口服降糖药分别联合不同胰岛素类似物治疗血糖控制不佳2型糖尿病的临床研究

Clinical Study of the Combination of Oral Hypoglycemic Agents with Different Insulin Analogues for the Treatment of Type 2 Diabetes Mellitus with Poor Glycemic Control

目的比较二甲双胍分别联合地特胰岛素、双相门冬胰岛素30治疗单纯口服降糖药血糖控制不佳2型糖尿病(T2DM)的临床疗效与安全性。方法选取2014年8月—2016年12月无锡市第二人民医院收治的单纯口服降糖药血糖控制不佳T2DM患者112例为研究对象,采用随机数字表将患者分为A组57例、B组55例。所有患者停服除二甲双胍外所有降糖药,A组采用二甲双胍+地特胰岛素降糖方案,B组采用二甲双胍+双相门冬胰岛素30降糖方案,治疗12周后比较两组血糖指标、胰岛功能指标及药物不良反应。结果治疗期间,A、B组分别脱失2例、1例。治疗12周后,两组患者空腹血糖(FPG)、餐后2 h血糖(2 hPG)、糖化血红蛋白(HbA_(1c))比较,差异均无统计学意义(P>0.05);A组和B组治疗12周后FPG、2 hPG、HbA_(1c)较治疗前降低(P<0.05)。治疗12周后,两组患者FPG、2 hPG、HbA_(1c)达标率比较,差异均无统计学意义(P>0.05)。治疗12周后,两组患者稳态模型胰岛β细胞功能指数(HOMA-β)、稳态模型胰岛素抵抗指数(HOMA-IR)比较,差异均无统计学意义(P>0.05)。A组和B组治疗12周后HOMA-β较治疗前升高,HOMA-IR较治疗前降低(P<0.05)。A组患者胰岛素类似物用量为(24.96±3.57)U/d,B组患者胰岛素类似物用量为(25.18±3.85)U/d,差异无统计学意义(t=0.309,P=0.758)。治疗前及治疗12周后,两组患者体质指数(BMI)比较,差异均无统计学意义(P>0.05);两组患者治疗前与治疗12周后BMI比较,差异均无统计学意义(P>0.05)。治疗期间两组患者低血糖事件、转氨酶升高、头痛、胃肠功能紊乱发生率比较,差异均无统计学意义(P>0.05)。结论对单纯口服降糖药血糖控制不佳的T2DM患者,采用二甲双胍联合地特胰岛素或双相门冬胰岛素30均能在无明显体质量变化的基础上达到相似的降糖效果。

Objective To compare the clinical efficacy and safety of metformin in combination with insulin Detemir(IDet)and biphasic insulin aspart 30(BIAsp30)in the treatment of patients with type 2 diabetes mellitus(T2DM)and poor glycemic control when treated with oral hypoglycemic agents alone.Methods A total of 112 T2DM patients who were admitted to the Second People's Hospital of Wuxi from August 2014 to December 2016,with poor blood glucose control when treated with oral hypoglycemic agents alone were selected as the study subjects and grouped using a random number table into Group A(n=57)and Group B(n=55).All patients discontinued all hypoglycemic agents other than metformin.Group A received metformin+IDet hypoglycemic regimen,while Group B received metformin+BIAsp30 hypoglycemic regimen.After 12 weeks of treatment,blood glucose,pancreatic islet function,and adverse drug reactions were compared between the two groups.Results Excluding the dropouts in Group A(n=2)and B(n=1)during treatment,fasting plasma glucose(FPG),postprandial blood glucose(2 hPG)and glycosylated hemoglobin(HbA1c)were not significantly different between the two groups after 12 weeks treatment(P>0.05);FPG,2 hPG,and HbA1c decreased in Groups A and B(P<0.05),and no statistically significant difference was detected in terms of the compliance rates between the two groups(P>0.05).There was no significant difference in the homeostasis model assessment of isletβ-cell function(HOMA-β)and insulin resistance index(HOMA-IR)(P>0.05).HOMA-βin both groups increased,while HOMA-IR decreased compared with that before treatment(P<0.05).There was no significant difference in the following parameters:the dose of insulin analogue in Groups A and B,which was(24.96±3.57)U/d,and(25.18±3.85)U/d,respectively(t=0.309,P=0.758);intra-group body mass index(BMI)before and after 12 weeks of treatment(P>0.05);inter-group BMI before and after 12 weeks of treatment(P>0.05);the incidence of hypoglycemia,transaminase elevation,headache,and gastrointestinal dysfunction between the two groups during the treatment period(P>0.05).Conclusion In T2DM patients with poor glycemic control following administration of oral hypoglycemic agents alone,metformin in combination with either IDet or BIAsp30 can achieve a similar hypoglycemic effect without significant changes in body mass.