Lee Hoon, Kim Sung-Wan, Kim Jae-Min, Shin Il-Seon, Yang Su-Jin, Yoon Jin-Sang
Department of Psychiatry and Research Institute of Medical Science, Chonnam National University Medical School, Kwangju, Republic of Korea.
Hum Psychopharmacol. 2005 Mar;20(2):97-104. doi: 10.1002/hup.668.
This study aimed to investigate the effects of methylphenidate and sertraline compared with placebo on various neuropsychiatric sequelae associated with traumatic brain injury (TBI).
This was a 4 week, double-blind, parallel-group trial. Thirty patients with mild to moderate degrees of TBI were randomly allocated to one of three treatment groups (n = 10 in each group) with matching age, gender and education, i.e. methylphenidate (starting at 5 mg/day and increasing to 20 mg/day in a week), sertraline (starting at 25 mg/day and increasing to 100 mg/day in a week) or placebo. At the baseline and at the 4 week endpoint, the following assessments were administered: subjective (Beck Depression Inventory) and objective (Hamilton Depression Rating Scale) measures of depression; Rivermead Postconcussion Symptoms Questionnaire for postconcussional symptoms; SmithKline Beecham Quality of Life Scale for quality of life; seven performance tests (Critical Flicker Fusion, Choice Reaction Time, Continuous Tracking, Mental Arithmetic, Short-Term memory, Digit Symbol Substitution and Mini-Mental State Examination); subjective measures of sleep (Leeds Sleep Evaluation Questionnaire) and daytime sleepiness (Epworth Sleepiness Scale). All adverse events during the study period were recorded and their relationships to the drugs were assessed.
Neuropsychiatric sequelae seemed to take a natural recovery course in patients with traumatic brain injury. Methylphenidate had significant effects on depressive symptoms compared with the placebo, without hindering the natural recovery process of cognitive function. Although sertraline also had significant effects on depressive symptoms compared with the placebo, it did not improve many tests on cognitive performances. Daytime sleepiness was reduced by methylphenidate, while it was not by sertraline.
Methylphenidate and sertraline had similar effects on depressive symptoms. However, methylphenidate seemed to be more beneficial in improving cognitive function and maintaining daytime alertness. Methylphenidate also offered a better tolerability than sertraline.
本研究旨在调查哌甲酯和舍曲林与安慰剂相比,对创伤性脑损伤(TBI)相关的各种神经精神后遗症的影响。
这是一项为期4周的双盲平行组试验。30例轻度至中度TBI患者被随机分配到三个治疗组之一(每组n = 10),三组在年龄、性别和教育程度上相匹配,即哌甲酯组(起始剂量为5mg/天,1周内增至20mg/天)、舍曲林组(起始剂量为25mg/天,1周内增至100mg/天)或安慰剂组。在基线和4周终点时,进行了以下评估:抑郁的主观(贝克抑郁量表)和客观(汉密尔顿抑郁评定量表)测量;用于评估脑震荡后症状的Rivermead脑震荡后症状问卷;用于评估生活质量的史克必成生活质量量表;七项性能测试(临界闪烁融合、选择反应时间、连续追踪、心算、短期记忆、数字符号替换和简易精神状态检查);睡眠的主观测量(利兹睡眠评估问卷)和日间嗜睡的主观测量(爱泼华嗜睡量表)。记录研究期间的所有不良事件,并评估其与药物的关系。
创伤性脑损伤患者的神经精神后遗症似乎呈现自然恢复过程。与安慰剂相比,哌甲酯对抑郁症状有显著影响,且不妨碍认知功能的自然恢复过程。虽然与安慰剂相比,舍曲林对抑郁症状也有显著影响,但它并未改善许多认知表现测试。哌甲酯可减轻日间嗜睡,而舍曲林则无此作用。
哌甲酯和舍曲林对抑郁症状有相似的影响。然而,哌甲酯似乎在改善认知功能和维持日间警觉性方面更有益。哌甲酯的耐受性也优于舍曲林。