马来酸罗格列酮对2型糖尿病患者的长期疗效与安全性的观察

目的观察罗格列酮对2型糖尿病（T2DM）患者的长期疗效及安全性。方法采用自身治疗前后对照的方法，42例合用磺脲类、双胍类和α糖苷酶抑制剂药物治疗3个月以上血糖控制不良的T2DM患者加服马来酸罗格列酮，随访36个月，观察治疗前后血糖、HbA1c、FIns、HOMAIR、ISI、血清高敏C反应蛋白（hsC-RP）、Hb、谷丙转氨酶（GPT）、谷草转氨酶（GOT）、谷氨酰转移酶（γ-GT）等的变化。结果马来酸罗格列酮治疗组FPG、2hPG、HbA1c、FIns、hsCRP均较治疗前明显下降（P〈0．01），且与时间成正比，约治疗9个月后疗效趋于稳定，GPT、GOT、γ-GT较治疗前明显下降（P〈0．05）；所见的不良反应为下肢水肿，发生率为4．8％，经对症处理后消失。结论马来酸罗格列酮能有效降低长期口服降糖药物控制不佳的T2DM患者的血糖水平，对因脂肪肝而致的肝脏酶谱的增高有治疗作用，有良好的安全性。

Long-term efficacy and safety of rosiglitazone maleate in type 2 diabetic patients with inefficacy of sulfonylurea,metformin and acarbose

Objective To evaluate the efficacy and safety of rosiglitazone in type 2 diabetic patients with inefficacy of sulfonylurea,metformin and acarbose. Methods The therapeutic effects before and 3,6,9,12,24,36 months after rosiglitazone 4 mg/d were compared in 42 type 2 diabetic patients with the inefficacy of sulfonylurea,metformin and acarbose treatment for at least 3 month. Clinical variables included blood glucose,HbA1c, fasting insulin (FIns),insulin sensitive index (ISI),insulin resistance index (IRI),high sensitivity C-reactive protein (hsCRP), liver and renal functions. Results Compared with pre-treatment values, the levels of FPG, PPG, FIns, PIns, IRI, hsCRP and HbA1c were decreased, but ISI increased significantly in treatment group.Two cases (4.8%) had mild edema in the lower extremity, and diminished gradually with spironolactone treatment.No hypoglycemia and liver damage occurred. Conclusion The long-term addition of rosiglitazone maleate to the treatment of type 2 diabetic patients with the inefficacy of sulfonylurea, metformin and acarbose treatments is quite effective and safe.