重组人促红细胞生成素联合甲泼尼龙琥珀酸钠治疗急性脊髓损伤的临床效果观察

Observation of clinical effects of recombinant human erythropoietin combined with methylprednisolone sodium succinate in the treatment of acute spinal cord injury

目的 评价重组人促红细胞生成素联合甲泼尼龙琥珀酸钠与单独应用甲泼尼龙琥珀酸钠治疗急性脊髓损伤（SCI）神经功能恢复情况.方法 入选受伤8 h内就诊的SCI患者21例,随机分成对照组10例,干预组11例.对照组应用甲泼尼龙琥珀酸钠＋安慰剂组治疗;干预组应用甲泼尼龙琥珀酸钠＋重组人促红细胞生成素治疗.两组患者最开始1 h内均接受30 mg/kg的甲泼尼龙琥珀酸钠治疗,如果受伤4 h内就诊,在随后的23 h内接受每小时5.4 mg/kg的甲泼尼龙琥珀酸钠治疗,如果受伤4~8 h内就诊,在随后的47 h内持续应用5.4 mg/kg的甲泼尼龙琥珀酸钠.干预组患者就诊时接受500 U/kg重组人促红细胞生成素治疗,随后24 h内再接受500 U/kg重组人促红细胞生成素治疗.而甲泼尼龙琥珀酸钠组采用安慰剂做对比.在入院时、24 h、72 h、1周、2个月、6个月分别评价神经功能恢复情况,并进行统计学分析.结果 美国脊髓损伤协会（ASIA）评分的变化：两组患者运动;痛觉和触觉随着时间的延长而增加,而且干预组较对照组增加幅度大,两组ASIA评分比较差异有统计学意义（P均〈0.05）.两组患者血常规的红细胞数量和血红蛋白含量比较没有明显差异（P均〉0.05）.结论 与安慰剂相比,SCI患者损伤8 h内应用甲泼尼龙琥珀酸钠联合重组人促红细胞生成素能有效地促进患者的神经功能恢复.

Objective To evaluate the effect of recombinant human erythropoietin （rhEPO） combined with methylprednisolone sodium succinate （MPSS）,compared to MPSS alone,in the treatment of neurological function of patients with acute spinal cord injury （SCI）.Methods Twenty-one patients presenting in hospital within less than 8 hours after acute SCI were randomly divided into two groups,the control group （10 cases） and the intervention group （11 cases）.The control group was treated by MPSS combined with placebo,while the intervention group received MPSS with rhEPO.Both groups received MPSS 30 mg/kg within the first hour,and if the patient was admitted within 4 hours,MPSS would be applied in the treatment with 5.4 mg/kg per hour in the subsequent 23 hours and till 47 hours if the patient was admitted within 4-8 hours after injury.The intervention group received 500 U/kg rhEPO on admission and another 500 U/kg in the next 24 hours,compared with the control group where placebo was used.The evaluation on neurologic function recovery was made on admission,24 h,72 h,one week,2 months and 6 months later,and statistical analysis was performed.Results The change in ASIA score： in the control group,the increase was seen from admission to 6 months after injury in terms of exercise,algesia and tactile sensation （（31.2±6.6） points vs.（57.8±9.8） points,（41.4±9.5） points vs.（64.3±10.6） points, （39.2±6.8） points vs,（61.5±11.3） points）,the increase also took place in the intervention group （（29.5±7.2） points vs.（77.4±10.3） points,（39.7±7.2） points vs.（82.3±12.1） points,（37.4±6.2） points vs.（78.6±12.4） points）.As time went on,the increase range in the intervention group became larger,compared with the control group.The difference between the two groups in ASLA score was statistically significant （P〈0.05）.There was no significant difference in red blood cell count and hemoglobin content of routine blood test between the two groups （P〉0.05）.Conclusion The application of MPSS combined with rhEPO within 8 hours after acute spinal injury may be more effective than MPSS with placebo in the neurologic dysfunction recovery.