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模拟胰岛素与人类胰岛素治疗急性卒中住院患者高血糖的疗效和安全性比较:一项随机、开放标签、单中心试验

Efficacy and Safety of Analog Insulin in Comparison With Human Insulin for Hyperglycemia in Hospitalized Patients With Acute Stroke: A Randomized, Open-Label, Single-Center Trial.

作者信息

Hasan Mashfiqul, Atiqur-Rahman Mohammad, Chowdhury Sharmin, Esteak Tareq, Naznin Jobaida, Shahi Mohammad Selim

机构信息

Department of Endocrinology, National Institute of Neurosciences and Hospital, Sher-E-Bangla Nagar, Agargaon, Dhaka, Bangladesh.

Department of Endocrinology, National Institute of Neurosciences and Hospital, Sher-E-Bangla Nagar, Agargaon, Dhaka, Bangladesh.

出版信息

Endocr Pract. 2023 Jan;29(1):18-23. doi: 10.1016/j.eprac.2022.10.180. Epub 2022 Nov 1.

Abstract

OBJECTIVE

To assess the efficacy and safety of analog insulins in comparison with human insulins for hyperglycemia in hospitalized patients with acute stroke.

METHODS

In this single-center, open-label, randomized trial, 102 patients (age 59.4 ± 11.7 years, 54 women) admitted with acute stroke (52 ischemic, 50 hemorrhagic) and hyperglycemia were assigned to analog insulin (n = 52) or human insulin (n = 50) group during February to June 2021. Insulin was initiated and titrated according to the predefined standard protocol. The capillary blood glucose (BG) level was monitored by standardized glucometers. The primary outcomes were mean daily BG and the number of hypoglycemic events.

RESULTS

Between the 2 treatment groups, there was no significant difference in the mean daily BG (P >.05 for all days) or in the frequency of hypoglycemic episodes (P =.727). Four participants experienced severe hypoglycemia; all were receiving human insulin (P =.054). In the analog insulin group, there was a tendency toward lower daily total requirement for insulin (P =.053). The difference in bolus insulin dose was significantly lower in the analog insulin group (P =.029), but the difference in basal insulin dose was similar (P =.167). Between the 2 groups, there were no significant differences in the hospital mortality rate, modified Rankin Scale score on outcome, or length of hospital stay (P =.729,.658, and.918, respectively).

CONCLUSION

Hospitalized patients acute stroke and hyperglycemia exhibited similar mean BG but a trend of lower incidence of severe hypoglycemia when treated with analog insulins in comparison with human insulin.

摘要

目的

评估与人类胰岛素相比,类似物胰岛素治疗急性卒中住院患者高血糖的疗效和安全性。

方法

在这项单中心、开放标签、随机试验中,2021年2月至6月期间,102例因急性卒中(52例缺血性,50例出血性)和高血糖入院的患者(年龄59.4±11.7岁,54例女性)被分配到类似物胰岛素组(n = 52)或人类胰岛素组(n = 50)。根据预定义的标准方案启动并调整胰岛素剂量。使用标准化血糖仪监测毛细血管血糖(BG)水平。主要结局指标为每日平均BG和低血糖事件数量。

结果

两个治疗组之间,每日平均BG(所有天数P>0.05)或低血糖发作频率(P = 0.727)无显著差异。4名参与者发生严重低血糖;均接受人类胰岛素治疗(P = 0.054)。在类似物胰岛素组中,胰岛素每日总需求量有降低趋势(P = 0.053)。类似物胰岛素组的推注胰岛素剂量差异显著更低(P = 0.029),但基础胰岛素剂量差异相似(P = 0.167)。两组之间,医院死亡率、改良Rankin量表结局评分或住院时间无显著差异(分别为P = 0.729、P = 0.658和P = 0.918)。

结论

与人类胰岛素相比,急性卒中合并高血糖的住院患者使用类似物胰岛素治疗时,平均BG相似,但严重低血糖发生率有降低趋势。

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