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2型糖尿病患者中甘精胰岛素与中效低精蛋白锌胰岛素睡前给药的比较:一项多中心、随机、平行组研究中每日一次注射胰岛素患者的亚组分析

A comparison of bedtime insulin glargine with bedtime neutral protamine hagedorn insulin in patients with type 2 diabetes: subgroup analysis of patients taking once-daily insulin in a multicenter, randomized, parallel group study.

作者信息

Fonseca Vivian, Bell David S, Berger Sheldon, Thomson Stephen, Mecca Thomas E

机构信息

Tulane University, 430 Tulane Avenue-SL53, New Orleans, LA 70112, USA.

出版信息

Am J Med Sci. 2004 Nov;328(5):274-80. doi: 10.1097/00000441-200411000-00007.

Abstract

BACKGROUND

Basal insulin is frequently administered once daily. This subgroup analysis of a multicenter, randomized, parallel study compared insulin glargine (Lantus Aventis Pharmaceuticals, Bridgewater, NJ) with neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes, evaluating only patients treated previously with once-daily NPH insulin.

METHODS

Patients received bedtime insulin glargine or NPH insulin, with preprandial regular insulin. One hundred patients (mean age, 57.9 years; mean glycohemoglobin, 8.4%; mean fasting blood glucose, 167 mg/dL) were treated for up to 28 weeks.

RESULTS

Patients treated with insulin glargine (n = 52) and NPH insulin (n = 48) achieved similar reductions from baseline in glycohemoglobin (-0.41% versus -0.46%) and fasting blood glucose (-22 mg/dL versus -22 mg/dL) at week 28. The proportion of patients reaching target fasting blood glucose (<120 mg/dL) at 28 weeks was 34.2% with insulin glargine and 24.4% with NPH insulin. Similar proportions of patients achieved glycohemoglobin less than 7% and less than 8% in both groups. Baseline and week-28 mean daily doses of insulin glargine (27.3 IU versus 36.4 IU) were similar to NPH insulin doses (25.5 IU versus 30.2 IU). However, significantly fewer patients reported one or more episodes of hypoglycemia with insulin glargine (46.2%) versus NPH insulin (60.4%; P < 0.05). Significantly fewer patients also reported one or more symptomatic episodes confirmed by blood glucose less than 50 mg/dL with insulin glargine (17.3%) versus NPH insulin (31.3%; P < 0.005).

CONCLUSION

Bedtime insulin glargine is as effective as bedtime NPH insulin in improving glycemic control, with significantly less hypoglycemia.

摘要

背景

基础胰岛素通常每日注射一次。这项多中心、随机、平行研究的亚组分析比较了甘精胰岛素(赛诺菲安万特制药公司,新泽西州布里奇沃特)与中性鱼精蛋白锌(NPH)胰岛素在2型糖尿病患者中的疗效,仅评估既往接受每日一次NPH胰岛素治疗的患者。

方法

患者在睡前接受甘精胰岛素或NPH胰岛素治疗,并在餐前使用常规胰岛素。100名患者(平均年龄57.9岁;平均糖化血红蛋白8.4%;平均空腹血糖167mg/dL)接受了长达28周的治疗。

结果

在第28周时,接受甘精胰岛素治疗的患者(n = 52)和接受NPH胰岛素治疗的患者(n = 48)糖化血红蛋白较基线的降幅相似(分别为-0.41%和-0.46%),空腹血糖降幅也相似(分别为-22mg/dL和-22mg/dL)。在第28周时,达到空腹血糖目标(<120mg/dL)的患者比例,甘精胰岛素组为34.2%,NPH胰岛素组为24.4%。两组中糖化血红蛋白低于7%和低于8%的患者比例相似。甘精胰岛素的基线和第28周平均每日剂量(27.3IU对36.4IU)与NPH胰岛素剂量(25.5IU对30.2IU)相似。然而,报告发生一次或多次低血糖事件的患者,使用甘精胰岛素的(46.2%)明显少于使用NPH胰岛素的(60.4%;P < 0.05)。报告发生一次或多次经血糖确认低于50mg/dL的症状性低血糖事件的患者,使用甘精胰岛素的(17.3%)也明显少于使用NPH胰岛素的(31.3%;P < 0.005)。

结论

睡前使用甘精胰岛素在改善血糖控制方面与睡前使用NPH胰岛素效果相当,但低血糖发生率显著更低。

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