恩格列净与吡格列酮对2型糖尿病合并非酒精性脂肪性肝病患者肝脂肪变性和肝纤维化影响的比较研究  

Comparison of Effects of Empagliflozin and Pioglitazone on Liver Steatosis and Liver Fibrosis in Type 2 Diabetes Mellitus Patients with Non-Alcoholic Fatty Liver Disease

作　　者：史文雯 李萌[2] 毛玉伟 李贺萍 SHI Wenwen;LI Meng;MAO Yuwei;LI Heping(Dept.of Pharmacy,the First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061,China;Dept.of Endocrinology,the First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061,China)

机构地区：[1]西安交通大学第一附属医院药学部,西安710061 [2]西安交通大学第一附属医院内分泌科,西安710061

出　　处：《中国医院用药评价与分析》2024年第12期1472-1475,1479,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：2022年陕西省科学技术研究发展计划项目(No.2022SF-665)。

摘　　要：目的:评价并比较恩格列净与吡格列酮对2型糖尿病(T2DM)合并非酒精性脂肪性肝病(NAFLD)患者肝脂肪变性和肝纤维化的影响。方法:纳入2021年10月至2023年3月于该院治疗的T2DM合并NAFLD患者186例,根据随机数字表法分为恩格列净组(n=93)与吡格列酮组(n=93)。在进行基础治疗的同时,恩格列净组患者口服恩格列净片,1次10 mg,1日1次;吡格列酮组患者口服吡格列酮片,1次30 mg,1日1次;两组患者均连续治疗24周。比较治疗前后恩格列净组与吡格列酮组患者身体测量和身体成分指标、代谢指标、肝酶和胰岛素指标、肝脂肪变性和肝纤维化指标及药品不良反应发生率。结果:治疗后,恩格列净组患者体重、体重指数、躯干脂肪总量和内脏脂肪面积均较吡格列酮组显著降低,差异均有统计学意义(P<0.05)。治疗后,恩格列净组与吡格列酮组患者空腹血糖、糖化血糖蛋白等代谢指标较治疗前显著降低,丙氨酸转氨酶、天冬氨酸转氨酶、胰岛素和胰岛素抵抗指数等肝酶和胰岛素指标较治疗前显著降低,差异均有统计学意义(P<0.05);但两组患者治疗后代谢指标、肝酶和胰岛素指标比较,差异均无统计学意义(P>0.05)。治疗后,恩格列净组患者受控衰减参数[(270.83±34.66)dB/m vs.(287.80±31.14)dB/m,t=3.512,P<0.001]、肝脏硬度值[(5.89±1.77)kPa vs.(6.56±2.25)kPa,t=2.257,P=0.024]较吡格列酮组显著降低,差异均有统计学意义。恩格列净组与吡格列酮组患者的药品不良反应发生率比较,差异无统计学意义[3.2%(3/93)vs.2.2%(2/93),χ^(2)=0.206,P=0.650]。结论:与吡格列酮相比,恩格列净治疗24周可显著改善T2DM合并NAFLD患者的肝脂肪变性和肝纤维化,显著降低患者体重和脂肪含量。OBJECTIVE:To evaluate and compare the effects of empagliflozin and pioglitazone on liver steatosis and liver fibrosis in type 2 diabetes mellitus(T2DM)patients with non-alcoholic fatty liver disease(NAFLD).METHODS:Totally 186 patients with T2DM complicated with NAFLD admitted into the hospital from Oct.2021 to Mar.2023 were extracted to be divided into the empagliflozin group(n=93)and pioglitazone group(n=93)through the random number table method.On the basis of conventional treatment,the empagliflozin group was given oral Engliflozin tablets,10 mg each time,once a day,while the pioglitazone group received oral Pioglitazone tablets,30 mg each time,once a day.Both groups were treated continuously for 24 weeks.Before and after treatment,body measurements and body composition indicators,metabolic indicators,liver enzymes and insulin indicators,liver steatosis and liver fibrosis indicators,and the incidence rate of adverse drug reactions were compared between the empagliflozin group and the pioglitazone group.RESULTS:After treatment,the body mass,body mass index,total trunk fat,and visceral fat area of patients in the empagliflozin group decreased more significantly than those in the pioglitazone group,with statistically significant difference(P<0.05).After treatment,the metabolic indicators such as fasting blood glucose and glycated glycoprotein in the empagliflozin group and pioglitazone group decreased significantly compared with those before treatment,the alanine aminotransferase,aspartate aminotransferase,insulin and insulin resistance indicator and other liver enzymes and insulin indicators decreased significantly compared with those before treatment,with statistically significant difference(P<0.05).There were no significant differences in metabolic indicators,liver enzymes and insulin indicators between two groups after treatment(P>0.05).After treatment,the controlled attenuation parameter[(270.83±34.66)dB/m vs.(287.80±31.14)dB/m,t=3.512,P<0.001]and liver stiffness measurement[(5.89±1.77)kPa vs.(6.56±2.25)

关 键 词：恩格列净 吡格列酮 非酒精性脂肪性肝病 肝脂肪变性 肝纤维化 

分 类 号：R977.15[医药卫生—药品]