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口服格列本脲对中重度创伤性脑损伤患者脑挫伤体积和功能结局的影响:一项随机双盲安慰剂对照临床试验

Effects of Oral Glibenclamide on Brain Contusion Volume and Functional Outcome of Patients with Moderate and Severe Traumatic Brain Injuries: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

作者信息

Khalili Hosseinali, Derakhshan Nima, Niakan Amin, Ghaffarpasand Fariborz, Salehi Mohammad, Eshraghian Hamed, Shakibafard Alireza, Zahabi Bita

机构信息

Trauma Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Neurosurgery, Shiraz University of Medical Sciences, Shiraz, Iran.

Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Neurosurgery, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

World Neurosurg. 2017 May;101:130-136. doi: 10.1016/j.wneu.2017.01.103. Epub 2017 Feb 7.

DOI:10.1016/j.wneu.2017.01.103
PMID:28185976
Abstract

OBJECTIVE

This study investigated effects of oral glibenclamide on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injuries.

METHODS

A randomized clinical trial including 66 patients with moderate (Glasgow Coma Scale score 9-12) to severe (Glasgow Coma Scale score 5-8) traumatic brain injury and brain contusions of <30 mL volume was conducted from May 2015 to August 2016 in a Level I trauma center in southern Iran. Patients who required surgical intervention were excluded. Patients were randomly assigned to receive 10 mg oral glibenclamide daily for 10 days (n = 29) or placebo in the same dosage (n = 23). Brain contusion volumetry was performed on days 0, 3, and 7 using spiral thin-cut brain computed tomography scan (1-mm thickness). Outcome measures including modified Rankin Scale, Glasgow Outcome Scale, and Disability Rating Scale were evaluated 3 months after injury.

RESULTS

There was no significant difference between the 2 study groups in baseline, day 3, and day 7 contusion volumes. Patients receiving glibenclamide had a significantly lower expansion ratio from first to second volumetry (P < 0.001). Similarly, the first to third expansion ratio was significantly lower in the glibenclamide group compared with placebo (P = 0.003). There was no significant difference between the 2 groups regarding functional outcome measured by Glasgow Outcome Scale, modified Rankin Scale, and Disability Rating Scale.

CONCLUSIONS

Oral glibenclamide is associated with decreased contusion expansion rate in patients with moderate and severe traumatic brain injuries sustaining cerebral contusions.

摘要

目的

本研究调查了口服格列本脲对中重度创伤性脑损伤患者脑挫伤体积和功能预后的影响。

方法

2015年5月至2016年8月,在伊朗南部的一家一级创伤中心进行了一项随机临床试验,纳入66例中重度(格拉斯哥昏迷量表评分为9 - 12分)创伤性脑损伤且脑挫伤体积<30 mL的患者。需要手术干预的患者被排除。患者被随机分配,每天口服10 mg格列本脲,共10天(n = 29),或服用相同剂量的安慰剂(n = 23)。在第0、3和7天使用螺旋薄层脑计算机断层扫描(厚度1 mm)进行脑挫伤体积测量。在受伤3个月后评估包括改良Rankin量表、格拉斯哥预后量表和残疾评定量表在内的预后指标。

结果

两个研究组在基线、第3天和第7天的挫伤体积无显著差异。接受格列本脲治疗的患者从第一次到第二次体积测量的扩张率显著更低(P < 0.001)。同样,与安慰剂组相比,格列本脲组从第一次到第三次的扩张率显著更低(P = 0.003)。在通过格拉斯哥预后量表、改良Rankin量表和残疾评定量表测量的功能预后方面,两组之间没有显著差异。

结论

口服格列本脲与中重度创伤性脑损伤并伴有脑挫伤患者的挫伤扩张率降低有关。

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