【摘要】 目的:初步评价国产精蛋白锌重组赖脯胰岛素混合注射液（25R）治疗糖尿病的有效性和安全性。方法:本研究为多中心、随机、开放和阳性药物[进口精蛋白锌重组赖脯胰岛素混合注射液（25R）]平行对照的Ⅲ期临床试验,包括2周的导入期和12周的治疗期。在15个研究中心预计入选514例糖尿病患者,以3∶1的比例随机分配至国产组（386例）和进口组（128例）接受治疗。比较2组患者的糖化血红蛋白（HbA₁c）、空腹血糖（FPG）及餐后2 h血糖（2 hPG）水平和低血糖事件发生情况。结果:与基线水平比较,治疗12周后国产组、进口组患者的HbA₁c水平分别降低0.96%、0.82%,FPG水平分别降低1.74、1.94 mmol/L,2 hPG水平分别降低4.43、4.04 mmol/L,两组患者治疗前后上述指标水平的差异均有统计学意义（P<0.05）;但两组间比较,差异均无统计学意义（P>0.05）。国产组、进口组患者低血糖事件发生率分别为32.29%（124/384）、35.71%（45/126）,不良事件发生率分别为27.34%（105/384）、23.02%（29/126）,差异均无统计学意义（P>0.05）。结论:国产精蛋白锌重组赖脯胰岛素混合注射液（25R）治疗糖尿病的有效性非劣效于进口精蛋白锌重组赖脯胰岛素混合注射液（25R）,且具有良好的安全性。更多还原

【Abstract】 OBJECTIVE: To preliminarily evaluate the efficacy and safety of domestic mixed protamine zinc recombination human insulin lispro injection（25 R） in treatment of diabetes. METHODS: This study was a phase Ⅲ parallel-controlled trial of a multicenter, randomized, open and positive drug [imported mixed protamine zinc recombination human insulin lispro injection（25 R）], including a 2-week lead-in period and a 12-week treatment period. A total of 514 diabetic patients from 15 research centers were selected and randomly assigned to domestic group（386 cases） and import group（128 cases） with a ratio of 3∶1. Levels of glycated hemoglobin（HbA₁c）, fasting plasma glucose（FPG）, postprandial 2 h plasma glucose（2 hPG）, and incidences of hypoglycemic events were compared between two groups. RESULTS: Compared with the baseline level, the HbA₁c levels of the domestic and imported groups had respectively decreased by 0.96% and 0.82% after 12-week treatment, the FPG levels had respectively decreased by 1.74 and 1.94 mmol/L, the 2 hPG levels had respectively decreased by 4.43 and 4.04 mmol/L, with statistically significant differences（P<0.05）; however, there was no statistical significance in difference between the two groups（P>0.05）. The incidences of hypoglycemic events in domestic and imported groups were respectively 32.29%（124/384） and 35.71%（45/126）, with the incidence of adverse events were respectively 27.34%（105/384）and 23.02%（29/126）, the differences had no statistical significance（P>0.05）. CONCLUSIONS: The efficacy of domestic mixed protamine zinc recombination human insulin lispro injection（25 R） in treatment of diabetes is not inferior to that of the imported mixed protamine zinc recombination human insulin lispro injection（25 R）, while it has good safety.更多还原