罗格列酮对单用胰岛素控制血糖欠佳的2型糖尿病患者临床疗效观察

A CLINICAL TRIAL OF ROSIGLITAZONE THERAPY IN PATIENTS WITH INADEQUATELY CONTROLLED INSULIN-TREATED TYPE 2 DIABETES

目的:观察罗格列酮应用于单用胰岛素治疗血糖控制欠佳的2型糖尿病患者的疗效及安全性。方法:102例2型糖尿病患者,空腹血糖控制在7.8-13.9mmol/L范围内,随机分成两组:单用胰岛素治疗组(DM+INS组)50例。联合治疗组(DM+INS+RSG组)52例,在继续应用胰岛素治疗的基础上加服罗格列酮(Rosiglitazone RSG)4mg/d,共三个月。观测两组治疗前后空腹血糖(FPG)及餐后血糖(PPG)、糖化血红蛋白(HbA1C)、甘油三酯(TG)、胆固醇(TC)、高密度脂蛋白(HDL-C)、低密度脂蛋自(LDL-C)、体重指数(BMI)和胰岛素用量的改变。结果:DM+INS+RSG组与DM+INS组洽疗前FPG、PPG、HbA_1C、TC、TG、HDL-C、LDL-C和胰岛素用量无明显统计学差异。(P>0.05)。DM+INS+RSG组治疗后1个月和3个月FPG、PPG、HbA_1C均有明显的下降(P<0.05,P<0.01);胰岛素用量较治疗前减少,而DM+INS组治疗前后FPG、PIG、HbA_1C无明显的改变。Did+INS+RSG组TC、TG、HDL-C、LDL-C等各项指标较治疗前略有增加(P>0.05)。DM+INS+RSG组8例在治疗过程中出现双下肢轻度水肿,5例出现低血糖反应。结论:对单用胰岛素治疗血糖控制欠佳的2型糖尿病患者可加用胰岛素增敏剂罗格列酮治疗,可使血糖和糖化血红蛋白得以良好的控制,减少糖尿病患者每日胰岛素用量,临床毒副作用较小。

Objective： To observe the efficacy and safety of rosiglitasone when added to insulin in the treatment of type 2 diabetic patients who are not good controlled in plasma glucose on insulin monotherapy. Method： 102 type 2 diabetic patients with fasting plasma glucose were controlled between 7.8 - 13.9 mmol/L were randomized to insulin mondtherapy group （DM ＋ INS group） 50 cases and rosiglitazone added to insulin group （DM ＋ INS ＋ RSG group） 52 cases for 3 months treatment. The dosage of rosiglitazon was given 4 mg everyday in DM ＋ INS ＋ RSG group. The changes of laboratory datas including fasting plasma glucose （FPG）, postprandial plasmaglucose （PPG）, Hemoglobulin A1C （HbA1C）, eholesteral （TC）, triglyeeride （TG）, High density lipoprotein - eholeateral （FIDL - C）, Low density lipoprotein choleateral （LDL - C）, Body mass index （BMI） and dosages of insulin were measured before and after treatment in different groups. Results： There were not slgniflcandy difference in FPG, PPG, HbA1C, TC, TG, FIDL - C, LDL - C and dosages of insulin in the baseline between DM ＋ INS group and DM ＋ INS ＋ RSG group （p〉0. 05）. There were significantly decrease in FPG, PPG and HbA1C in the DM＋ INS＋ RSG group after 1 and 3 months treatment （P〈 0. 01, P〉 0. 01 ）. The dosages of insulin were also decreased in the DM ＋ INS ＋ RSG group at same time. there were not significantly difference in FPG, PPG and HbAIC between baseline and after 1 and 3 months treatment in the DM＋ INS group （P〉0. 05）. The datas of TC, TG, FIDL - C and LDL - C were slightly increased t in the DM ＋ INS ＋ RSG group after 1 and 3 months treatment （P〉0. 05）. Eight patients of type 2 diabetes had slight edema in the lower limbs and five patients had hypoglycemia in the DM＋ INS＋ RSG group. Conclusion： The addition of rceiglitazone to insulin treatment results in significantly improvement in glycemic control in the type 2 diabetic patients. The side effects of the rcsiglitazone were slight in the treatment.