Segal J L, Maltby B F, Langdorf M I, Jacobson R, Brunnemann S R, Jusko W J
Medical and Spinal Cord Injury Service, Department of Veterans Affairs Medical Center, Long Beach, California 90822, USA.
Pharmacotherapy. 1998 Jan-Feb;18(1):16-22.
To evaluate the pharmacokinetics of high-dose methylprednisolone in patients with acute spinal cord injury (ASCI).
Open-label study of consecutive patients with ASCI, and retrospective review of able-bodied controls.
Emergency Medicine Department of a large, urban, university-affiliated, tertiary care trauma center.
Eleven men with ASCI.
Methylprednisolone sodium succinate 30 mg/kg intravenous bolus, followed by 5.4 mg/kg/hour for 23 hours, administered according to the second National Acute Spinal Cord Injury Study (NASCIS 2) protocol.
The total systemic clearance of methylprednisolone was significantly less in acutely injured patients (mean +/- SD 30.04 +/- 12.03 L/hr) than in historically reported able-bodied controls (44.70 +/- 4.90 L/hr). An inverse correlation between the neurologic level of injury and systemic clearance was seen. No differences in volume of distribution were discernible between patients (126.90 L) and controls (135.45 L).
Patients with acute spinal cord injury administered methylprednisolone according to the NASCIS 2 protocol had an apparent decrease in total systemic clearance of the drug without a commensurate change in volume of distribution. Additional studies are warranted to confirm these findings and assess the potential impact of diminished clearance on the efficacy of the agent in ASCI.
评估大剂量甲泼尼龙在急性脊髓损伤（ASCI）患者中的药代动力学。
对连续的ASCI患者进行开放标签研究，并对健康对照者进行回顾性分析。
一所大型城市大学附属三级创伤中心的急诊科。
11名男性ASCI患者。
按照第二次全国急性脊髓损伤研究（NASCIS 2）方案，静脉推注甲泼尼龙琥珀酸钠30 mg/kg，随后以5.4 mg/kg/小时的速度给药23小时。
急性损伤患者中甲泼尼龙的全身总清除率（平均±标准差30.04±12.03 L/小时）显著低于历史报道的健康对照者（44.70±4.90 L/小时）。损伤的神经学水平与全身清除率之间呈负相关。患者（126.90 L）和对照者（135.45 L）之间的分布容积无差异。
按照NASCIS 2方案接受甲泼尼龙治疗的急性脊髓损伤患者，该药物的全身总清除率明显降低，而分布容积没有相应变化。需要进一步研究以证实这些发现，并评估清除率降低对该药物在ASCI中疗效的潜在影响。
