高比例预混胰岛素类似物与格列美脲联用治疗口服降糖药物治疗不佳2型糖尿病临床研究

Clinical study of premixed insulin analogues with high proportion combined with glimepirid on type 2 diabetic patients with poor glycemic control

目的探讨高比例预混胰岛素类似物与格列美脲联用治疗口服降糖药物治疗不佳2型糖尿病临床效果及安全性。方法选取口服降糖药物治疗不佳2型糖尿病300例,采用随机数字表法分为对照组和观察组,每组各150例;其中对照组患者给予清晨口服格列美脲联合睡前甘精胰岛素皮下注射治疗;观察组患者则给予清晨口服格列美脲联合睡前高比例预混胰岛素类似物(诺和锐30)皮下注射治疗;比较两组患者血糖控制总达标率,治疗前后空腹血糖(FBG),餐后2 h血糖(2hFBG),糖化血红蛋白(HbA1c),三酰甘油(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C),高密度脂蛋白胆固醇(HDL-C),血糖达标时间、低血糖发生率、体重增加量及胰岛素用量等。结果观察组患者血糖控制总达标率显著优于对照组,差异有显著性[93.33%vs84.67%,P<0.05];对照组和观察组患者治疗后FBG、2hFBG、HbA1c、TG、TC及LDL-C水平较治疗前均显著改善;其中观察组患者治疗后FBG、2hFBG及HbA1c水平改善程度显著优于对照组,差异有显著性(P<0.05);两组患者HDL-C水平治疗前后组间比较差异无显著性(P>0.05);同时观察组患者血糖达标时间、低血糖发生率,体重增加量及胰岛素用量均显著优于对照组,差异有显著性[(10.07±2.24)vs(13.32±3.10)d,2.67%vs12.67%,(18.29±4.54)vs(30.10±4.68)u,P<0.05]。结论高比例预混胰岛素类似物与格列美脲联用治疗口服降糖药物治疗不佳2型糖尿病可有效提高血糖控制效果,改善生化指标,降低低血糖发生风险。

[ Objective ] To investigate clinical effects and safety of premixed insulin analogues with high propor- tion combined with glimepirid on type 2 diabetic patients with poor glycemic control. [ Methods ] 300 patients with type 2 diabetic patients with poor glycemic control were chosen and randomly divided into two groups including control group（150 patients） with glimepirid orally treatment in the morning combined with insulin glarsin subetaneous injection treatment at bedtime and observation group （150 patients） with premixed insulin analogues with high proportion （novomix 50） orally treatment in the morning combined with insulin glarsin subctaneous injection treatment at bedtime; and the total compliance rate of blood glucose control, fasting blood glucose （FBG） and 2-hour postprandial blood glucose （2hPBG）, HbAlc, triglycefides （TG）, total cholesterol （TC）, low-density lipoprotein cholesterol （LDLC）, high-density lipoprotein cholesterol （HDL-C）, ：he compliance time of blood glucose, the incidence, body weight increasing amount and insulin dosage of hypoglyceaaia of both groups were compared. [ Results ] The total compli- ance rate of blood glucose control of observation group was significant better than control group [93.33% vs 84.67%, P 〈0.05]. The biochemical indexes of both groups after treatment was significant better than before treatment includ- ing FBG, 2hFBG, HbAlc, TG, TC and LDL-C（P 〈0.05）. The improving degree of biochemical indexes of observation group after treatment was significant better than control group including FBG, 2hFBG and HbAlc （P 〈0.05）.There was no significantly difference in HDL-C between 2 groups before and after treatment （P 〉0.05）. The compliance time of blood glucose, the incidence of hypoglycemia, body weight increasing amount and insulin dosage of observa- tion treatment group was significant better than cortrol group [（10.07±2.24） vs （13.32±3.10） d, 2.67% vs 12.67%, （18.29±4.54） vs （30.10±4.68） u, P 〈0.05]. [ Conehtsion] Premixed insulin analogues with high proportion combined with glimepirid on type 2 diabetic patients with po）r glycemic control can efficiently improve control effect of blood glucose and biochemical indexes, and reduce the risk of hypoglycemia.