Shepard M J, Bracken M B
Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT 06520-8034, USA.
Spinal Cord. 1999 Dec;37(12):833-7. doi: 10.1038/sj.sc.3100927.
Data are from a multicenter, randomized, double blind clinical trial of acute spinal cord injury.
To evaluate the prognostic value of magnetic resonance imaging (MRI) for randomized patients in the National Acute Spinal Cord Injury Study 3 (NASCIS).
Sixteen spinal cord injury centers throughout the United States and Canada.
Of 499 patients randomized in NASCIS 3 between December 1991 and September 1995, MRI was electively done on 191 patients within 72 h of injury. Indications of hemorrhage, edema, and contusion were recorded by standard protocol. Neurological impairment as determined by motor function, response to pin prick and light touch was assessed at admission to the participating center and 6 weeks after injury. Change in neurological function was obtained by subtracting the score of each neurological parameter at admission from that measured at 6 weeks. Spinal cord surgery performed within the 3 days after injury was noted. Data were analyzed by: chi square, analysis of variance, multiple logistic regression and linear regression models.
Patients with hemorrhage were much more likely to have a complete injury (OR=2.88, 95 Cl 1.32, 6.23); however this association was much reduced when the initial neurological examination was taken into account (AOR=1.43, 95% Cl 0.55, 3.73) and was no longer a significant predictor of injury. MRI evidence of cord edema was the strongest predictor of reduced improvement in motor function (-3.34 points, P=0.06) and light touch sensation (-3.41 points, P=0.05) at 6 weeks.
Cord hemorrhage, contusion, and edema on MRI were not associated with diagnosis of a complete cord injury after neurological assessment from the initial clinical examination was taken into account. Prediction of a worse 6 week neurological status was weakly associated with the presence of edema diagnosed by MRI. As MRI technology improves, these diagnostic and predictive capabilities need to be re-assessed.
NASCIS 3 was funded by the National Institute of Neurological Disorders and Stroke at the National Institutes of Health, Washington, DC, USA. Pharmacia and Upjohn provided study drugs and placebos; they also monitored data quality, and funded additional tests, in accordance with Food and Drug Administration regulatory requirements. Dr Bracken has served as an occasional paid consultant to Pharmacia and Upjohn.
数据来自一项关于急性脊髓损伤的多中心、随机、双盲临床试验。
评估磁共振成像(MRI)对国家急性脊髓损伤研究3(NASCIS)中随机分组患者的预后价值。
美国和加拿大的16个脊髓损伤中心。
在1991年12月至1995年9月期间参与NASCIS 3随机分组的499例患者中,191例患者在受伤后72小时内接受了选择性MRI检查。按照标准方案记录出血、水肿和挫伤的迹象。在参与研究的中心入院时和受伤后6周,评估由运动功能、对针刺和轻触觉的反应所确定的神经功能损害情况。通过用受伤6周时测量的每个神经学参数得分减去入院时的得分,得出神经功能的变化。记录受伤后3天内进行的脊髓手术情况。数据通过卡方检验、方差分析、多元逻辑回归和线性回归模型进行分析。
有出血的患者更有可能出现完全性损伤(比值比=2.88,95%置信区间1.32,6.23);然而,当考虑初始神经学检查时,这种关联大大降低(校正比值比=1.43,95%置信区间0.55,3.73),且不再是损伤的显著预测因素。脊髓水肿的MRI证据是6周时运动功能改善降低(-3.34分,P=0.06)和轻触觉感觉改善降低(-3.41分,P=0.05)的最强预测因素。
在考虑了初始临床检查的神经学评估后,MRI上的脊髓出血、挫伤和水肿与完全性脊髓损伤的诊断无关。6周时神经状态较差的预测与MRI诊断的水肿存在弱相关。随着MRI技术的改进,这些诊断和预测能力需要重新评估。
NASCIS 3由美国国立卫生研究院华盛顿特区国家神经疾病和中风研究所资助。辉瑞和优普强提供研究药物和安慰剂;他们还按照美国食品药品监督管理局的监管要求监测数据质量,并资助额外的检测。布雷肯博士曾偶尔担任辉瑞和优普强的付费顾问。