3384,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察恩格列净片联合盐酸贝那普利片治疗2型糖尿病肾病患者的临床疗效和肾结局的作用。方法将2型糖尿病肾病患者随机分为试验组和对照组。对照组给予盐酸贝那普利片10 mg,口服,qd;试验组在对照组治疗的基础上,给予口服恩格列净片治疗,初始剂量10 mg,qd,耐受后调整至25 mg,qd。2组患者均持续治疗3个月。比较2组患者的临床疗效、血糖指标[空腹血糖(FPG)、糖化血红蛋白(HbA1c)]、肾功能指标[血清肌酸酐(SCr)、肾小球滤过率(eGFR)]、氧化应激指标[超氧化物歧化酶(SOD)、丙二醛(MDA)]、肾结局和安全性。结果试验组入组63例,脱落2例,最终有61例纳入统计分析;对照组入组63例,脱落2例,最终有61例纳入统计分析。治疗后,试验组和对照组的总有效率分别为88.52%(54例/61例)和73.77%(45例/61例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的外周血FPB水平分别为(5.64±0.58)和(6.31±0.79)mmol·L^(-1),HbA1c水平分别为(6.09±0.75)%和(6.94±0.96)%,SCr水平分别为(111.88±11.45)和(119.41±8.31)μmol·L^(-1),eGFR分别为(64.11±9.04)和(58.92±4.79)mL·min^(-1)·1.73 m^(-2),SOD水平分别为(45.72±5.53)和(39.54±3.97)U·mL^(-1),MDA水平分别为(26.18±3.22)和(30.31±3.65)nmol·mL^(-1),1年不良肾结局发生率分别为6.56%(4例/61例)和19.67%(12例/61例),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(均P<0.001)。试验组的药物不良反应主要有尿路感染、低血糖和头痛,对照组的药物不良反应主要有低血压和头痛。试验组和对照组的总药物不良反应发生率分别为9.84%(6例/61例)和6.56%(4例/61例),在统计学上差异无统计学意义(P>0.05)。结论恩格列净片联合盐酸贝那普利片治疗2型糖尿病肾病患者的临床疗效更好,能够显著降低不良肾结局发生率,且不增加药物不良反应。Objective To observe the role of empagliflozin tablets combined with benazepril hydrochloride tablets on clinical efficacy and renal outcomes in treating type 2 diabetic kidney disease(DKD).Methods Patients with type 2 DKD were divided into treatment group and control group by means of the random number table method.The control group was treated with benazepril hydrochloride tablets(10 mg,qd)and the treatment group was treated with empagliflozin tablets on the basis of the control group.The initial dose was 10 mg,qd,adjusted to 25 mg after tolerance,qd.Two groups were treated for 3 months.The Chin J Clin Pharmacol 3381 Vol.40 No.23 December 2024(Serial No.421)clin ic al efficacy,blood glucose indexes[fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1c)],renal function indexes[serum creatinine(SCr),glomerular filtration rate(eGFR)],oxidative stress indexes[superoxide dismutase(SOD),malondialdehyde(MDA)],renal outcomes and safety were compared between the two groups before and after treatment.Results In the treatment group,63 cases were enrolled,2 cases were lost,and 61 cases were finally included in the statistical analysis.In the control group,63 cases were enrolled,2 cases were lost,and finally 61 cases were included in the statistical analysis.After treatment,the total effective rates in treatment group and control group were 88.52%(54 cases/61 cases)and 73.77%(45 cases/61 cases),respectively(P<0.05).After treatment,the peripheral blood FPB levels in treatment group and control group were(5.64±0.58)and(6.31±0.79)mmol·L^(-1);HbA1c levels were(6.09±0.75)%and(6.94±0.96)%;SCr levels were(111.88±11.45)and(119.41±8.31)μmol·L^(-1);eGFR values were(64.11±9.04)and(58.92±4.79)mL·min^(-1)·1.73 m^(-2);SOD levels were(45.72±5.53)and(39.54±3.97)U·mL^(-1);MDA levels were(26.18±3.22)and(30.31±3.65)nmol·mL^(-1);the incidence rates of adverse renal outcomes were 6.56%(4 cases/61 cases)and 19.67%(12 cases/61 cases),respectively,with statistical differences(all P<0.05).The adverse drug reactions in treatme

关 键 词：恩格列净片 盐酸贝那普利片 2型糖尿病肾病 临床疗效 肾结局 

分 类 号：R972[医药卫生—药品]