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The related main theme: A. Stroke and Cerebral vascular disorders

甘精胰島素在急性腦中風病患併有高血糖且需加護照護的效力及安全性: 隨機臨床試驗研究

Efficacy and Safety of Insulin Glargine in Patients With Acute Stroke and Hyperglycemia Receiving Intensive Care: A Randomized Controlled Study

Authers:

湯頌君, PhD, MD 1 , 施翔蓉, PhD, MD 2 , 林欣儀,  3 , 陳志昊, PhD, MD 1 , 葉馨喬, MD 1 , 蔡力凱, PhD, MD 1 , 楊偉勛, PhD, MD 2 , 鄭建興, PhD, MD 1 , 
Tang  Sung-Chun, PhD, MD 1 , Shih  Shyang-Rong , PhD, MD 2 , Lin  Shin-Yi ,  3 , Chen  Chih-Hao , PhD, MD 1 , Yeh  Shin-Joe , MD 1 , Tsai  Li-Kai , PhD, MD 1 , Yang  Wei-Shiung, PhD, MD 2 , Jiann-Shing  Jeng, PhD, MD 1 , 
1 臺大醫院神經部
2 臺大醫院內科部
3 臺大醫院藥劑部
1 Department of Neurology, National Taiwan University Hospital
2 Department of Internal Medicine, National Taiwan University Hospital
3 Department of Pharmacy, National Taiwan University Hospital
Corresponding Author:

鄭建興
Jeng  Jiann-Shing , PhD, MD
臺大醫院神經部
Department of Neurology, National Taiwan University Hospital

keywords: Stroke, hyperglycemia, insulin Glargin, NPH, intensive care
Abstract for original article

OBJECTIVES /BACKGROUND:
This pilot study compared the basal–bolus regimens of long-acting insulin glargine (IG) and neutral protamine Hagedorn (NPH) insulin in efficacy and safety in acute stroke patients with hyperglycemia receiving intensive care

MATERIAL and METHOD:
This was a randomized, open-label, clinical trial. Stroke patients who were admitted to the intensive care unit within 72 h of onset and met the inclusion criteria were enrolled. They received either IG or NPH with added short-acting prandial regular insulin over a 72-h period. The primary endpoints were the percentage of glucose within the range of 80 to 180 mg/dL, assessed through continuous glucose monitoring (CGM).

RESULT:
A total of 50 patients were included, 26 and 24 were randomly assigned to the IG and NPH, respectively. The participant baseline characteristics were comparable between groups, except the IG had a significantly higher glucose level pre-randomization than the NPH (290.69 ± 82.31 versus 246.04 ± 41.76 mg/dL, P = .021). CGM data showed that the percentage of time with glucose levels between 80 and 180 mg/dL was 45.88 ± 27.04% in the IG and 53.56 ± 22.89% in the NPH (P = .341) and the percentage of glucose reduction was 31.47 ± 17.52% in the IG and 27.28 ± 14.56% in the NPH (P = .374). The percentage of time with hypoglycemia (< 60 mg/dl) was 0.14 ± 0.49% in the IG and 0.47 ± 1.74% in the NPH (P = .361). Parameters representative of glucose variabilities, and poststroke outcomes were not significantly different between the groups.

DISCUSSION:
Our study results suggest that early initiation of an IG-based basal–bolus regimen is safe and equally effective as an NPH-based basal-bolus regimen for patients with acute stroke and hyperglycemia requiring intensive care.


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