Clearfield Jacob S, Nelson Mary Elizabeth S, McGuire John, Rein Lisa E, Tarima Sergey
Medical College of Wisconsin, Milwaukee, WI, USA.
Neuromodulation. 2016 Aug;19(6):642-9. doi: 10.1111/ner.12361. Epub 2015 Oct 30.
To examine dosing patterns in patients receiving baclofen via intrathecal baclofen pumps to assess for common patterns by diagnosis, ambulation ability, and affected limbs distribution.
This trial study included 25 patients with baclofen pumps selected from the 356 patients enrolled in our center's baclofen pump program. Selection was done by splitting all patients into diagnostic categories of stroke, multiple sclerosis, traumatic/anoxic brain injury, cerebral palsy, and spinal cord injury, and then, five patients were randomly selected from each diagnosis.A systematic chart review was then conducted for each patient from Jan 1, 2008, through September 16, 2013, to look at factors including mean daily dose at end of study, and among those implanted during the study mean initial stable dose and time to initial stable dose.
Analysis of mean daily dose across diagnoses found significant differences, with brain injury, cerebral palsy, and spinal cord injury patients having higher doses while multiple sclerosis and stroke patients required lower doses. Nonambulatory patients strongly trended to have higher daily doses than ambulatory patients. Similar trends of mean initial stable dose being higher in a similar pattern as that of end mean daily dose were seen according to diagnoses and ambulatory status, although statistical significance could not be achieved with the small sample size.
Significant differences in dosing were found between diagnoses and trended to differ by ambulatory status at the end of the study, and similar trends could be observed in achieving initial stable dose.
研究通过鞘内注射巴氯芬泵接受巴氯芬治疗的患者的给药模式,以根据诊断、行走能力和受累肢体分布评估常见模式。
本试验研究纳入了从我们中心巴氯芬泵项目登记的356例患者中选取的25例使用巴氯芬泵的患者。选取方法是将所有患者按中风、多发性硬化症、创伤性/缺氧性脑损伤、脑瘫和脊髓损伤的诊断类别进行划分,然后从每个诊断类别中随机选取5例患者。然后对每位患者从2008年1月1日至2013年9月16日进行系统的病历审查,以查看包括研究结束时的平均每日剂量,以及在研究期间植入的患者中的平均初始稳定剂量和达到初始稳定剂量的时间等因素。
对各诊断组平均每日剂量的分析发现存在显著差异,脑损伤、脑瘫和脊髓损伤患者的剂量较高,而多发性硬化症和中风患者所需剂量较低。非行走患者的每日剂量明显高于行走患者。根据诊断和行走状态,平均初始稳定剂量呈现出与最终平均每日剂量相似的较高趋势,尽管由于样本量小未能达到统计学显著性。
研究结束时,各诊断组之间在给药方面存在显著差异,且在行走状态方面也有差异趋势,在达到初始稳定剂量方面也可观察到类似趋势。