Division of Physical Medicine and Rehabilitation (Drs Kurowski, Pruitt, and Wade), Division of Behavioral Medicine and Clinical Psychology (Dr Epstein), Division of Neurology (Dr Horn), and Division of Biostatistics and Epidemiology (Dr Altaye), Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; and Departments of Pediatrics and Neurology and Rehabilitation Medicine (Drs Kurowski and Pruitt) and Department of Pediatrics (Drs Epstein, Horn, Altaye, and Wade), University of Cincinnati College of Medicine, Cincinnati, Ohio.
J Head Trauma Rehabil. 2019 Mar/Apr;34(2):E1-E12. doi: 10.1097/HTR.0000000000000432.
To characterize the benefits and optimal dose of long-acting methylphenidate for management of long-term attention problems after childhood traumatic brain injury (TBI).
Phase 2, randomized, double-masked, placebo-controlled, dose-titration, crossover clinical trial.
Outpatient, clinical research.
Twenty-six children aged 6 to 17 years who were at least 6 months post-TBI and met criteria for attention-deficit hyperactivity disorder (ADHD) at the time of enrollment.
Vanderbilt Rating Scale of attention problems, Pittsburgh Side Effects Rating Scale, and vital signs.
Among the 26 participants randomized, 20 completed the trial. The mean ages at injury and enrollment were 6.3 and 11.5 years, respectively. Eight participants had a severe TBI. On an optimal dose of medication, greater reductions were found on the Vanderbilt Parent Rating Scale for the medicated condition than for placebo (P = .022, effect size = 0.59). The mean optimal dose of methylphenidate was 40.5 mg (1.00 mg/kg/day). Preinjury ADHD diagnosis status was not associated with a differential medication response. Methylphenidate was associated with weight loss (∼1 kg), increased systolic blood pressure (∼3- to 6-point increase), and mild reported changes in appetite.
Findings support use of long-acting methylphenidate for management of long-term attention problems after pediatric TBI. Larger trials are warranted of stimulant medications, including comparative effectiveness and combination medication and nonmedication interventions.
描述长效哌醋甲酯治疗儿童创伤性脑损伤（TBI）后长期注意问题的益处和最佳剂量。
2 期、随机、双盲、安慰剂对照、剂量滴定、交叉临床试验。
门诊，临床研究。
26 名年龄在 6 至 17 岁之间的儿童，在 TBI 后至少 6 个月，并且在入组时符合注意缺陷多动障碍（ADHD）标准。
范德比尔特注意力问题评定量表、匹兹堡不良反应评定量表和生命体征。
在随机分组的 26 名参与者中，有 20 名完成了试验。损伤和入组时的平均年龄分别为 6.3 岁和 11.5 岁。8 名参与者有严重的 TBI。在最佳药物剂量下，与安慰剂相比，服用药物的情况下范德比尔特父母评定量表的评分降低更为显著（P=0.022，效应量=0.59）。哌醋甲酯的平均最佳剂量为 40.5mg（1.00mg/kg/天）。受伤前 ADHD 诊断状态与药物反应无差异无关。哌醋甲酯与体重减轻（约 1kg）、收缩压升高（约 3-6 点升高）和轻度报告的食欲变化有关。
研究结果支持使用长效哌醋甲酯治疗儿童 TBI 后长期注意力问题。需要进行更大规模的兴奋剂药物试验，包括比较有效性和联合药物及非药物干预。
