Patrick Peter D, Blackman James A, Mabry Jennifer L, Buck Marcia L, Gurka Matthew J, Conaway Mark R
Department of Pediatrics, Kluge Children's Rehabilitation Center, University of Virginia Children's Hospital, Charlottesville, VA 22901, USA.
J Child Neurol. 2006 Oct;21(10):879-85. doi: 10.1177/08830738060210100901.
The objective of this study was to determine whether a dopamine agonist could improve mental status among children in a low-response state following traumatic brain injury. In an 8-week, prospective, double-blind, randomized trial, 10 children and adolescents ages 8 to 21 years (X = 16.7 years) with traumatic brain injury sustained at least 1 month previously and remaining in a low-response state (Rancho Los Amigos Scale level pound 3) received pramipexole or amantadine. Medication dosage was increased over 4 weeks, weaned over 2 weeks, and then discontinued. At baseline and weekly during the study, subjects were evaluated with the Coma Near Coma Scale, Western NeuroSensory Stimulation Profile, and Disability Rating Scale. Scores improved significantly from baseline to the medication phase on the Coma Near Coma Scale, Western NeuroSensory Stimulation Profile, and Disability Rating Scale (P < .005). The weekly rate of change was significantly better for all three measures on medication than off medication (P < .05). Rancho Los Amigos Scale levels improved significantly on medication as well (P < .05). There was no difference in efficacy between amantadine and pramipexole. No unexpected or significant side effects were observed with either drug. This clinical trial supports the benefit of two dopamine agonists in the restoration of functional arousal, awareness, and communication. These drugs can be helpful in accelerating eligibility for acute rehabilitation among children and adolescents who have sustained significant brain injuries.
本研究的目的是确定多巴胺激动剂是否能改善创伤性脑损伤后处于低反应状态儿童的精神状态。在一项为期8周的前瞻性、双盲、随机试验中，10名年龄在8至21岁（平均年龄16.7岁）、至少在1个月前遭受创伤性脑损伤且仍处于低反应状态（兰乔斯阿米戈斯量表3级及以下）的儿童和青少年接受了普拉克索或金刚烷胺治疗。药物剂量在4周内增加，在2周内逐渐减少，然后停药。在基线期以及研究期间每周，使用昏迷近昏迷量表、西部神经感觉刺激量表和残疾评定量表对受试者进行评估。在昏迷近昏迷量表、西部神经感觉刺激量表和残疾评定量表上，从基线期到用药阶段，分数均有显著改善（P < .005）。对于所有这三项测量指标，用药时每周的变化率显著优于停药时（P < .05）。用药时兰乔斯阿米戈斯量表水平也有显著改善（P < .05）。金刚烷胺和普拉克索在疗效上没有差异。两种药物均未观察到意外或显著的副作用。这项临床试验支持了两种多巴胺激动剂在恢复功能性觉醒、意识和交流方面的益处。这些药物有助于加快重度脑损伤儿童和青少年进入急性康复阶段的进程。
