德谷胰岛素与甘精胰岛素U100治疗2型糖尿病的疗效与安全性评价被引量：1

Efficacy and safety evaluation of insulin degludec and insulin glargine U100 in the treatment for type 2 diabetes mellitus

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摘要目的对比分析德谷胰岛素和甘精胰岛素U100用于治疗2型糖尿病的疗效和安全性。方法本研究为回顾性队列研究,研究对象为2018年9月至2021年12月于山东省13家三级综合医院住院治疗的2型糖尿病患者。根据使用的基础胰岛素种类,将患者分为德谷胰岛素组和甘精胰岛素U100组。收集2组患者的一般资料和实验室检查结果,比较2组患者的空腹血糖水平、低血糖发生率;选择2组中血糖监测数据完整的患者,分析其血糖波动情况。结果本研究共纳入1152例患者,德谷胰岛素组552例,甘精胰岛素U100组600例,2组患者基本情况差异无统计学意义(均P>0.05)。2组患者治疗后空腹血糖水平均低于治疗前,差异有统计学意义[10.2(8.8,12.5)mmol/L比7.5(6.6,8.7)mmol/L,Z=-19.443,P<0.001;10.0(8.6,11.7)mmol/L比7.8(6.6,9.0)mmol/L,Z=-15.449,P<0.001],但2组治疗后空腹血糖水平差异无统计学意义(Z=-1.427,P>0.05)。德谷胰岛素组患者的低血糖发生率低于甘精胰岛素U100组[1.09%(6/552)比2.83%(17/600),Z=4.481,P=0.032]。德谷胰岛素组血糖监测数据完整患者的日内血糖标准差、最大血糖波动幅度、餐后血糖波动幅度和平均血糖波动幅度均显著低于甘精胰岛素U100组患者[(1.7±0.6)mmol/L比(2.4±1.0)mmol/L,(4.5±1.6)mmol/L比(6.7±2.9)mmol/L,(1.8±1.0)mmol/L比(3.3±1.2)mmol/L,(2.9±1.3)mmol/L比(4.6±2.1)mmol/L;均P<0.001]。结论德谷胰岛素治疗2型糖尿病的疗效与甘精胰岛素U100相当,但致低血糖的风险和血糖波动风险较低。 Objective To compare the efficacy and safety of insulin degludec and insulin glargine U100 in patients with type 2 diabetes mellitus.Methods This study was a retrospective cohort study.The subjects were patients with type 2 diabetes mellitus who were hospitalized in 133A‐level general hospitals in Shandong Province from September 2018 to December 2021.According to the type of basal insulin used,the patients were divided into insulin degludec group and insulin glargine U100 group.The basic information and laboratory test results in patients in the 2 groups were collected,the differences of fasting blood glucose level and incidence of hypoglycemia between the 2 groups were compared.The patients with complete blood glucose monitoring data in the 2 groups were selected and their blood glucose fluctuations were compared.Results A total of 1152 patients were entered in the study,including 552 patients in the insulin degludec group and 600 patients in the insulin glargine U100 group.The difference in the basic conditions in patients in the 2 groups was not statistically significant(all P>0.05).After treatment,the fasting blood glucose levels in patients in the 2 groups were lower than those before treatment,with statistically significant differences[10.2(8.8,12.5)mmol/L vs.7.5(6.6,8.7)mmol/L,Z=-19.443,P<0.001;10.0(8.6,11.7)mmol/L vs.7.8(6.6,9.0)mmol/L,Z=-15.449,P<0.001],but the difference in fasting blood glucose levels between the 2 groups after treatment was not statistically significant(Z=-1.427,P>0.05).The incidence of hypoglycemia in the insulin degludec group was lower than that in the insulin glargine U100 group[1.09%(6/552)vs.2.83%(17/600),Z=4.481,P=0.032].The intraday blood glucose standard deviation,maximum blood glucose fluctuation range,postprandial blood glucose fluctuation range,and average blood glucose fluctuation range in patients with complete blood glucose monitoring data in the insulin degludec group were significantly lower than those in the insulin glargine U100 group[(1.7±0.6)mmol/L vs.(2.4±1.

作者王昕宇张云迪李越宗慧颖韩文倩刘伦王倩郭鲁波狄会峰甄晓慧孙德清苏英张宗林彭净曹晓孚刘宁刘健卢翠翠王丽耿涛李荣绩孙国栋张帆张琳马传江谭斯元钱东方李妍 Wang Xinyu;Zhang Yundi;Li Yue;Zong Huiying;Han Wenqian;Liu Lun;Wang Qian;Guo Lubo;Di Huifeng;Zhen Xiaohui;Sun Deqing;Su Ying;Zhang Zonglin;Peng Jing;Cao Xiaofu;Liu Ning;Liu Jian;Lu Cuicui;Wang Li;Geng Tao;Li Rongji;Sun Guodong;Zhang Fan;Zhang Lin;MaChuanjiang;Tan Siyuan;Qian Dongfang;Li Yan(School of Pharmaceutical&Institute of Materia Medica,Shandong First Medical University&Shandong Academy of Medical Science,Ji′nan 250117,China;School of Pharmacy,Shandong University of Traditional Chinese Medicine,Ji′nan 250355,China;Department of Pharmacy,Taian Central Hospital Affiliated to Qingdao University,Shandong Province,Taian 271009,China;Department of Pharmacy,Central Hospital Affiliated to Shandong First Medical University,Ji′nan 250013,China;Department of Pharmacy,Jinan People′s Hospital,Ji′nan 250102,China;Department of Pharmacy,Second Hospital of Shandong University,Ji′nan 250033,China;Department of Pharmacy,Linyi People′s Hospital,Shandong Province,Linyi 276034,China;Department of Pharmacy,Affiliated Hospital of Jining Medical College,Shandong Province,Jining 272007,China;Department of Pharmacy,the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Ji′nan 250001,China;Department of Pharmacy,Shandong First Medical University Affiliated Provincial Hospital,Ji′nan 250021,China;Department of Pharmacy,the Second Affiliated Hospital of Shandong First Medical University,Shandong Province,Taian 271000,China;Department of Pharmacy,Ji′nan Zhangqiu District People′s Hospital,Ji′nan 250229,China;Department of Pharmacy,Liaocheng People′s Hospital,Shandong Province,Liaocheng 252004,China;Department of Pharmacy,Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Ji′nan 250011,China;Beijing North Medical&Health Economic Research Center,Beijing 100101,China;Department of Clinical Pharmacy,the First Affiliated Hospital of Shandong First Medical University&Shandong Provincial Qianfoshan Hospital,Ji′nan 250014,China)