2型糖尿病患者口服降糖药控制不佳时配伍相关药物的疗效与安全性

The Abilities and Associated Hypoglycemia Risks of Oral Therapy Added to Insulin Glargine or Human NPH Insulin in the Patients with T2DM

目的比较2型糖尿病患者口服降糖药控制不佳时加用甘精胰岛素或中效胰岛素(NPH)使HbAlc达到7%的疗效与安全性。方法在64例服用1种或2种口服降糖药但血糖控制不佳的2型糖尿病患者(HbAlc>8%)中随机加用一次甘精胰岛素或NPH,治疗12周后,使空腹血糖(FBG)达到≤5.6mmol/L,观察指标为FBG、糖化血红蛋白(HbAlc)、低血糖发生率和达到HbAlc≤7%,并且没有发生有记录的夜间低血糖的患者百分数。结果试验结束时甘精胰岛素组和NPH组的空腹血糖和HbAlc无统计学差异(P>0.05)。在HbAlc≤7%,且没有发生有记录的低血糖方面,甘精胰岛素组明显优于NPH组(P<0.05)。甘精胰岛素组的夜间低血糖发生率显著低于NPH组(P<0.05)。结论2型糖尿病口服降糖药控制不佳的患者加用甘精胰岛素,可使血糖达标并且低血糖发生率显著低于NPH。

OBJECTIVE To compare the abilities and associated hypoglycemia risks of oral therapy added to insulin glargine and human NPH insulin in the patients with type 2 diabetes mellitus （T2DM）to achieve HBA1C less than 7%. METHODS Sixty-four patients with inadequate glycemic control （HbA1c〉8%）on one or two oral agents were added to＇insulin glargine and human NPH insulin in a randomized in the patients with type 2 diabetes mellitus （T2DM） to achieve a target fasting plasma glucose （FPG） 〈5.6 mmol/L after 12 weeks. Outcome measures were FPG, HbA1C, hypoglycemia, and percentage of patients reaching HbA1C 7% without documented nocturnal hypoglycemia. RESULTS There were no difference in the levels of mean FPG and HbA1C at end point between glargine group and NPH group （P〉 0.05）.The numbers in the patients with HbA1C 〈7% and without documental nocturnal hypoglycemia in glargine group were higher than those in NPH group （P 〈0.05） . Rats of symptomatic hypoglycemia in glarglne group were significantly lower than that in NPH group （P〈 0.05）. CONCLUSION The numbers in the patients with HbA1c〈7% and without documental nocturnal hypoglycemia in glaxgine group were higher than those in NPH group in the patients with T2DM with inadequate glyeemic control on one or two oral agents.