A RANDOMIZED, CONTROLLED TRIAL OF METHYLPREDNISOLONE OR NALOXONE IN THE TREATMENT OF ACUTE SPINAL-CORD INJURY - RESULTS OF THE 2ND NATIONAL ACUTE SPINAL-CORD INJURY STUDY
A RANDOMIZED, CONTROLLED TRIAL OF METHYLPREDNISOLONE OR NALOXONE IN THE TREATMENT OF ACUTE SPINAL-CORD INJURY - RESULTS OF THE 2ND NATIONAL ACUTE SPINAL-CORD INJURY STUDY
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DOI：
10.1056/nejm199005173222001
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发表时间：
1990-05-17
影响因子：
158.5
通讯作者：
WINN, HR
中科院分区：
文献类型：
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作者：
BRACKEN, MB;SHEPARD, MJ;WINN, HR
动物研究表明，甲基强的松龙和纳洛酮都是潜在的有益的急性脊髓损伤，但是否有任何治疗是临床有效的仍然不确定。我们在一项多中心、随机、双盲、安慰剂对照试验中评估了甲基强的松龙和纳洛酮在急性脊髓损伤患者中的疗效和安全性，其中95%的患者在损伤后14小时内接受了治疗。162例患者按30 mg/kg体重静脉推注甲基强的松龙，然后以5.4mg/kg/h持续静脉滴注23小时。154例患者接受纳洛酮5.4 mg/kg的推注，随后171例患者接受4.0 mg/kg的推注和输注。在入院时、伤后6周和6个月通过系统的神经系统检查评估运动和感觉功能。6个月后，在受伤后8小时内接受甲基强的松龙治疗的患者与接受安慰剂治疗的患者相比，运动功能有显着改善（神经功能变化评分分别为16.0和11.2; P = 0.03）和针刺感觉（变化评分为11.4和6.6; P = 0.02）和触摸（变化评分为8.9和4.3; P = 0.03）。甲基强的松龙的益处见于最初被评估为神经学完全损伤的患者，以及那些被认为具有不完全损伤的患者。在受伤后8小时以上接受纳洛酮或甲基强的松龙治疗的患者，其神经功能结局与接受安慰剂治疗的患者没有差异。所有三组的死亡率和主要发病率相似。我们的结论是，在急性脊髓损伤的患者中，在本研究中使用的剂量甲基强的松龙治疗改善神经功能恢复时，在第一个8小时内给予药物。我们还得出结论，在本研究中使用剂量的纳洛酮治疗并不能改善急性脊髓损伤后的神经功能恢复。
Studies in animals indicate that methylprednisolone and naxloxone are both potentially beneficial in acute spinal-cord injury, but whether any treatment is clinically effective remains uncertain. We evaluated the efficacy and safety of methylprednisolone and naloxone in a multicenter randomized, double-blind placebo-controlled trial in patients with acute spinal cord injury, 95 percent of whom were treated within 14 hours of injury. Methylprednisolone was given to 162 patients as a bolus of 30 mg per kilogram of body weight, followed by infusion at 5.4mg kilogram per hour for 23 hours. Naloxone was given to 154 patients as a bolus of 5.4 mg per kilogram, followed by infusion at 4.0 mg per 171 patients by bolus and infusion. Motor and sensory functions were assessed by systematic neurologic examination on admission and six weeks and six months after injury. After six months the patients who were treated with methylprednisolone within eight hours of their injury had significant improvement as compared with those given placebo in motor function (neurologic change scores of 16.0 and 11.2, respectively; P = 0.03) and sensation to pinprick (change scores of 11.4 and 6.6; P = 0.02) and touch (change scores, 8.9 and 4.3; P = 0.03). Benefit from methylprednisolone was seen in patients whose injuries were initially evaluated as neurologically complete, as well as in those believed to have incomplete lesions. The patients treated with naloxone, or with methylprednisolone more than eight hours after their injury, did not differ in their neurologic outcomes from those given placebo. Mortality and major morbidity were similar in all three groups. We conclude that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours. We also conclude that treatment with naloxone in the dose used in this study does not improve neurologic recovery after acute spinal-cord injury.