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地特胰岛素与甘精胰岛素在2型糖尿病住院患者中的疗效和安全性比较:一项随机交叉试验

Comparison of the Efficacy and Safety of Insulin Detemir and Insulin Glargine in Hospitalized Patients with Type 2 Diabetes: A Randomized Crossover Trial.

作者信息

Zhang Tong, Lin Mingrun, Li Wangen, Fan Xiuyun, Du Tao, Zhao Yunjuan, Zhang Xiaodan

机构信息

Department of Endocrinology and Metabolism, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.

Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

出版信息

Adv Ther. 2016 Feb;33(2):178-85. doi: 10.1007/s12325-016-0288-7. Epub 2016 Jan 25.

DOI:10.1007/s12325-016-0288-7
PMID:26809253
Abstract

INTRODUCTION

Previous studies comparing insulin detemir versus insulin glargine showed conflicting results, and included only outpatients. This study compared the two insulin analogs once daily in hospitalized patients with type 2 diabetes (T2D).

METHODS

A total of 55 patients aged 18-80 years with hyperglycemia admitted to the endocrinology wards were screened between June 2014 and February 2015. Forty-two enrolled patients were randomly assigned to receive either insulin detemir followed by insulin glargine once daily (n = 21), or vice versa (n = 21). The two insulin analogs were titrated 0.1 U/kg once daily based on fasting blood glucose (FBG). After achieving FBG <7.8 mmol/L (the first period), subjects were switched from one analog to the other (the second period) with no change in the dose. The second period lasted for 3 days. When hypoglycemia occurred in the second period, the observation was discontinued. Six-point blood glucose including FBG, 2 h after breakfast, lunch, dinner, bedtime, and at 3:00 am was tested every day. The glucose profiles of the final days in the two periods were compared.

RESULTS

At the end of the first period, days for achieving FBG target (4.0 ± 0.5 days vs. 3.3 ± 0.4 days, t = 1.079, P = 0.286) and total daily dose (30.1 ± 2.4 U vs. 30.1 ± 2.9 U, t = 0.002, P = 0.999) between insulin detemir and insulin glargine were similar. There was no significant difference in the 24-h glucose control between the two analogs. No hypoglycemia occurred with both analogs in the first period. However, in the second period, when insulin glargine was switched to insulin detemir, two, three and, one patients had hypoglycemia events on day 1, day 2 and day 3 of the second period, respectively. One patient had severe hypoglycemia on day 1.

CONCLUSION

When both basal insulin analogs were given once daily in T2D, insulin detemir achieved similar efficacy to insulin glargine. On the other hand, there may be differences in action of the compared basal insulins. Further studies with larger patient samples are necessary to support evidence and reveal possible mechanisms.

摘要

引言

既往比较地特胰岛素与甘精胰岛素的研究结果相互矛盾,且仅纳入了门诊患者。本研究对住院的2型糖尿病(T2D)患者每日一次使用这两种胰岛素类似物进行了比较。

方法

2014年6月至2015年2月期间,对内分泌科病房收治的55例年龄在18 - 80岁的高血糖患者进行了筛查。42例入选患者被随机分为两组,一组先每日一次接受地特胰岛素治疗,随后接受甘精胰岛素治疗(n = 21),另一组则相反(n = 21)。根据空腹血糖(FBG),两种胰岛素类似物均每日一次滴定至0.1 U/kg。在空腹血糖<7.8 mmol/L后(第一阶段),受试者从一种类似物转换为另一种类似物(第二阶段),剂量不变。第二阶段持续3天。当第二阶段发生低血糖时,停止观察。每天检测包括空腹血糖、早餐后2小时、午餐后、晚餐后、睡前及凌晨3点的六点血糖。比较两个阶段最后一天的血糖谱。

结果

在第一阶段结束时,地特胰岛素与甘精胰岛素在达到空腹血糖目标的天数(4.0±0.5天 vs. 3.3±0.4天,t = 1.079,P = 0.286)和每日总剂量(30.1±2.4 U vs. 30.1±2.9 U,t = 0.002,P = 0.999)方面相似。两种类似物在24小时血糖控制方面无显著差异。在第一阶段,两种类似物均未发生低血糖。然而,在第二阶段,当从甘精胰岛素转换为地特胰岛素时,分别有2例、3例和1例患者在第二阶段的第1天、第2天和第3天发生低血糖事件。1例患者在第1天发生严重低血糖。

结论

在T2D患者中每日一次给予两种基础胰岛素类似物时,地特胰岛素与甘精胰岛素疗效相似。另一方面,所比较的基础胰岛素在作用方面可能存在差异。需要更大样本量的患者进行进一步研究以支持证据并揭示可能的机制。

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