盐酸罗格列酮片治疗2型糖尿病的疗效及安全性

目的：评价盐酸罗格列酮片治疗2型糖尿病的有效性和安全性，并与马来酸罗格列酮片进行比较。方法：132例2型糖尿病病人被随机分为两组，对照组66例，口服马来酸罗格列酮片，每次4mg，每日1次；试验组66例，口服盐酸罗格列酮片，每次4mg，每日1次。经两周冲洗期后进入治疗期，疗程16周。分别于治疗前与治疗后测定病人的空腹血糖（FPG）、餐后2h血糖、糖化血红蛋白（GHb）、空腹胰岛素及C肽水平。结果：本研究共有126例病人完成了试验，其中对照组64例，试验组62例。经过治疗，试验组和对照组FPG、餐后2h血糖、GHb和空腹胰岛素水平均下降，与基线值比较差别均有统计学意义（P〈0．01），试验组和对照组之间比较差异无统计学意义（P〉0．05）；两组C肽浓度均下降，但与基线值比较差别无统计学意义。两组治疗前后血常规、血生化（包括肝功能）及心电图各项观察指标均无明显改变。结论：盐酸罗格列酮片能有效地降低餐后血糖和FPG以及GHb水平，且病人耐受性好，安全性高。

Efficacy and safety of rosiglitazone hydrochloride in the treatment of patients with type 2 diabetes mellitus

Objective：To evaluate the clinical efficacy and safety of rosiglitazone hydrochloride in the treatment of patients with type 2 diabetes mellitus, Methods： One hundred and thirty two patients with type 2 diabetes mellitus who met 1999 WHO diagnostic criteria of diabetes mellitus were assigned to receive rosiglitazone hydrochloride （4 mg/d） or rosiglitazone maleate （4 mg/d） in a randomized, double blind, double dummy, muhicentre clinical trial. The trial consisted of a 2-week washing period and a 16-week treatment period. The levels of fasting and postprandial plasma glucose, glycosylated hemoglobin, fasting insulin and C peptide of the patients in two groups were determined before and after the treatment, Results： One hundred and twenty-six patients completed the trial （64 patients in control group and 62 patients in treatment group）, After the treatment, the levels of fasting and postprandial plasma glucose,glycosylated hemoglobin, fasting insulin were decreased significantly compared with those of the baseline （P〈0.01 ）. However, the differences were not statistically significant between the two groups （P〉0. 05）. The levels of C peptide in two groups were also decreased after 16-week treatment, but the differences were not significant compared with the baseline, The results of blood routine and biochemical examinations （including liver function） and electrocardiogram did not change significantly. Conclusion： Once-daily regimen with rosiglitazone hydrocbloride provides effective control of plasma glucose levels for the patients with type 2 diabetes mellitus. Compared with rosiglitazone maleate, rosiglitazone hydrochloride is equally safe and effective .