Schneider W N, Drew-Cates J, Wong T M, Dombovy M L
Department of Physical Medicine and Rehabilitation, St. Mary's Hospital, Unity Health System, Rochester 14611, USA.
Brain Inj. 1999 Nov;13(11):863-72. doi: 10.1080/026990599121061.
The objective of the current study was to determine the efficacy of amantadine in improving cognitive and behavioural performance in a traumatic brain injury (TBI) rehabilitation sample. The design was a prospective, randomized, double-blind, placebo-controlled, crossover design. Subjects were 10 adult traumatic brain injury patients in an acute brain injury rehabilitation unit. Subjects received a 2-week trail of amantadine or placebo, followed by a 2-week washout, then a 2-week trail of the alternative (placebo or amantadine). Neuropsychological outcome measures included orientation, attention, executive function, memory, orientation, behaviour, and a composite variable. Results of repeated measures ANOVA and regression analysis of slope/change showed a main effect of time, but no significant difference for amantadine versus placebo. In conclusion, although patients generally improved, this initial exploratory study found no differences in rate of cognitive improvement between subjects given amantadine versus those given placebo. However, the small sample size, heterogeneous population, acute time course, and large number of dependent variables limit power and generalizability. Implications are discussed for further research to better answer questions regarding efficacy of amantadine post-TBI.
本研究的目的是确定金刚烷胺在改善创伤性脑损伤（TBI）康复样本中的认知和行为表现方面的疗效。研究设计为前瞻性、随机、双盲、安慰剂对照、交叉设计。研究对象为急性脑损伤康复单元中的10名成年创伤性脑损伤患者。受试者接受为期2周的金刚烷胺或安慰剂试验，随后是2周的洗脱期，然后是为期2周的另一种药物（安慰剂或金刚烷胺）试验。神经心理学结果测量包括定向、注意力、执行功能、记忆、定向、行为以及一个综合变量。重复测量方差分析和斜率/变化的回归分析结果显示存在时间主效应，但金刚烷胺与安慰剂之间无显著差异。总之，尽管患者总体上有所改善，但这项初步探索性研究发现，服用金刚烷胺的受试者与服用安慰剂的受试者在认知改善率方面没有差异。然而，样本量小、人群异质性、急性病程以及大量的因变量限制了检验效能和普遍性。文中讨论了对进一步研究的启示，以便更好地回答有关TBI后金刚烷胺疗效的问题。
