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一项针对曾接受曲格列酮治疗的2型糖尿病患者,比较吡格列酮或罗格列酮代谢效应的前瞻性随机对照研究。

A prospective, randomized comparison of the metabolic effects of pioglitazone or rosiglitazone in patients with type 2 diabetes who were previously treated with troglitazone.

作者信息

Khan Mehmood A, St Peter John V, Xue Jay L

机构信息

Division of Endocrinology, Mayo Clinic, Rochester, Minnesota, USA.

出版信息

Diabetes Care. 2002 Apr;25(4):708-11. doi: 10.2337/diacare.25.4.708.

DOI:10.2337/diacare.25.4.708
PMID:11919129
Abstract

OBJECTIVE

To characterize potential differences in glycemic control, plasma lipid level, and weight in a cohort of patients previously treated with troglitazone (TROG) who were switched to either pioglitazone or rosiglitazone.

RESEARCH DESIGN AND METHODS

After a 2-week washout from TROG, 186 patients were randomly assigned to receive either pioglitazone (PIO) or rosiglitazone (ROSI). Weight, HbA(1c), and fasting lipid profile were documented before discontinuing TROG and at 4 months after starting either pioglitazone or rosiglitazone. Secondarily, the effect of concurrent medications on study outcomes was assessed.

RESULTS

A total of 127 patients completed follow-up: 67 individuals in the PIO group (32 women, 35 men) and 60 individuals in the ROSI group (33 women, 27 men). There were no significant differences in gender mix, age, weight, fasting lipid profile, or HbA(1c) between the ROSI and PIO groups. After 4 months of randomized treatment, no change in HbA(1c) from baseline between or within groups was noted. Both groups experienced an equal and significant increase in weight from baseline of approximately 2.0 kg. Thiazolidinedione and HMG-CoA reductase inhibitor therapy had significant and independent effects on lipid profile (P < 0.005). Significant improvements in lipid profile were noted in the PIO group (P < 0.01), whereas none were detected with conversion to ROSI. Specifically, the PIO group experienced an average decrease in total cholesterol of approximately 20 mg/dl.

CONCLUSIONS

Differing effects on lipid profile were apparent after random conversion from TROG to either PIO or ROSI, despite similar weight increase and glycemic control. The clinical significance of these differences remains to be determined, and further comparative research is warranted.

摘要

目的

对一组曾接受曲格列酮(TROG)治疗后转而使用吡格列酮或罗格列酮的患者的血糖控制、血脂水平和体重方面的潜在差异进行特征描述。

研究设计与方法

在停用TROG 2周的洗脱期后,186例患者被随机分配接受吡格列酮(PIO)或罗格列酮(ROSI)治疗。在停用TROG前以及开始使用吡格列酮或罗格列酮4个月后记录体重、糖化血红蛋白(HbA1c)和空腹血脂情况。其次,评估同时使用的药物对研究结果的影响。

结果

共有127例患者完成随访:PIO组67例(女性32例,男性35例),ROSI组60例(女性33例,男性27例)。ROSI组和PIO组在性别构成、年龄、体重、空腹血脂情况或HbA1c方面无显著差异。随机治疗4个月后,组间和组内HbA1c与基线相比均无变化。两组体重均较基线水平显著且同等程度增加,约2.0千克。噻唑烷二酮类药物和HMG-CoA还原酶抑制剂治疗对血脂情况有显著且独立的影响(P<0.005)。PIO组血脂情况有显著改善(P<0.01),而转换为ROSI治疗则未检测到血脂改善。具体而言,PIO组总胆固醇平均降低约20mg/dl。

结论

从TROG随机转换为PIO或ROSI后,尽管体重增加和血糖控制情况相似,但对血脂情况的影响明显不同。这些差异的临床意义仍有待确定,有必要进行进一步的比较研究。

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