达格列净对绝经后女性2型糖尿病患者血糖控制及骨密度的影响  

Effects of Dapagliflozin on glycemic control and bone mineral density in postmenopausal women with type 2 diabetes mellitus

作　　者：李诗琦 陈超[1] 邢学农[1] 叶山东[1] LI Shi-qi;CHEN Chao;XING Xue-nong;YE Shan-dong(Department of Endocrinology,the Anhui Provincial Hospital Affiliated to Anhui Medical University,Hefei 230001,China)

机构地区：[1]安徽医科大学附属省立医院,安徽省立医院内分泌科,合肥230001

出　　处：《中华骨质疏松和骨矿盐疾病杂志》2020年第4期311-317,共7页Chinese Journal Of Osteoporosis And Bone Mineral Research

基　　金：安徽省中央引导地方科技发展专项(2017070802D147);安徽省卫生厅医学科研课题(13zc003)。

摘　　要：目的评估达格列净联合二甲双胍和格列美脲治疗对绝经后女性2型糖尿病(type 2 diabetes mellitus,T2DM)患者血糖控制和骨密度(bone mineral density,BMD)的影响。方法选取二甲双胍联合格列美脲治疗12周但血糖控制不佳的绝经后女性T2DM患者151例,按照随机数字法将研究对象分为达格列净组76例和甘精胰岛素组75例。两组均在联合二甲双胍和格列美脲治疗基础上分别加用达格列净和甘精胰岛素52周,观察基线和治疗后血糖指标和BMD水平、骨质疏松症(osteoporosis,OP)患病率、骨折风险预测工具(fracture risk assessment tool,FRAX)评分、骨代谢标志物和体脂率(body fat percentage,BF)的变化。结果治疗后,达格列净组和甘精胰岛素组糖基化血红蛋白(hemoglobin A1c,Hb A1c)水平分别为(7.52±0.81)%和(7.49±0.68)%,空腹血糖(fasting plasma glucose,FPG)水平分别为(7.21±0.81)和(7.34±0.89)mmol/L,均较治疗前明显降低(P<0.01)。治疗期间达格列净组低血糖发生率低于甘精胰岛素组(11.8%vs.25.3%,P<0.05)。治疗后,达格列净组体质量、体质量指数及BF均较治疗前降低,且BF低于甘精胰岛素组[(37.46±5.92)%vs.(39.31±5.58)%,P<0.05]。两组治疗前后骨代谢标志物包括25-羟维生素D、骨钙素、I型原胶原N-端前肽、1型胶原β-C-末端肽交联、BMD、OP患病率及FRAX评分包括10年发生主要骨质疏松性骨折概率和10年发生髋部骨折概率无明显变化,且组间差异均无统计学意义(均P>0.05)。结论达格列净在有效控制绝经后女性T2DM患者血糖的同时,可降低其体质量和BF,对BMD和骨折风险无不良影响。Objective To investigate effects of Dapagliflozin combined with Metformin and Glimepiride on glycemic control and their effects on bone mineral density(BMD)in postmenopausal women with type 2 diabetes mellitus(T2DM).Methods A total of 151 postmenopausal women with T2DM were enrolled and divided into two groups by random number method:the Dapagliflozin group(n=76)and the Glargine group(n=75).Subjects in the groups were given combined treatment with metformin and glimepiride for 52 weeks.From baseline to week 52,the following parameters in all subjects were evaluated:BMD,bone turnover markers(BTMs),fracture risk assessment(FRAX),osteoporosis prevalence,body fat percentage(BF),body weight,fasting plasma glucose(FPG)and hemoglobin A1c(HbA1c).Results After treatment,HbA1c were decreased in Dapagliflozin group[(7.52±0.81)%]and Glargine group[(7.49±0.68)%]compared with baseline(P<0.01).FPG were decreased in Dapagliflozin group[(7.21±0.81)mmol/L]and Glargine group[(7.34±0.89)mmol/L],compared with baseline(P<0.01).Rates of hypoglycemia were lower in Dapagliflozin group than in Glargine group(11.8%vs.25.3%,P<0.05).After treatment,body weight,body mass index(BMI),and BF were decreased significantly in Dapagliflozin group than baseline(P<0.05 or P<0.01).Moreover,BF in Dapagliflozin group was decreased significantly than that in Glargine group[(37.46±5.92)%vs.(39.31±5.58)%,P<0.05].The BMD,osteoporosis incidence,FRAX score[10-year probability of the major osteoporotic fracture risk(PMOF),10-year probability of the hip fracture risk(PHF)]and BTMs[25 OHD,osteocalcin(OC),typeⅠcollagen n-terminal propeptide(P1 NP),typeⅠcollagen cross-linked C-terminal telopeptide(β-CTX)]were not significantly different in Dapagliflozin group and Glargine group compared with baseline(all P>0.05).There were no differences in BMD,osteoporosis incidence,FRAX score,and BTMs between two groups as well(all P>0.05).Conclusion Treatment with dapagliflozin for 52 weeks significantly improved glycemic control and reduced body weight and BF without

关 键 词：2型糖尿病 绝经后女性 达格列净 骨密度 体脂率 

分 类 号：R587[医药卫生—内分泌] R683[医药卫生—内科学]