随机、双盲、安慰剂对照评价盐酸吡格列酮并用磺酰脲类药物治疗2型糖尿病的有效性和安全性

目的 评价盐酸吡格列酮30 mg与磺酰脲类药物并用治疗2型糖尿病的有效性和安全性。方法 采用多中心、随机、双盲和安慰剂平行对照的研究方法。236例使用稳定剂量磺酰脲类药物治疗至少30 d而血糖控制不佳(空腹血糖7.5～ 13.0 mmol/L，糖化血红蛋白7.0％～12.0％)的2型糖尿病患者随机分入吡格列酮30 mg组与安慰剂组，磺酰脲类药物种类和剂量不变，治疗随访共16周。结果 16周时，吡格列酮组空腹血糖下降(1.48±2.08) mmol/L，安慰剂组则上升(0.17±1.92) mmol/L(P ＜0.05)；吡格列酮组和安慰剂糖化血红蛋白分别下降(0.92±0.10)％和(0.28±0.11)％，空腹胰岛素下降(0.24±0.04) mU/L和(0.09±0.04) mU/L，稳态模型评价法计算的胰岛素抵抗指数下降1.42±2.90和0.46 ±3.52，TG平均下降0.36 mmol/L和0.14 mmol/L，HDL-C则平均上升0.17 mmol/L和0.05 mmol/L，两组间差异均有统计学意义(值均P＜0.05)。结论 为期16周的临床研究显示，2型糖尿病患者在单纯应用磺酰脲类血糖控制欠佳时加用吡格列酮30 mg/d，不仅可进一步改善血糖控制、增强胰岛素敏感性，还可降低TG、升高HDL-C水平，安全性和耐受性好。

A randomized, double blind, placebo-controlled, parallel and multicenter study to evaluate the safety and efficacy of pioglitazone with sulphonyurea in type 2 diabetic patients

Objective To evaluate the safety and efficacy of 30 mg pioglitazone hydrochloride combined with sulphonyurea in the treatment of type 2 diabetic patients.Methods A randomized, double blind, placebo-controlled, parallel group, multicenter study was performed.A total of 236 patients, who had fasting plasma glucose(FPG) 7.5-13.0 mmol/L and glycosylated hemoglobin A1c(HbA1 c) 7.0％ -12.0％,treated with stable dosage of a sulphonyurea for at least 30 days previously, were randomized to receive placebo or pioglitazone 30 mg once daily for 16 weeks.The sulphonyurea and dosage remained unchanged.Results The patients who had been treated with pioglitazone 30 mg showed significant decrease than that in the placebo group on the average from baseline in FPG [(1.48 ±2.08) mmol/L vs (-0.17 ± 1.92)mmol/L, P＜0.05], and in HbAlc [(0.92 ±0.10)％ vs (0.28 ±0.11)％, P＜0.05].Since fasting plasma insulin (Flns) levels decreased (0.24 ±0.04) mU/L and (0.09 ±0.04) mU/L in the two groups.The homeostatic model assessment insulin resistant (HOMA-IR) decreased 1.42 ± 2.90 and 0.46 ± 3.53 in two groups.The triglyceride level was decreased 0.36 mmol/L and 0.14 mmol/L, and the HDL-C level increased 0.17 mmol/L and 0.05 mmol/L in two groups.There were significant differences in two groups (all P ＜ 0.05).Conclusions The 16-week clinical study demonstrated that pioglitazone hydrochloride with a dosage of 30mg daily, could significantly improve the blood glucose control and enhance the insulin sensitivity, lower triglyceride and raise HDL-C level as an additional therapy to a stable-dose sulphonyurea in Chinese type 2 diabetic patients previously poorly controlled by single sulphonyurea therapy, and furthermore had good safety and compliance.