盐酸吡格列酮治疗2型糖尿病有效性和安全性的临床观察

Efficacy and Safety of Pioglitazone in Type 2 Diabetes Patients

目的:评价盐酸吡格列酮联合磺脲类和二甲双胍治疗2型糖尿病患者的疗效和安全性。方法:口服磺脲类和二甲双胍药物稳定剂量1个月以上,而且空腹血糖≥7.5mmol·^(-1)的2型糖尿病患者101例,破随机双盲分入吡格列酮(每天30mg)治疗组(47例)或安慰剂联合磺脲类和二甲双胍对照组(46例),观察时间为12周。结果:吡格列酮治疗组在降低HbAlc、空腹和餐后2h血糖,都较对照组显著有效(P<0.05)。12周后,吡格列酮组空腹血糖平均下降1.6mmol·L^(-1),餐后2h血糖下降2.1mmol·L^(-1),HbAlc水平下降1.1％。吡格列酮联合磺脲类和二甲双胍治疗可明显降低甘油三酯水平(29％),同时升高HDL-C水平(11％),总胆固醇和LDL-C水平亦有降低。吡格列酮耐受性良好,药物不良反应发生率与对照组无明显差异。结论:吡格列酮联合磺脲类和二甲双胍治疗2型糖尿病可明显改善HbAlC水平和空腹、餐后2h血糖,同时对本文所观察的脂代谢指标有改善作用。

OBJECTIVE: To assess the efficacy and safety of pioglitazone in combination with a sulfonylurea and metformin in patients with type 2 diabetes mellitus. METHODS: This 12-weeks, double-blind study included 101 patients on a stable regimen of a sulfonylurea and metformin for ≥ 30 days and with fasting plasma glucose level≥7.5mmol·L-1. Patients were randomly assigned to receive once daily pioglitazone 30 mg or placebo + sulfonylurea and metformin. RESULTS: Patients receving 30mg pioglitazone +sulfonylurea and metformin had significant (P < 0.05) decreases from baseline in HbAlc( 1.1%) and fasting plasma glucose ( 1.6mmmol·L-1) and 2h postprandial plasma glucose level ( 2.1 mmol·L-1) compared with patients treated with placebo +sulfonylurea and metformin .The pioglitazone +sulfonylurea and metformin had significant decreases in triglyceride levels (29%) and increases in high-density lipoprotein cholesterol levels (11%) compared with placebo +sulfonylurea and metformin. There were statistically significant decreases in low-density lipoprotein cholesterol and total cholesterol levels.The rate of adverse events were similar in both groups. CONCLUSION: In patients with type 2 diabetes, pioglitazone plus sulfonylurea and metformin significantly improves HbA1c and fasting plasma glucose and 2h postprandial plasma glucose levels with beneficial effects on all lipid variables of this observations.