Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up - Results of the third National Acute Spinal Cord Injury randomized controlled trial

Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up - Results of the third National Acute Spinal Cord Injury randomized controlled trial
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DOI:
10.3171/jns.1998.89.5.0699
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发表时间:
1998-11-01
影响因子:
4.1
通讯作者:
Young, W
Young, W
中科院分区:
医学1区
文献类型:
--
作者:
Bracken, MB;Shepard, MJ;Young, W

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物体。采用随机双盲临床试验,比较接受标准24小时甲基强的松龙方案(24MP)、相同MP方案48小时(48 MP)或48小时甲磺酸替利拉唑(48TM)治疗的急性脊髓损伤患者的神经和功能恢复情况以及1年后的发病率和死亡率。在受伤后3小时内开始治疗的患者在所有三个治疗组中都显示出同等的神经和功能恢复。延迟治疗超过3小时的患者,24MP组的运动功能恢复较差,而48MP组的患者I年运动恢复较好(恢复评分分别为13.7和19,p=0.053)。在48MP组中,患者改善三个或更多神经学分级的比例也更高(p=0.073)。总体而言,接受48TM治疗的患者与接受24MP治疗的患者恢复情况相同。在自我护理和括约肌控制方面也有相应的恢复,但在统计学上没有显着意义。所有患者1年内的死亡率和发病率均相似。对于在受伤后3小时内开始MP治疗的患者,24小时维持治疗是合适的。受伤后3至8小时开始治疗的患者应维持该方案48小时,除非有复杂的医疗因素。
Object. A randomized double-blind clinical trial was conducted to compare neurological and functional recovery and morbidity and mortality rates 1 year after acute spinal cord injury in patients who had received a standard 24-hour methylprednisolone regimen (24MP) with those in whom an identical MP regimen had been delivered for 48 hours (48MP) or those who had received a 48-hour tirilazad mesylate (48TM) regimen.Methods. Patients for whom treatment was initiated within 3 hours of injury showed equal neurological and functional recovery in all three treatment groups. Patients for whom treatment was delayed more than 3 hours experienced diminished motor function recovery in the 24MP group, but those in the 48MP group showed greater I-year motor recovery (recovery scores of 13.7 and 19, respectively, p = 0.053). A greater percentage of patients improving three or more neurological grades was also observed in the 48MP group (p = 0.073). In general, patients treated with 48TM recovered equally when compared with those who received 24MP treatments. A corresponding recovery in self care and sphincter control was seen but was not statistically significant. Mortality and morbidity rates at 1 year were similar in all groups.Conclusions. For patients in whom MP therapy is initiated within 3 hours of injury, 24-hour maintenance is appropriate. Patients starting therapy 3 to 8 hours after injury should be maintained on the regimen for 48 hours unless there are complicating medical factors.