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目的观察罗格列酮钠对血糖控制未达标的2型糖尿病(T2DM)合并与不合并非酒精性脂肪肝(NAFL)患者的降糖疗效和安全性。方法 2009年1月-2011年1月60例仅用磺脲类和二甲双胍治疗血糖控制未达标的T2DM患者,按合并和不合并NAFL分为观察组和对照组各30例,两组均在原口服降糖药基础上联合加用国产罗格列酮钠4 mg 1次/d,治疗共3个月,观察治疗前后的血糖、胰岛素、糖化血红蛋白(HbA1c)、体质量指数(BMI)、血脂、肝功、血压水平以及药物不良反应,并比较治疗后的血糖达标率。结果两组患者治疗后的空腹血糖(FPG)、餐后2 h血糖(2hPG)、HbA1c、空腹胰岛素、甘油三酯和极低密度脂蛋白胆固醇均较治疗前下降,高密度脂蛋白胆固醇较治疗前升高(P<0.05),而丙氨酸转氨酶、总胆固醇、低密度脂蛋白胆固醇及血压无明显变化(P>0.05),但观察组治疗后的FPG和2hPG均较对照组下降更明显(P<0.01),且血糖达标率为73.3%,显著高于对照组的46.7%(P<0.05),同时观察组餐后2 h胰岛素(2hINS)水平在治疗前后均明显高于对照组而且治疗后有显著下降(P<0.01),但对照组治疗后2hINS虽然也有下降但无统计学意义(P>0.05)。观察组治疗前后BMI无明显变化,但对照组治疗后BMI有明显的升高(P<0.05)。结论国产罗格列酮钠片对血糖控制未达标的T2DM合并和不合并NAFL患者均有进一步降低血糖、HbA1c以及改善血脂的作用,但对T2DM合并NAFL的患者的降糖疗效更显著,未见加重肝功能损坏,不良反应小,可作为此类患者联合用药的一种选择。
Objective To observe the anti-diabetic efficacy and safety of rosiglitazone in patients with non-compliance of non-alcoholic fatty liver disease (NAFL) with uncontrolled glycemic control of type 2 diabetes mellitus (T2DM). METHODS: From January 2009 to January 2011, 60 patients with T2DM who did not achieve glycemic control only were treated with sulfonylureas and metformin. The patients were divided into observation group and control group with or without NAFL, 30 patients in each group, On the basis of hypoglycemic agents combined with domestic sodium rosiglitazone 4 mg once a day for 3 months, the blood glucose, insulin, HbA1c, body mass index (BMI) Liver function, blood pressure and adverse drug reactions, and compare the blood glucose compliance rate after treatment. Results After treatment, fasting blood glucose (FPG), postprandial 2h blood glucose (2hPG), HbA1c, fasting insulin, triglyceride and very low density lipoprotein cholesterol decreased compared with before treatment, and high-density lipoprotein cholesterol (P <0.05), but there was no significant change in alanine aminotransferase, total cholesterol, low density lipoprotein cholesterol and blood pressure (P> 0.05), but FPG and 2hPG in the observation group decreased more significantly than those in the control group (P <0.01), and the rate of blood glucose compliance was 73.3%, which was significantly higher than that of the control group (46.7%, P <0.05). Meanwhile, the 2 h insulin levels at 2 h after meal in the observation group were significantly higher than those in the control group After treatment, there was a significant decrease (P <0.01), but there was no significant difference in the 2 h INS after treatment in the control group (P> 0.05). There was no significant change in BMI before and after treatment in the observation group, but the BMI in the control group was significantly higher after treatment (P <0.05). Conclusion Domestic rosiglitazone sodium tablets have the effect of lowering blood glucose, HbA1c and improving blood fat in patients with non-compliance of T2DM and non-compliance of NAFL. However, the effect of lowering blood glucose is more obvious in T2DM patients with NAFL Increased liver damage, adverse reactions, as a combination of such patients an option.