中国老年和中青年糖尿病患者使用双时相门冬胰岛素30的疗效及安全性：来自 A1 chieve 研究结果

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

目的：评价中国老年2型糖尿病（T2DM）患者使用双时相门冬胰岛素30（BIAsp30）的安全性及有效性，并与中青年患者研究结果进行比较。方法2008年11月至2011年3月从全国130家研究中心招募11020例T2DM患者进行前瞻性、多中心、开放、非干预的A1 chieve研究，为期24周。本文分析所有在研究中使用BIAsp30治疗的患者。研究对象分为老年组（年龄＞65岁）和中青年组（年龄≤65岁），同时以研究前是否使用过胰岛素进行分组对比观察BIAsp30的疗效。各组糖化血红蛋白（ HbA1c）水平采用ANCOVA模型分析，低血糖事件采用McNemar′s配对比例检验分析。结果老年组1969例，中青年6508例接受BIAsp 30治疗。24周BIAsp30治疗期间无严重药物不良反应。老年组患者的总体夜间和重度低血糖事件分别从基线时的2.84、0.91和0.34次/患者年下降至2.00、0.41和0次/患者年，中青年组低血糖事件从基线时的2.19、0.48和0.10次/患者年，下降至1.39、0.23和0次/患者年。老年组和中青年组患者用药24周后HbA1c分别比基线时降低[治疗后（7.0±1.0）％和（7.0±1.0）％；基线（9.3±2.3）％和（9.6±2.3）％；老年t＝-33.47，P＜0.001；中青年t＝-67.94，P＜0.001]；老年和中青年组患者HbA1c＜7.0％的达标率比基线增高[基线为13.8％（223/1620）和9.5％（514/5390），治疗后为57.7％（682/1182）和55.0％（2124/3863）]。BIAsp 30治疗24周后，老年组和中青年组的空腹血糖均比基线降低[治疗后（6.8±1.2） mmol/L和（6.7±1.3） mmol/L；基线（9.8±3.5） mmol/L和（10.4±3.6） mmol/L，老年t＝-32.86，P＜0.001；中青年t＝-70.02，P＜0.001]；早餐后2 h血糖分别比基线时下降[治疗后（8.9±1.7）和（8.8±1.8） mmol/L；基线（13.9±4.8）和（14.4±4.9） mmol/L，老年 t ＝-34.14， P ＜0.001；中青年t＝-67.70，P＜0.001]。老年组和中青年组患者的生活质量均有所改善。结论 BIAsp30有效降低血糖，并不增加低血糖风险，特别是降低了夜间和重度低血糖风险，BIAsp30在老年和中青年患者中使用同样安全有效。

Objective To evaluate the efficacy and safety of biphasic insulin aspart 30 （BIAsp30）, and quality of life in Chinese elderly patients （ 〉65 years-old ） with type 2 diabetes in regular clinical practice, and to compare with the data from Chinese young patients （≤65 years-old）.Methods A1 chieve study is a 24 weeks, prospective, multi-center, open-label, non-interventional research.Patients were grouped by age , and further grouped into insulin-naive and insulin-experienced , respectively.Results A＆amp;nbsp;total of 1 969 elderly patients and 6 508 young, who were treated with BIAsp30 during the A1 chieve research in China, were analyzed.No serious adverse drug reaction was reported.The rate of total, nocturnal, and major hypoglycemic events were 2.84/0.91/0.34 event/patient-year, reported by elderly patients with diabetes at baseline, and were decreased to 2.00/0.41 （P=0.0371）/0 event/patient-year, respectively, after 24 weeks treatment with BIAsp 30.The corresponding rates reported by young patients were reduced from 2.19/0.48/0.10 event/patient-year at baseline to 1.39/0.23 （P〈0.001）/0 event/patient-year at 24 weeks, respectively.HbA1c decreased from （9.3 ±2.3）% and （9.6 ±2.3）% at baseline to （7.0 ± 1.0）%and （ 7.0 ±1.0 ）% at end of study in elderly and young patients , respectively （ elderly t =-33.47, P〈0.001;young t=-67.94, P〈0.001）.The proportion of elderly and young patients who achieved HbA1c 〈7% increased from 13.8% （ 223/1 620 ） and 9.5% （ 514/5 390 ） at baseline to 57.7%（682/1 182） and 55.0% （2 124/3 863） at end of the study.Fasting plasma glucose decreased from （9.8 ±3.5） and （10.4 ±3.6） mmol/L at baseline to （6.8 ±1.2） and （6.7 ±1.3） mmol/L at end of study （elderly t=-32.86, P〈0.001; young t=-70.02, P〈0.001）; postprandial plasma glucose （after breakfast） reduced from （13.9 ±4.8） and （14.4 ±4.9） mmol/L at baseline to （8.9 ±1.7） and （8.8 ±1.8） mmol/L at end of study （elderly t=-34.14, P〈0.001;young t=-67.70,P〈0.001）, in elderly and young patients , respectively.The quality of life were significantly ameliorated in both elderly and young patients.Conclusions BIAsp30 improved glycemic control effectively , without increasing the risk of hypoglycemia , and particularly reduced the risk of nocturnal and major hypoglycemia.The application of BIAsp30 is similarly effective and safe in both Chinese elderly and young patients with type 2 diabetes.