曲格列酮对胰岛素治疗的II型糖尿病患者的作用。曲格列酮与外源性胰岛素研究组。

Effect of troglitazone in insulin-treated patients with type II diabetes mellitus. Troglitazone and Exogenous Insulin Study Group.

作者信息

Schwartz S, Raskin P, Fonseca V, Graveline J F

机构信息

Diabetes and Glandular Diseases Clinic, San Antonio, Tex., USA.

出版信息

N Engl J Med. 1998 Mar 26;338(13):861-6. doi: 10.1056/NEJM199803263381302.

DOI:10.1056/NEJM199803263381302

PMID:9516220

Abstract

BACKGROUND

Troglitazone is a new oral antidiabetic drug that increases the sensitivity of peripheral tissues to insulin. It may therefore increase the efficacy of exogenous insulin in patients with insulin-resistant diabetes mellitus.

METHODS

We studied the effect of troglitazone or placebo in 350 patients with poorly controlled non-insulin-dependent (type 2) diabetes mellitus (glycosylated hemoglobin values, 8 to 12 percent; normal, 4.3 to 6.1 percent) despite therapy with at least 30 U of insulin daily. The patients were randomly assigned to receive 200 mg of troglitazone (116 patients), 600 mg of troglitazone (116 patients), or placebo (118 patients) daily for 26 weeks. Insulin doses were not increased and were reduced only to prevent hypoglycemia. Glycosylated hemoglobin, serum glucose while fasting, serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides were measured 5 times during an 8-week base-line period and 10 times during the 26-week treatment period. Daily insulin doses were recorded during both periods.

RESULTS

Ninety percent of the patients completed the study. The adjusted mean glycosylated hemoglobin values decreased by 0.8 and 1.4 percentage points, respectively, in the group given 200 mg of troglitazone and the group given 600 mg of troglitazone, and fasting serum glucose concentrations decreased by 35 and 49 mg per deciliter (1.9 and 2.7 mmol per liter), respectively, despite decreases in the insulin dose of 11 percent and 29 percent (P<0.001 for all comparisons with the placebo group). Serum total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol concentrations increased slightly and serum triglyceride concentrations decreased slightly in the troglitazone-treated patients.

CONCLUSIONS

When given in conjunction with insulin, troglitazone improves glycemic control in patients with type 2 diabetes mellitus.

摘要

背景

曲格列酮是一种新型口服抗糖尿病药物，可增加外周组织对胰岛素的敏感性。因此，它可能会提高胰岛素抵抗型糖尿病患者外源性胰岛素的疗效。

方法

我们研究了曲格列酮或安慰剂对350例非胰岛素依赖型（2型）糖尿病控制不佳患者的影响，这些患者尽管每天使用至少30单位胰岛素治疗，但糖化血红蛋白值仍为8%至12%（正常为4.3%至6.1%）。患者被随机分配，每天接受200毫克曲格列酮（116例患者）、600毫克曲格列酮（116例患者）或安慰剂（118例患者）治疗，为期26周。胰岛素剂量不增加，仅在预防低血糖时减少。在8周的基线期测量糖化血红蛋白、空腹血清葡萄糖、血清总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇和甘油三酯5次，在26周的治疗期测量10次。两个时期均记录每日胰岛素剂量。

结果

90%的患者完成了研究。给予200毫克曲格列酮的组和给予600毫克曲格列酮的组调整后的平均糖化血红蛋白值分别下降了0.8和1.4个百分点，空腹血清葡萄糖浓度分别下降了35和49毫克/分升（1.9和2.7毫摩尔/升），尽管胰岛素剂量分别下降了11%和29%（与安慰剂组的所有比较P<0.001）。曲格列酮治疗的患者血清总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇浓度略有升高，血清甘油三酯浓度略有下降。