门冬胰岛素30注射液治疗糖尿病的疗效及安全性比较:多中心、随机、开放、对照研究  

Efficacy and safety of biphasic insulin aspart 30 in the treatment of diabetic patients:a multicenter,randomized,open-labeled controlled trial

作　　者：陆菊明[1] 莫朝晖[2] 吕肖锋[3] 王长江[4] 肖常青[5] 李玲[6] 张力辉[7] 叶山东 周智广[9] 杨金奎[10] 张莹[11] 栾健[12] 刘红[13] 孙皎 石勇铨[15] 文重远[16] 任艳[17] 李延兵[18] 赵维纲[19] 余学锋 Lu Juming;Mo Zhaohui;Lyu Xiaofeng;Wang Changjiang;Xiao Changqing;Li Ling;Zhang Lihui;Ye Shandong;Zhou Zhiguang;Yang Jinkui;Zhang Ying;Luan Jian;Liu Hong;Sun Jiao;Shi Yongquan;Wen Zhongyuan;Ren Yan;Li Yanbing;Zhao Weigang;Yu Xuefeng(Department of Endocrinology,the First Medical Center of PLA General Hospital,Beijing 100853,China;Department of Endocrinology,the Third Xiangya Hospital of Central South University,Changsha 410031,China;Department of Endocrinology,the Military General Hospital of Beijing PLA,Beijing 100095,China;Department of Endocrinology,the First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Department of Endocrinology,the First Affiliated Hospital of Guangxi Medical University(West Courtyard),Nanning 530007,China;Department of Endocrinology,Shengjing Hospital of China Medical University,Shenyang 110004,China;Department of Endocrinology,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China;Department of Endocrinology,the First Affiliated Hospital of University of Science and Technology of China,Hefei 230001,China;Department of Endocrinology,the Second Xiangya Hospital of Central South University,Changsha 410011,China;Department of Endocrinology,Beijing Tongren Hospital,Capital Medical University,Beijing 100005,China;Department of Endocrinology,the Third Affiliated Hospital of Guangzhou Medical University,Guangzhou 510150,China;Department of Endocrinology,Qingdao Municipal Hospital,Qingdao 266011,China;Department of Endocrinology,the First Affiliated Hospital of Guangxi Medical University(East Courtyard),Nanning 530021,China;Department of Endocrinology,Huadong Affiliated Hospital of Fudan Medical University,Shanghai 200040,China;Department of Endocrinology,Shanghai Changzheng Hospital,Shanghai 200003,China;Department of Endocrinology,Renmin Hospital of Wuhan University,Wuhan 430060,China;Department of Endocrinology,West China Hospital Sichuan University,Chengdu 610044,China;Department of Endocrinology,the First Affiliated Hospital,Sun Yat-sen University,Guangz

机构地区：[1]解放军总医院第一医学中心内分泌科,北京100853 [2]中南大学湘雅三医院内分泌科,长沙410031 [3]北京军区总医院内分泌科,100095 [4]安徽医科大学第一附属医院内分泌科,合肥230022 [5]广西医科大学第一附属医院(西院)内分泌代谢病科,南宁530007 [6]中国医科大学附属盛京医院内分泌科,沈阳110004 [7]河北医科大学第二医院内分泌科,石家庄050000 [8]中国科学技术大学附属第一医院内分泌科,合肥230001 [9]中南大学湘雅二医院内分泌科,长沙410011 [10]首都医科大学附属北京同仁医院内分泌科,100005 [11]广州医科大学附属第三医院内分泌科,510150 [12]青岛市市立医院内分泌科,266011 [13]广西医科大学第一附属医院(东院)老年内分泌代谢科,南宁530021 [14]复旦大学附属华东医院内分泌科,上海200040 [15]上海长征医院内分泌科,200003 [16]武汉大学人民医院内分泌科,430060 [17]四川大学华西医院内分泌科,成都610044 [18]中山大学附属第一医院内分泌科,广州510080 [19]中国医学科学院北京协和医院内分泌科,100730 [20]华中科技大学同济医学院附属同济医院内分泌科,武汉430030

出　　处：《中华糖尿病杂志》2021年第4期416-421,共6页CHINESE JOURNAL OF DIABETES MELLITUS

摘　　要：目的探讨门冬胰岛素30注射液(联邦优倍灵^(®)30)治疗糖尿病患者的有效性及安全性。方法该研究为多中心、随机、开放、阳性药对照临床试验。2013年10月至2014年10月,纳入预混胰岛素单一治疗或联合1~2种口服降糖药治疗血糖控制不佳的1型糖尿病或2型糖尿病患者,按照1∶1的比例分配至联邦优倍灵^(®)30或门冬胰岛素30组(诺和锐®30组),比较两组受试者治疗24周前后糖化血红蛋白(HbAlc)、空腹血糖(FPG)和餐后2 h血糖(2hPG)的变化及低血糖事件和不良反应的发生率。组内比较采用配对t检验或秩和检验,组间比较采用方差分析或Wilcoxon秩和检验。结果试验共纳入受试者668例,完全符合方案病例共618例(联邦优倍灵^(®)30组305例、诺和锐®30组313例)。治疗24周后,联邦优倍灵^(®)30组和诺和锐®30组HbA_(1c)、FPG和2hPG均较基线值显著下降。经过24周的治疗,联邦优倍灵^(®)30组和诺和锐®30组的HbA_(1c)较治疗前分别下降(1.38±1.33)%和(1.37±1.53)%,治疗后的变化值差异无统计学意义(P>0.05)。两组的FPG分别降低(2.28±3.76)、(1.67±3.55)mmol/L,下降值的组间差异有统计学意义(P=0.03)。联邦优倍灵^(®)30组和诺和锐®30组的2hPG分别下降(3.22±5.38)、(2.78±4.83)mmol/L,下降的差异无统计学意义(P=0.27)。联邦优倍灵^(®)30组和诺和锐®30组低血糖事件发生率分别为45.6%(151/331)和43.8%(146/333),其他不良反应发生率分别为0.9%(3/331)和0.9%(3/333)。结论联邦优倍灵^(®)30与诺和锐®30控制血糖的总体能力相当,均有良好的安全性,具有良好的临床应用价值。Objective To explore the efficacy and safety of biphasic insulin aspart 30(UBLIN^(®)30)in treatment of diabetic patients.Methods A multicenter,randomized,open-labeled and positive control clinical trial included the patients with type 1 or type 2 diabetes mellitus having poor glucose control after using premixed insulin monotherapy or combine with 1 or 2 oral antidiabetic drugs.All patients were treated with UBLIN^(®)30 or NovoMix^(®)30 for 24 weeks in two groups by a ratio of 1∶1.The decreased value and qualification rates of glycated hemoglobin A1c(HbA_(1c)),fasting blood glucose(FPG)and 2-hour postprandial plasma glucose(2hPG),the incidence of hypoglycemic and the adverse events were compared at the end of 24 weeks.Analysis of variance(ANOVA)test,t test and Wilcoxon test were used.Results All of 668 cases were included in the trial,but 618 cases were in complete conformity to the design plan(305 cases received UBLIN^(®)30 therapy and 313 cases received NovoMix^(®)30 therapy).At the end of 24-week treatment period,HbA_(1c) in UBLIN^(®)30 group and NovoMix^(®)30 group decreased by(1.38±1.33)%and(1.37±1.53)%,respectively,compared with the pre-treatment period,and the differences in the post-treatment change values were not statistically significant(P>0.05).FPG decreased by(2.28±3.76)mmol/L and(1.67±3.55)mmol/L in the two groups,respectively,and the difference between groups in the decreasing values was statistically significant(P=0.03).The 2hPG decreased by(3.22±5.38)mmol/L and(2.78±4.83)mmol/L in UBLIN^(®)30 group and NovoMix^(®)30 group,respectively,and the difference in the decrease was not statistically significant(P=0.27).Moreover,the incidence of hypoglycemic events was 45.6%(151/331)and 43.8%(146/333)in UBLIN^(®)30 group and NovoMix^(®)30 group,respectively,and the incidence of other adverse reactions was 0.9%(3/331)and 0.9%(3/333),respectively.Conclusions UBLIN^(®)30 provided similar glycemic control and safety profiles to NovoMix^(®)30,indicating that UBLIN^(®)30 is a suitable thera

关 键 词：糖尿病 胰岛素 疗效 安全性 

分 类 号：R587.1[医药卫生—内分泌]