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  

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

作　　者：王昕宇 张云迪 李越 宗慧颖 韩文倩 刘伦[3] 王倩 郭鲁波 狄会峰 甄晓慧[6] 孙德清[6] 苏英 张宗林[7] 彭净[8] 曹晓孚[8] 刘宁[9] 刘健[9] 卢翠翠 王丽 耿涛 李荣绩 孙国栋[13] 张帆[13] 张琳[14] 马传江[14] 谭斯元 钱东方 李妍[16] 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)

机构地区：[1]山东第一医科大学(山东省医学科学院)药学院(药物研究所),济南250117 [2]山东中医药大学药学院,济南250355 [3]青岛大学附属泰安市中心医院药学部,泰安271099 [4]山东第一医科大学附属中心医院药学部,济南250013 [5]济南市人民医院药学部,济南250102 [6]山东大学第二医院药学部,济南250033 [7]临沂市人民医院药学部,临沂276034 [8]济宁医学院附属医院药学部,济宁272007 [9]山东中医药大学第二附属医院药学部,济南250001 [10]山东第一医科大学附属省立医院药学部,济南250021 [11]山东第一医科大学第二附属医院药学部,泰安271000 [12]济南市章丘区人民医院药学部,济南250299 [13]聊城市人民医院药学部,聊城252004 [14]山东中医药大学附属医院药学部,济南250011 [15]北京北方医药健康经济研究中心,北京100101 [16]山东第一医科大学第一附属医院(山东省千佛山医院)临床药学,济南250014

出　　处：《药物不良反应杂志》2023年第11期649-655,共7页Adverse Drug Reactions Journal

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.

关 键 词：2型糖尿病 德谷胰岛素 甘精胰岛素 安全性 血糖 多中心研究 队列研究 

分 类 号：R587.1[医药卫生—内分泌]