口服胰岛素肠溶胶丸治疗2型糖尿病有效性和安全性的多中心临床观察

目的评价胰岛素肠溶胶丸降糖疗效，并与中效胰岛素注射液进行比较。方法采用多中心、随机、开放、平行对照临床试验，将260名2型糖尿病患者随机分为对照组（n=125）和试验组（n=135），分别于每日早、晚餐前1h给予皮下注射中效胰岛素注射液和口服胰岛素肠溶胶丸，共12周。结果胰岛素肠溶胶丸能显著降低2型糖尿病患者的糖化血红蛋白（HbAlc）及空腹和餐后2h血糖，HbAlc平均下降0．98％。以美国糖尿病学会（HbAlc≤7．0％）和国际糖尿病联盟（HbAlc≤6．5％）推荐的HbAlc达标标准判读，试验组的达标率分别为38．9％和21．4％，与对照组的45．1％和30．2％相比差异均无统计学意义（P=0．323和P=0．109）。两组患者的不良反应发生率差异无统计学意义（P=0．618），试验组患者的治疗满意度评分明显高于对照组患者（P=0．000）。结论胰岛素肠溶胶丸具有与中效胰岛素注射液相近的降糖疗效和安全性，且使用满意度更高。

A multi-center study on clinical efficacy and safety of insulin enteric-coated soft capsules in patients with type 2 diabetes mellitus

Objective To evaluate the clinical efficacy and safety of insulin enteric-coated soft capsules in patients with type 2 diabetes mellitus. Methods Totally 260 patients were enrolled in this multi-center,randomized, open, parallel-controlled clinical trial. Patients were orally administered with the capsule (capsule group, n = 135) or subcutaneously injected with insulin (control group, n = 125)one hour before the breakfast and supper time for 12 weeks. Results In the capsule group, the glyeosylated hemoglobin A1 c (HbA1 c)and fasting/postprandial blood glucoses were significantly decreased. In terms of the proportions of subjects achieving HbA1c goals using American Diabetes Association standard (HbA1c ≤7.0%)and International Diabetes Federation standard (HbA1c≤6.5%), they were 38.9% and 21.4% in capsule group and were 45.1% and 30. 2% in control group (P = 0. 323; P = 0. 109). The incidences of adverse reactions were not significantly different between these two groups (P = 0. 618). The satisfaction score was significantly higher in capsule group than in control group (P = 0. 000). Conclusion The insulin enteric-coated soft capsule has similar effectiveness and safety with insulin injections, and meanwhile is more popular among subjects.