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目的 评价盐酸吡格列酮治疗2型糖尿病的有效性及安全性。方法 用多中心随机双盲平行对照方法,将已合用磺脲类和双胍类药物的2型糖尿病患者随机分为2组:试验组口服吡格列酮,每日30mg;对照组服用安慰剂。各118例,疗程12周。结果 试验组空腹血糖、餐后2h血糖有明显下降(P<0. 01);糖化血红蛋白2组均有下降,试验组为-1. 06%,对照组为-0. 51%,均P<0. 01。2组胰岛素水平均无明显变化。治疗后,试验组高密度脂蛋白胆固醇升高了0. 11mmol·L-1 (P<0. 01),低密度脂蛋白胆固醇下降了0. 21mmol·L-1(P<0. 01),血压下降有统计学意义(P<0. 01),体重指数升高了0. 36 (P<0. 01)。试验组中,仅1例因中度肝功能异常退出试验,水肿较常见,程度轻。其他不良事件发生率2组相近。结论 口服降糖药后血糖控制不佳的2型糖尿病患者,加用盐酸吡格列酮30mg,可显著降低血糖,提高胰岛素敏感性,改善高血压状态,病人耐受性较好。
Objective To evaluate the efficacy and safety of pioglitazone in the treatment of type 2 diabetes. Methods A multicenter, randomized, double-blind, parallel-controlled trial of type 2 diabetes mellitus with sulfonylureas and biguanides was randomly divided into two groups: the experimental group received pioglitazone 30 mg daily; the control group received placebo. 118 cases each for 12 weeks. Results The fasting blood glucose in the experimental group was significantly lower than that in the 2h postprandial blood glucose (P <0.01), while the HbA1c decreased in both groups (-0.06% in the test group and -0.51% in the control group, P < 0. 01.2 insulin group no significant changes in the level. After treatment, the high-density lipoprotein cholesterol in the experimental group was increased by 0. 11 mmol·L-1 (P <0.01) and the low-density lipoprotein cholesterol by 0. 21 mmol·L-1 (P <0.01) Blood pressure decreased statistically significant (P <0.01), body mass index increased 0.36 (P <0.01). In the test group, only 1 patient exited the test due to abnormal liver function. Edema was common and mild. Other adverse events were similar in 2 groups. Conclusion Patients with type 2 diabetes mellitus after oral hypoglycemic agents with poorly controlled blood glucose, plus pioglitazone hydrochloride 30mg, can significantly lower blood glucose, improve insulin sensitivity and improve the state of hypertension, the patient tolerance is better.