Moss Rehabilitation Research Institute and MossRehab, Elkins Park, PA.
Arch Phys Med Rehabil. 2013 Oct;94(10):1877-83. doi: 10.1016/j.apmr.2012.12.027. Epub 2013 Jun 2.
To assess the incidence of medical complications in patients with recent traumatic disorders of consciousness (DOCs).
Data on adverse events in a placebo controlled trial of amantadine hydrochloride revealed no group difference, which allowed these events to be reanalyzed descriptively as medical complications experienced by the 2 groups collectively.
Eleven clinical facilities in the United States, Denmark, and Germany with specialty rehabilitation programs for patients with DOCs.
Patients (N=184) with nonpenetrating traumatic brain injury enrolled from acute inpatient rehabilitation programs between 4 and 16 weeks postinjury.
Participants were randomized to receive 200 to 400mg of amantadine hydrochloride or placebo daily for 4 weeks, and followed for an additional 2 weeks. Adverse events were recorded and categorized with respect to their nature, timing, and severity.
Number, type, and severity of medical complications occurring during the 6-week study interval.
A total of 468 medical complications were documented among the patients (.40 events per week per patient). More than 80% of patients experienced at least 1 medical complication, and 41 of these were defined as serious adverse events. New medical complications declined over time in rehabilitation and were not dependent on time since injury. Hypertonia, agitation/aggression, urinary tract infection, and sleep disturbance were the most commonly reported problems. Hydrocephalus, pneumonia, gastrointestinal problems, and paroxysmal sympathetic hyperactivity were the most likely to be severe.
Patients with DOCs have a high rate of medical complications early after injury. Many of these complications require brain injury expertise for optimal management. Active medical management appears to contribute to the reduction in new complications. An optimal system of care for DOC patients must provide expert medical management in the early weeks after injury.
评估近期创伤性意识障碍（DOC）患者的医疗并发症发生率。
对盐酸金刚烷胺安慰剂对照试验中的不良事件数据进行分析，结果未显示出组间差异，因此可以将这些事件作为两组共同经历的医疗并发症进行描述性再分析。
美国、丹麦和德国的 11 个临床机构，设有专门的 DOC 患者康复计划。
4 至 16 周外伤后从急性住院康复计划中招募的非穿透性创伤性脑损伤患者（N=184）。
参与者被随机分配每天接受 200 至 400mg 盐酸金刚烷胺或安慰剂治疗 4 周，并在随后的 2 周内进行随访。记录不良事件，并根据其性质、时间和严重程度进行分类。
6 周研究期间发生的医疗并发症的数量、类型和严重程度。
共记录了 184 名患者的 468 例医疗并发症（每位患者每周每例发生 0.40 例）。超过 80%的患者至少经历了 1 次医疗并发症，其中 41 例被定义为严重不良事件。新的医疗并发症在康复过程中随时间逐渐减少，与受伤时间无关。张力亢进、激越/攻击、尿路感染和睡眠障碍是最常见的问题。脑积水、肺炎、胃肠道问题和阵发性交感神经过度活跃是最有可能严重的。
DOC 患者在受伤后早期有很高的医疗并发症发生率。这些并发症中的许多需要脑损伤专业知识进行最佳管理。积极的医疗管理似乎有助于减少新的并发症。DOC 患者的最佳护理系统必须在受伤后的早期提供专家级别的医疗管理。
