双相门冬胰岛素与预混人胰岛素有效性和安全性对比研究

目的比较双相门冬胰岛素(诺和锐30)和预混人胰岛素(诺和灵30R)每日2次皮下注射治疗2型糖尿病(T2DM)的有效性和安全性。方法为期90 d的随机、开放性比较研究。114例T2DM患者被随机分为诺和锐30治疗组和诺和灵30R治疗组,采用每日早、晚餐前两次皮下注射联合二甲双胍0.25 g午餐后口服方案,观察两组患者8个时点血糖、糖化血红蛋白(HbA1c)、低血糖事件及其他不良事件的差异。结果诺和锐30治疗组三餐后血糖水平明显低于诺和灵30R治疗组(P<0.05);诺和锐30组低血糖发生次数低于诺和灵30R组,严重低血糖发生次数约为诺和灵30R组的一半;两组HbA1c指标、胰岛素用量及其他不良事件差异无统计学意义。结论T2DM患者采用早、晚餐前预混胰岛素皮下注射联合午餐后二甲双胍0.25 g口服方案治疗时,诺和锐30对餐后血糖控制更为满意,且低血糖事件发生率减少;两种治疗之间的总体血糖控制水平相似。

Comparison of effects and security of BIA 30 and BHI 30 on diabetes mellitus

Objective To compare the effect and security of BIAsp30 and BHI30 on type 2 diabetes mellitus(DM). Methods A 90-d open and random study was performed.All 114 patients with type 2 DM were randomly divided into 2 gouprs.One group was treated by BIAsp 30 and another by BHI30.Both drugs were respectively injected subcutaneously to the patients and together with oral metformin 0.25 g after lunch.Blood glucose at 8 time points,glycosylated hemoglobin and hypoglycemia were observed. Results The postprandial bood glucose was significantly lower in BIAsp30 group than in BHI30 one(P<0.05),and the frequency of hypoglycemia was lower in BIAsp30 group than in another one.And there was no difference between glycosylated hemoglobin and dosage of insulin. Conclusion BIAsp30 is surperior to BHI30,not only in controlling the postprandial blood glucose but also in reducing the incidence of hypoglycemia,while the total blood glucose control shows similar in both treatments.