Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury - Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial
Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury - Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial
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DOI：
10.1001/jama.277.20.1597
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发表时间：
1997-05-28
影响因子：
120.7
通讯作者：
Young, W
中科院分区：
文献类型：
--
作者：
Bracken, MB;Shepard, MJ;Young, W
目的：比较甲基强的松龙治疗急性脊髓损伤24小时与甲基强的松龙治疗48小时或甲磺酸替利拉唑治疗48小时的疗效。设计-双盲随机临床试验。设置-北美16个急性脊髓损伤中心。患者。-国家急性脊髓损伤研究中心(NASCIS)在损伤后8小时内确诊的499名急性脊髓损伤患者。干预-所有患者在随机前均静脉推注甲基强的松龙(30 mg/kg)。24小时方案组(n=166)给予甲泼尼龙5.4 mg/kg每小时静脉滴注，连续24小时；48小时方案组(n=167)给予甲基强的松龙每小时5.4 mg/kg静脉滴注，连续48小时；替拉扎德组(n=166)每隔6小时静脉滴注2.5 mg/kg甲磺酸替利拉扎特，连续48小时。结果：与治疗24小时的患者相比，治疗48小时的患者在伤后6周(P=0.09)和6个月(P=0.07)时运动功能恢复明显改善。在伤后3~8小时开始治疗的患者中，48小时甲基强的松龙方案在6周(P=0.04)和6个月(P=0.01)时疗效显著。接受48小时方案并在3至8小时开始治疗的患者在6个月后更有可能改善1个完整的神经学分级(P=.03)，在6个月的FIM中表现出更多的改善(P=.08)，并出现更严重的脓毒症和严重肺炎，但其他并发症和死亡率(P=.97)与24小时甲基强的松龙组和替拉扎组相似。接受替拉扎德治疗48小时的患者运动恢复率与接受甲基强的松龙治疗24小时的患者相当。结论：急性脊髓损伤患者在伤后3小时内接受甲基强的松龙治疗的患者应维持24小时的治疗方案。当伤后3至8小时开始使用甲基强的松龙时，患者应维持48小时的类固醇治疗。
Objective.-To compare the efficacy of methylprednisolone administered for 24 hours with methyprednisolone administered for 48 hours or tirilazad mesylate administered for 48 hours in patients with acute spinal cord injury.Design.-Double-blind, randomized clinical trial.Setting.-Sixteen acute spinal cord injury centers in North America.Patients.-A total of 499 patients with acute spinal cord injury diagnosed in National Acute Spinal Cord Injury Study (NASCIS) centers within 8 hours of injury.Intervention.-All patients received an intravenous bolus of methylprednisolone (30 mg/kg) before randomization. Patients in the 24-hour regimen group (n=166) received a methylprednisolone infusion of 5.4 mg/kg per hour for 24 hours, those in the 48-hour regimen group (n=167) received a methylprednisolone infusion of 5.4 mg/kg per hour for 48 hours, and those in the tirilazad group (n=166) received a 2.5 mg/kg bolus infusion of tirilazad mesylate every 6 hours for 48 hours.Main Outcome Measures.-Motor function change between initial presentation and at 6 weeks and 6 months after injury, and change in Functional independence Measure (FIM) assessed at 6 weeks and 6 months.Results.-Compared with patients treated with methylprednisolone for 24 hours, those treated with methylprednisolone for 48 hours showed improved motor recovery at 6 weeks (P=.09) and 6 months (P=.07) after injury. The effect of the 48-hour methylprednisolone regimen was significant at 6 weeks (P=.04) and 6 months (P=.01) among patients whose therapy was initiated 3 to 8 hours after injury. Patients who received the 48-hour regimen and who started treatment at 3 to 8 hours were more likely to improve 1 full neurologic grade (P=.03) at 6 months, to show more improvement in 6-month FIM (P=.08), and to have more severe sepsis and severe pneumonia than patients in the 24-hour methylprednisolone group and the tirilazad group, but other complications and mortality (P=.97) were similar, Patients treated with tirilazad for 48 hours showed motor recovery rates equivalent to patients who received methylprednisolone for 24 hours.Conclusions.-Patients with acute spinal cord injury who receive methylprednisolone within 3 hours of injury should be maintained on the treatment regimen for 24 hours. When methylprednisolone is initiated 3 to 8 hours after injury, patients should be maintained on steroid therapy for 48 hours.