Alibai Ehsan Ali, Baghban Fahim, Farrokhi Majid Reza, Mohebali Navideh, Ashraf Mohammad Hossein
Department of Neurosurgery, Shiraz University of Medical Science, Shiraz, Iran.
Bull Emerg Trauma. 2015 Jul;3(3):79-85.
To determine the effects of recombinant human erythropoietin (rhEPO) on functional outcome and disability of patients with traumatic cervical spinal cord injury (SCI).
This was a randomized, double blind, placebo controlled clinical trial being performed in Nemazee and Shahid Rajaei hospitals of Shiraz during a 3-year period from 2011 to 2014. A total number of 20 patients with acute traumatic cervical SCI less than 8 hours after injury were included. We excluded those with anatomic cord dissection, penetrating cord injury and significant concomitant injury. Patients were randomly assigned to receive rhEPO in 500IU/mL dosage immediately and 24-hour later (n=11) or placebo (n=9). All the patient received standard regimen of methylprednisolone. Neurological function was assessed on admission, 1, 6 and 12 months after the injury according to the American Spinal Cord Injury Association (ASIA).
Overall we include a total number of 20 patients. The mean age of the patients was found to be 40.1±9.5 (ranging from 19 to 59) years. There were 18 (90.0%) men and 2 (10.0%) women among the patients. There was no significant difference between two study groups regarding the baseline characteristics. The baseline ASIA score was comparable between two study groups. The motor and sensory ASIA scores were comparable between two study groups after 1, 6 and 12 months follow-ups. We also found that there was no significant difference between two study groups regarding the motor and sensory outcome in complete cord injury and incomplete cord injury subgroups.
Administration of rhEPO does not improve the functional outcome of patients with traumatic cervical SCI.
确定重组人促红细胞生成素(rhEPO)对创伤性颈脊髓损伤(SCI)患者功能结局和残疾情况的影响。
这是一项随机、双盲、安慰剂对照临床试验,于2011年至2014年在设拉子的内马齐医院和沙希德拉贾伊医院进行,为期3年。纳入了总共20例受伤后8小时内的急性创伤性颈脊髓损伤患者。我们排除了那些有解剖学脊髓离断、穿透性脊髓损伤和严重合并伤的患者。患者被随机分配接受500IU/mL剂量的rhEPO,立即给药并在24小时后再次给药(n = 11)或接受安慰剂(n = 9)。所有患者均接受甲基泼尼松龙标准治疗方案。根据美国脊髓损伤协会(ASIA)标准,在入院时、受伤后1、6和12个月评估神经功能。
总体而言,我们共纳入了20例患者。患者的平均年龄为40.1±9.5岁(范围为19至59岁)。患者中有18名(90.0%)男性和2名(10.0%)女性。两个研究组在基线特征方面没有显著差异。两个研究组的基线ASIA评分相当。在1、6和12个月的随访后,两个研究组的运动和感觉ASIA评分相当。我们还发现,在完全性脊髓损伤和不完全性脊髓损伤亚组中,两个研究组在运动和感觉结局方面没有显著差异。
给予rhEPO并不能改善创伤性颈脊髓损伤患者的功能结局。