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目的评价在口服降糖药二甲双胍的基础上餐前皮下注射重组人胰高血糖素样肽-1(rhGLP-1)治疗2型糖尿病的有效性和安全性。方法在随机、双盲、安慰剂对照的临床试验中,选取42例二甲双胍单药治疗的2型糖尿病患者,随机分为观察组和对照组,每组21例。在口服原剂量二甲双胍的基础上分别接受rhGLP-1 0.2 mg(观察组)或安慰剂(对照组)三餐前皮下注射治疗,随访12周,观察空腹血糖、餐后2 h血糖和糖化血红蛋白(HbA1c)等有效性指标及低血糖、不良反应和肝肾功能等安全性指标。结果观察组治疗后HbA1c、空腹及餐后血糖水平较前明显下降(P<0.05),且较对照组下降更为显著(P<0.05)。两组治疗后体质量指数均显著下降(P<0.05),但组间比较无统计学差异(P>0.05);观察组体质量指数下降程度与基线值呈正相关(P<0.01)。观察组和对照组均无确切证据的低血糖发生,两组间胃肠道不良反应发生率无统计学差异(P>0.05)。结论在口服二甲双胍的基础上给予rhGLP-1三餐前皮下注射治疗可有效降低2型糖尿病患者的空腹及餐后血糖,而不增加低血糖及其他不良事件的发生率。
Objective To evaluate the efficacy and safety of oral administration of recombinant human glucagon-like peptide-1 (rhGLP-1) on type 2 diabetes mellitus on the basis of oral hypoglycemic agents metformin. Methods In a randomized, double-blind, placebo-controlled clinical trial, 42 patients with type 2 diabetes mellitus treated with metformin monotherapy were randomly divided into observation and control groups, 21 in each. On the basis of oral administration of metformin, rhGLP-1 0.2 mg (observation group) or placebo (control group) were given subcutaneous injections three times before treatment. After 12 weeks of follow-up, fasting blood glucose, postprandial blood glucose 2 h and HbA1c HbA1c) and other indicators of effectiveness and hypoglycemia, adverse reactions and liver and kidney function and other safety indicators. Results The HbA1c, fasting and postprandial blood glucose levels in the observation group were significantly lower than those in the control group (P <0.05), and were significantly lower than those in the control group (P <0.05). After treatment, the body mass index decreased significantly (P <0.05), but there was no significant difference between the two groups (P> 0.05). The decrease of body mass index in the observation group was positively correlated with the baseline value (P <0.01). There was no definite evidence of hypoglycaemia in the observation group and the control group. There was no significant difference in the incidence of gastrointestinal adverse reactions between the two groups (P> 0.05). Conclusions Administration of rhGLP-1 subcutaneously three times before meal on the basis of oral metformin can effectively reduce the fasting and postprandial blood glucose in type 2 diabetic patients without increasing the incidence of hypoglycemia and other adverse events.