Alibai Ehsanali, Zand Farid, Rahimi Aziz, Rezaianzadeh Abbas
Department of Neurosurgery, Faculty of Medicine, Shiraz University of Medical Sciences, Fars, Iran
Shiraz Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Fars, Iran
Acta Med Iran. 2014;52(4):275-9.
Recent studies in animal models indicate that recombinant human erythropoietin (rhEPO) is very effective in enhancing neurological recovery after spinal cord injury (SCI). We aimed to evaluate the effect of rhEPO plus methylprednisolone sodium succinate (MPSS) compared to MPSS alone to improve neurological function of patients after SCI in a randomized clinical trial. During a 15-month period 30 patients presenting to emergency departments of two university affiliated hospitals within less than 6 hours after acute SCI were randomized to two groups. Both groups received MPSS 30 mg/kg initially and 5.4 mg/kg every hour till 23 hours if admitted within 3 hours and till 47 hours if recruited within 3-6 hours after injury. Group EPO also received 500 unit/kg rhEPO on admission and another 500 unit/kg 24 hours later instead of placebo in group MPSS. Neurologic evaluation was performed on admission, 24, 48, 72 hours and one and 6 months later. Range of patients' age was 18-65 years. There was no significant difference between patients receiving two types of treatment in neurological exam on admission (P=0.125), 24 hours after admission (P=0.108) and 48 hours after admission (P=0.085). However, one week (P=0.046), one month (P=0.021) and six months (P=0.018) after admission these differences were significant. MPSS plus rhEPO started within 6 hours after acute spinal injury may be more effective than MPSS plus placebo in improvement of neurologic dysfunction. More studies with larger sample sizes are warranted.
近期动物模型研究表明，重组人促红细胞生成素（rhEPO）在促进脊髓损伤（SCI）后神经功能恢复方面非常有效。我们旨在通过一项随机临床试验，评估rhEPO联合琥珀酸钠甲泼尼龙（MPSS）与单独使用MPSS相比，对SCI患者神经功能改善的效果。在15个月期间，30例急性SCI后6小时内到两家大学附属医院急诊科就诊的患者被随机分为两组。两组患者均在伤后3小时内入院时初始给予MPSS 30 mg/kg，之后每小时给予5.4 mg/kg，持续至23小时；若在伤后3 - 6小时内入院，则持续至47小时。EPO组在入院时还接受500单位/千克的rhEPO，24小时后再给予500单位/千克，而MPSS组给予安慰剂。在入院时、24、48、72小时以及1个月和6个月后进行神经功能评估。患者年龄范围为18 - 65岁。接受两种治疗的患者在入院时（P = 0.125）、入院后24小时（P = 0.108）和入院后48小时（P = 0.085）的神经检查中无显著差异。然而，入院后1周（P = 0.046）、1个月（P = 0.021）和6个月（P = 0.018）时这些差异具有统计学意义。急性脊髓损伤后6小时内开始使用MPSS加rhEPO可能比MPSS加安慰剂在改善神经功能障碍方面更有效。有必要进行更多更大样本量的研究。
