口服降糖药联合甘精胰岛素及餐前一次门冬胰岛素的治疗达标研究——1＋1研究

Efficacy of the addition of a single bolus of insulin glulisine in combination with basal insulin glargine and oral antidiabetic drugs

目的观察2型糖尿病患者经口服降糖药联合甘精胰岛素治疗仍未达标时，于餐前增加1次门冬胰岛素的有效性、安全性和可行性。方法采用多中心、开放、自身对照的方法。59例经口服降糖药及甘精胰岛素治疗而糖化血红蛋白（Hb）A1c〉6．5％但〈9％的患者，于主餐前加用门冬胰岛素治疗16周。结果16周后，患者HbA1c由治疗前的（8．04±0．58）％降至（6．78±0．30）％（P〈0．01），其中13例（22．03％）达到≤6．5％，43例（72．88％）达到〈7．0％。早餐前、午餐前及晚餐前注射门冬胰岛素组3餐后血糖均较前明显降低，HbA1c分别为（6．70±0．29）％，（6．80±0．32）％及（6．90±0．21）％。患者低血糖发生率为0．38次／（患者·年），无夜间低血糖和严重低血糖事件发生。患者平均体重及体重指数均明显下降。结论对于口服降糖药联合甘精胰岛素治疗血糖控制欠佳的2型糖尿病患者，于主餐前增加1次门冬胰岛素可以有效、安全地降低患者血糖，提高达标率，且具有较高可行性。

Objective To investigate the efficacy, safety and feasibility of the addition of a single bolus of insulin glulisine before meal, in combination with basal insulin glargine and oral antidiabetie drugs （OADs） in the treatment of patients with type 2 diabetes. Methods 59 patients with type 2 diabetes who were suboptimally controlled （ HbAlc 6. 5% -9. 0% ） on their previous glargine and OADs regimen were included in this 16 weeks, muhicentre,open-label and self-control study. A single injection of glulisine was added, at main mealtime, to their existing therapy. Results HbA1 c was decreased from （8.04 ± 0.58） % to （6.78 ± 0.30 ） % after 16 weeks（ P 〈 0.01 ）. 13 patients（22.03% ） obtained the target of HbA1 c ≤〈6.5%, 43 patients （72.88%）obtained the target of HbA1c 〈 7.0%. Glulisine given at breakfast,lunch or dinner was equally effective in controlling plasma glucose level, and the HbA1 c was （ 6.70 ± 0.29 ） % , （ 6.80 ±0.32 ） %, （ 6.90 ± 0.21 ） % separately. The prevalence of hypoglycemia was 0.38/（ patient · year） , and no nocturnal hypoglycemia and serous hypoglycemia was reported. Body weight and body mass index were decreased compared with base line. Conclusions A single main mealtime bolus of glulisine,added to glargine and OADs proved to be a practicable regimen which can significantly improve HbAI c levels.