人胰岛素血糖控制不佳患者改用双时相门冬胰岛素30的治疗结果——A1 chieve国际多中心观察性研究中国亚组结果  

Improved safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetic patients inadequately controlled on human insulin： Chinese subgroup analysis from an international, multicenter A1chieve observational study

作　　者：彭永德[1] 陈兵[2] 庄晓明[3] 李玉坤[4] 俞芳[5] 韩萍[6] 成志峰[7] 沈建国[8] 李蓬秋[9] 莫朝晖[10] 华郁[11] 胡玲[12] 杨文英[13] 

机构地区：[1]上海交通大学附属第一人民医院内分泌与代谢科,200080 [2]第三军医大学西南医院内分泌科 [3]首都医科大学附属复兴医院内分泌科 [4]河北医科大学第三医院内分泌科 [5]唐山工人医院内分泌科 [6]中国医科大学附属第二医院内分泌科 [7]哈尔滨医科大学附属第四医院内分泌科 [8]浙江大学医学院附属第一医院内分泌科 [9]四川省人民医院内分泌科 [10]中南大学湘雅三医院内分泌科 [11]西安市中心医院肾病内分泌科 [12]南昌大学第三附属医院内分泌科 [13]卫生部中日友好医院内分泌科

出　　处：《中华内分泌代谢杂志》2013年第9期740-745,共6页Chinese Journal of Endocrinology and Metabolism

摘　　要：目的观察人胰岛素改用双时相门冬胰岛素30治疗后的疗效和安全性。方法A．thieve是一项国际多中心、前瞻性、观察性、开放标签、非干预性、为期24周的胰岛素类似物研究。本文总结由人胰岛素转为双时相门冬胰岛素30治疗的患者数据。入选患者为经医师判断需要改用门冬胰岛素30的2型糖尿病患者，医师根据临床经验决定治疗方案并进行剂量调整．随访24周。结果1588例因人胰岛素血糖控制不佳而转为接受双时相门冬胰岛素30治疗的中国2型糖尿病患者．进入研究前接受预混入胰岛素治疗的患者比例最高（75．0％）。研究期间未报告严重药物不良反应。经过24周治疗，所有低血糖事件、夜间低血糖事件、重度低血糖事件的发生率（次·人^-1·年^-1）分别从基线时6．54、1．84、0．43下降至2．36、0．45、0（均P〈0．01）；HbA1c从基线时的（8．9±2．3）％，下降至24周时（7．0±1．1）％（P〈0．05）；HbA。达标率（〈7．0％）由基线时17．8％上升至24周时的54．8％。空腹和餐后2hm糖的下降值分别为（-2．3±3．3）mmol／L和（-3．8±4．4）mmol／L（均P〈0．05）。结论接受人胰岛素治疗血糖控制欠佳的中国2型糖尿病患者，改用双时相门冬胰岛素30治疗24周后耐受性和安全性良好，血糖控制得到显著改善。Objective To evaluate clinical safety and effectiveness of biphasic insulin aspart 30 （ BIAsp 30 ） in Chinese patients with type 2 diabetes mellitus （ T2DM ） inadequately controlled on their previous Human insulin regimens. Methods A1chieve was a prospective, open-label, 24-week observational study in patients with T2DM initiating insulin analogues therapy in routine clinical practice. In the present study, the data of patients who shifted prevh}us treatment with human insulin to treatment with BIAsp 30 were summarized and analyzed. Eligible patients who had decided to start BIAsp 30 based on physicians＇ clinical judgments were enrolled into this study from 130 hospitals in China. The treatment regimen and dosing adjustment were decided at physician＇s discretion. Results A total of 1 588 Chinese patients with T2DM inadequately controlled on their previous human insulin regimens were treated with BIAsp 30 in this study, and 75.0% of these patients were treated with premixed human insulin before the study. The incidences of total, nocturnal, and major hypoglyceamia （ events · patient-1 ·year^-1 ） were 6.54, 1.84, 0.43 at baseline and 2.36, 0. 45,0 at week 24（ all P〈0.01 ）. Hb1 Adeereased from （ 8.9 ± 2.3 ） % at baseline to （ 7.0 ± 1. 1 ） % at week 24 （ P〈0.05 ）. The percentage of patients achieving HbA1c 〈7.0 % increased from 17.8 % at baseline to 54.8% by week 24. Fasting plasma glucose and postprandial 2 h plasma glucose levels were decreased by （ -2.3±3.3 ） and （ -3.8 ± 4.4 ） mmol/L, respectively （ both P 〈0.05 ）. Conclusions Treatment with B1Asp 30 in Chinese patients with T2DM, who were inadequately controlled on previous human insulin regimens, is associated with marked improvement in glycaemic control without evidence of clinically significant safety or tolerability problems.

关 键 词：双时相门冬胰岛素30 人胰岛素 糖尿病 2型 胰岛素类似物 低血糖 

分 类 号：R587.1[医药卫生—内分泌]