国产重组甘精胰岛素注射液和来得时治疗糖尿病的疗效和安全性比较

摘要

Objiective To compare the therapeutic effects and safety of domestic recombinant insulin glargine injection and Lantus in treatment of diabetes.Metnods56 patients with diabetes from December 2011 to August 2012 in our hospital were divided randomly into a domestic recombinant insulin glargine injection group(recombinant insulin glargine injection from United Laboratories subcutaneous injection once daily at 22:00-23:00 bedtime)and a Lantus group(Lantus subcutaneous injection once daily at 22:00-23:00 bedtime). Short-acting insulin or oral hypoglycemic agents which were used before the study would remain unchanged at all stages.After 16 weeks treatment,comparisons were conducted between two groups and between before and after treatment in glycated hemoglobin A1c(HbA1c),fasting plasma glucose(FPG),hypoglycemia,insulin dose at the end of treatment,body weight,liver function and renal function.Result HbA1c and FPG of patients in two groups reduced markedly after 16 weeks of treatment(P<0.05).There was no statistical difference between two groups in the same indexs(HbA1c before treatment,HbA1c after treatment,FPG before treatment,FPG after treatment)(P>0.05).And no statistical difference between two groups in incidence of hypoglycemia(P>0.05)and insulin dose at the end of treatment(P>0.05)has been found. There was no statistical difference between before and after treatment in each group respectively in liver function and renal function(P>0.05). In domestic recombinant insulin glargine injection group,patient's body weight increased than before treatment(P<0.05).In Lantus group,patient's body weight has the same trend but no statistical change between before and after treatment(P>0.05).When patient's body weight(whether before or after treatment)was compared between two groups respectively,no statistical difference has been found(P>0.05).ConclusionDomestic recombinant insulin glargine injection and Lantus can both effectively control blood glucose and prevent hypoglycemia. Domestic recombinant insulin glargine injection is not inferior to Lantus in therapeutic effects and safety.%目的：比较国产重组甘精胰岛素注射液和来得时治疗糖尿病的有效性和安全性。方法本资料就诊的糖尿病患者56例，随机分为国产重组甘精胰岛素组（22：00-23：00睡前皮下注射）与来得时组（22：00-23：00睡前皮下注射），两组患者入组前使用的短效胰岛素或口服降糖药整个试验过程保持不变。治疗16周后比较两组患者糖化血红蛋白（HbA1c）、空腹血糖（FPG）、低血糖发生率、治疗结束时胰岛素剂量、体重及肝肾功能。结果治疗16周后，两组患者的HbA1c、FPG均较治疗前有明显下降（P<0.05）；两组组间分别比较治疗前及治疗结束时的HbA1c、FPG差异均无统计学意义（P>0.05）；两组间低血糖发生率、治疗结束时两组胰岛素剂量及治疗前后两组组内比较患者肝肾功能差异均无统计学意义（P>0.05）；国产重组甘精胰岛素组治疗后体重增加（P<0.05），治疗前后来得时组体重虽有增加趋势，但无统计学差异（P>0.05）；两组组间分别比较患者治疗前后体重差异均无统计学意义（P>0.05）。结论国产重组甘精胰岛素与来得时均能有效控制血糖，避免低血糖发生。国产重组甘精胰岛素在治疗糖尿病的有效性和安全性方面与来得时相似。