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基础-餐时胰岛素治疗在2型糖尿病患者住院管理中的随机研究(RABBIT 2试验)

Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial).

作者信息

Umpierrez Guillermo E, Smiley Dawn, Zisman Ariel, Prieto Luz M, Palacio Andres, Ceron Miguel, Puig Alvaro, Mejia Roberto

机构信息

General Clinical Research Center, Emory University School of Medicine, Grady Health System, 49 Jesse Hill Jr. Dr., Atlanta, GA 30303, USA.

出版信息

Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.

Abstract

OBJECTIVE

We sought to study the optimal management of hyperglycemia in non-intensive care unit patients with type 2 diabetes, as few studies thus far have focused on the subject.

RESEARCH DESIGN AND METHODS

We conducted a prospective, multicenter, randomized trial to compare the efficacy and safety of a basal-bolus insulin regimen with that of sliding-scale regular insulin (SSI) in patients with type 2 diabetes. A total of 130 insulin-naive patients were randomized to receive glargine and glulisine (n = 65) or a standard SSI protocol (n = 65). Glargine was given once daily and glulisine before meals at a starting dose of 0.4 units x kg(-1) x day(-1) for blood glucose 140-200 mg/dl or 0.5 units x kg(-1) x day(-1) for blood glucose 201-400 mg/dl. SSI was given four times per day for blood glucose >140 mg/dl.

RESULTS

The mean admission blood glucose was 229 +/- 6 mg/dl and A1C 8.8 +/- 2%. A blood glucose target of <140 mg/dl was achieved in 66% of patients in the glargine and glulisine group and in 38% of those in the SSI group. The mean daily blood glucose between groups ranged from 23 to 58 mg/dl, with an overall blood glucose difference of 27 mg/dl (P < 0.01). Despite increasing insulin doses, 14% of patients treated with SSI remained with blood glucose >240 mg/dl. There were no differences in the rate of hypoglycemia or length of hospital stay.

CONCLUSIONS

Treatment with insulin glargine and glulisine resulted in significant improvement in glycemic control compared with that achieved with the use of SSI alone. Our study indicates that a basal-bolus insulin regimen is preferred over SSI in the management of non-critically ill, hospitalized patients with type 2 diabetes.

摘要

目的

鉴于目前很少有研究关注非重症监护病房的2型糖尿病患者高血糖的最佳管理,我们旨在对此展开研究。

研究设计与方法

我们进行了一项前瞻性、多中心、随机试验,比较基础-餐时胰岛素方案与常规胰岛素按血糖水平调整剂量给药(SSI)在2型糖尿病患者中的疗效和安全性。共有130例既往未使用过胰岛素的患者被随机分为两组,分别接受甘精胰岛素和门冬胰岛素(n = 65)或标准SSI方案(n = 65)。甘精胰岛素每日注射1次,门冬胰岛素在餐前注射,起始剂量为血糖140 - 200 mg/dl时0.4单位×kg⁻¹×天⁻¹,血糖201 - 400 mg/dl时0.5单位×kg⁻¹×天⁻¹。血糖>140 mg/dl时,SSI每日注射4次。

结果

平均入院血糖为229±6 mg/dl,糖化血红蛋白(A1C)为8.8±2%。甘精胰岛素和门冬胰岛素组66%的患者血糖目标达到<140 mg/dl,而SSI组这一比例为38%。两组间平均每日血糖相差23至58 mg/dl,总体血糖差异为27 mg/dl(P < 0.01)。尽管增加了胰岛素剂量,接受SSI治疗的患者中有14%的血糖仍>240 mg/dl。低血糖发生率和住院时间无差异。

结论

与单独使用SSI相比,甘精胰岛素和门冬胰岛素治疗能显著改善血糖控制。我们的研究表明,在治疗非危重症住院2型糖尿病患者时,基础-餐时胰岛素方案优于SSI。

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