罗格列酮钠对2型糖尿病合并与不合并非酒精性脂肪肝患者疗效和安全性的比较

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。

The Comparison of Efficacy and Safety of Rosiglitazone Sodium on Type 2 Diabetes with or without Non-alcoholic Fatty Liver Disease

Objective To observe the effects and security of domestic rosiglitazone sodium in type 2 diabetic patients which inadequately controlled blood glucose accompanied with or without non-alcoholic fatty liver disease(NAFL). Methods Between January 2009 and January 2011,60 type 2 diabetic patients with uncontrolled blood glucose were randomly divided into observation group(with NAFL) and control group(without NAFL).Sulfonylurea plus metformin were used in both groups before the trial.The patients in both group received domestic rosiglitazone sodium for 3 months in addition to oral antihyperglycemia drugs.The level of fasting plasma glucose(FPG),postprandial 2 hours plasma glucose(2hPG),insulin,plasma lipid,blood pressure,liver function,and side effects of rosiglitazone sodium were evaluated before and after the trial respectively.The proportion of the blood glucose achieving the target in both groups at the end of treatment were compared.Results FPG,2hPG,HbA1c,fasting insulin,triglyceride and very low density lipoproteincholesterol reduced markedly in both groups after treatment,whereas high density lipoprotein cholesterol increased significantly(P < 0.05).Alanine aminotransferase,total cholesterol,low density lipoprotein-cholesterol and blood pressure showed no significant alteration(P > 0.05).But FPG and 2hPG in observation group decreased obviously compared with that in control group after treatment(P < 0.01).Postprandial 2 hours insulin(2hINS) in observation group was higher than that in control group before and after the trial respectively,meanwhile 2hINS in observation group decreased significantly at the end of the trial(P < 0.01).2hINS in control group decreased but showed no statistical significance(P > 0.05). BMI increased significantly in control group(P < 0.05) after treatment whereas there was no change in observation group. Conclusion Domestic rosiglitazone sodium tablets is effective on controlling blood glucose,HbA1c and may improveplasma lipid on type 2 diabetic patients with poorly controlled blood glucose whether accompanied with NAFL.