双时相门冬胰岛素30在中国人群中的临床应用——A1chieve观察性研究结果

目的在A1chieve国际多中心、前瞻性、开放标签的观察性研究中，提供双时相门冬胰岛素30（以下简称门冬胰岛素30）在中国常规2型糖尿病临床治疗中有关安全性和疗效方面的数据。方法于2008年11月至2011年3月，在全国130家研究中心入组曾用或未用药治疗但血糖控制不佳、经医师判断需要并起始门冬胰岛素30的2型糖尿病患者，分为总体研究人群（包括8578例接受门冬胰岛素30治疗的中国2型糖尿病患者）、亚组研究人群（包括1191例由预混人胰岛素转为门冬胰岛素30治疗的患者）。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。采用配对t检验、Fisher精确概率检验等进行统计学分析。结果经过24周治疗，总体研究人群的所有低血糖事件、重度低血糖事件、夜间低血糖事件发生率（次／人年）分别从基线时2．32、0．15、0．58下降至1．54、0．00、0．28（Fisher精确概率检验P〈0．05，P〈0．01，P〈0．01）。基线时，总体研究人群的糖化血红蛋白为（9．5±2．3）％，治疗24周后下降至（7．0±l.0）％（P〈0．01）；空腹和餐后2h血糖后分别下降（3．5±3．6）mmo]／L和（5．5±5．0）mmol／L（均P〈0．01）。亚组患者的所有低血糖事件、重度低血糖事件、夜间低血糖事件发生率（次／人年）分别从基线时7．20、0．51、2．15下降至2．37、0．00、0．43（均P〈0．01）。治疗24周后，亚组患者的糖化血红蛋白由基线时（8．7±2．1）％下降至（7．0±1．1）％（P〈0．01）。结论血糖控制不佳的中国2型糖尿病患者，无论既往是否接受过口服降糖药或胰岛素治疗，接受门冬胰岛素30治疗24周后耐受性和安全性良好，显著改善血糖控制。

Safety and effectiveness of biphasic insulin aspart 30 in Chinese patients with type 2 diabetes results from the A1 chieve study

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 treatments. Methods Alchieve study was a prospective, open-label, 24-week observational study in patients with type 2 diabetes initiating insulin analogues therapy in routine clinical practice. From November 2008 to March 2011, 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 overall study population contains 8578 Chinese patients with T2DM who were treated with BIAsp 30. Among the overall study population, a subgroup of 1191 patients was treated with biphasic human insulin before study. The treatment regimen and dosing adjustment were decided at physician＇s discretion. Results The rates of total, major, and nocturnal hypoglyceamia （events/patient/year） of the overall study population were 2. 32, 0. 15, 0. 58 at baseline and 1.54, 0.00, O. 28 at week 24 for the overall population （ Fisher exact test P 〈 O. 05, P 〈 0. 01, P 〈0. 01）. Glycaemic control was poor at baseline reflected by HbAlc （9. 5 ± 2. 3） %. After 24 weeks treatment, HbAle of the overall study population decreased to （7.0 ± 1.0） % （P 〈0. 01 ）. Fasting plasma glucose （FPG） and post-prandial plasma glucose （PPG） were both improved for the overall population （changes were （ 3.5 ±3.6） mmol/L and （ -5.5 ±5.0） mmol/L, with both P value 〈0. 01 ）. The rates of total, major, and nocturnal hypoglyceamia （events/patient/year） were 7.20, 0. 51, 2. 15 at baseline and 2. 37,0. 00, 0.43 at week 24 for subgroup patients （ all P value 〈 0. 01 ）. The HbA1 c of these patients decreased from （8.7 ± 2. 1 ） % at baseline to （7.0 ± 1.1 ） % at week 24 （ P 〈 0. 01 ）. Conclusion Beginning BIAsp 30 therapy in Chinese patients with T2DM inadequately controlled on previous treatment is associated with marked improvements in glycaemic control, without evidence of clinically significant safety or tolerability concerns, regardless of the previous treatment regimen.