摘要
目的:以二甲双胍为对照,评价盐酸吡格列酮治疗2型糖尿病的疗效和安全性。方法:采用多中心、随机、双盲双模拟、平行对照的试验设计,在5个中心共收集227例2型糖尿病病人,分为吡格列酮组（113例,服用盐酸吡格列酮30mg,每日1次）,和二甲双胍组（114例,服用盐酸二甲双胍250mg,每日2次）,治疗期12周。结果:用药12周后,与基础值相比,吡格列酮组空腹血糖下降1.42±1.93mmol.L-1（13.41±18.65％）,餐后2h血糖下降4.42±3.96mmol.L-1（26.94％±21.32％）,糖化血红蛋白下降0.80％±1.57％;二甲双胍组,空腹血糖下降1.62±2.17mmol·L（15.45±20.13％）,餐后2h血糖下降值3.89±3.75mmol·L-1（24.27％±21.54％）,糖化血红蛋白下降0.89％±1.39％。两组血糖和糖化血红蛋白下 降值与用药前比较均有显著性差异,但两组间比较无显著性差异。用药12周 后,吡格列酮组,降低空腹血糖显效率40.66％,有效率75.82％,降低餐后2h 血糖显效率51.38％,有效率86.24％;二甲双胍组,降低空腹血糖显效率53.85％, 有效率82.42％,降低餐后2h血糖显效率46.23％,有效率77.36％。两组间比较 显效率和有效性均无统计学意义。两组药物不良反应发生率相似,未出现严重 肝功能异常病例。结论:吡格列酮可有效地降低2型糖尿病病人的空腹血糖、餐 ?
OBJECTIVE: To evaluate the efficacy and safety of pioglitazone hydrochloride in the treatment of type 2diabetes mellitus patients, a double-blind double-dummy metformin-controlled trial was carried out. METHODS:A randomized, double-blind, metformin-controlled, and multicenter clinical trial was conducted. A total of 227 patients with type 2 diabetes mellitus were enrolled in this study, in which 113 patients received pioglitazone 30mg once daily, and 114 patients received metfbrmin 250mg b.i.d, for 12 weeks. RESULTS:Comparing to the baseline, the fasting blood glucose (FBG), 2h postprandial blood glucose (P2hBG) and HbA1C levels in tow groups were significantly reduced after 12-week treatment (P<0.01). In pioglitazone group, the mean reductions of FBG, P2hBG and HbA1C levels were 1.42±1.93mmol.L-1 (13.41 ±18.65%), 4.42±3.96mmol.L-1(26.94±21.32%), 0.80±1.57% respectively, the efficacy rate of reduction of FBG and P2hBG were 75.82% and 86.24%. In metformin group, the mean reductions of FBG, P2hBG and HbA1C levels were 1.62±2.17mmol. L-1( 15.45±20.13%), 3.89±3.75mmol.L-1(24.27±21.54%), 0.89±1.39% respectively, the efficacy rate of reduction of FBG and 2hPBG were 82.42%,77.36%.,The differencesin reductions of FBG, P2hBG and HbA1C level between the groups were not statistically significant. The incidence of adverse effects in tow groups was similar. Hepatic function did not significantly change after treatment. CONCLUSION: This result provides an efficacy in glycemic control and a safety profile of pioglitazone in the treatment of type 2 diabetes mellitus.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2002年第3期167-170,共4页
The Chinese Journal of Clinical Pharmacology
关键词
盐酸吡格列酮
治疗
2型糖尿病
疗效
安全性
diabetes mellitus,non-insulin dependent
pioglitazone hydrochloride
metformin
