Loubser P G, Narayan R K, Sandin K J, Donovan W H, Russell K D
Institute for Rehabilitation and Research, Baylor College of Medicine, Houston, Texas 77030.
Paraplegia. 1991 Jan;29(1):48-64. doi: 10.1038/sc.1991.7.
The effects of intrathecal baclofen infusion were studied in 9 spinal cord injury patients whose spasticity had been refractory to oral medications. In a two stage, placebo controlled trial, baclofen was administered into the lumbar intrathecal space and subsequent clinical and neurophysiologic changes were assessed. In stage 1, 9 patients underwent a 5 day percutaneous infusion of baclofen and placebo via an external pump. Ashworth and reflex scores were assessed at time of enrollment, after infusion of that amount of baclofen which provided optimal spasticity control and after intrathecal infusion of placebo. The mean Ashworth grade decreased from 3.78 +/- 1.34 to 1.16 +/- 0.48 (p less than 0.001) while mean reflex score decreased from 3.57 +/- 1.05 to 0.64 +/- 0.87 (p less than 0.001). These values differed significantly from those associated with placebo therapy (Ashworth grade--2.54 +/- 1.04, p less than 0.001; reflex score--2.56 +/- 1.04, p less than 0.01). Objective improvements in functional abilities and independence were noted in 8 patients, while somatosensory and brainstem auditory evoked potentials were unchanged in all patients. Urodynamic evaluation revealed increased bladder capacity in 3 patients, while in 4 no change was observed. In Stage 2, permanent programmable infusion pumps were implanted in 7 patients who demonstrated a good response during Stage 1. In this group, mean Ashworth score decreased from 3.79 +/- 0.69 to 2 +/- 0.96 (p less than 0.001) and mean reflex score decreased from 3.85 +/- 0.62 to 2.18 +/- 0.43 (p less than 0.001). Baclofen dosage increased from 182 +/- 135 to 528 +/- 266 mcg/day over the 3-22 month follow-up period. Most of the dosage increase occurred within the initial 12 months following infusion pump implantation and tended to plateau thereafter. Minor complications such as catheter dislodgement/kinking and nausea occurred infrequently while no device related infections were observed. There was no clinical evidence of any significant baclofen neurotoxicity either in Stage 1 or 2. The only ambulatory patient developed marked lower extremity weakness during Stage 1 intrathecal baclofen infusion and was temporarily unable to walk. We conclude that continuous administration of intrathecal baclofen is an effective and safe modality for spasticity control in patients who are refractory to oral medications.
对9例脊髓损伤后痉挛状态对口服药物治疗无效的患者，研究鞘内注射巴氯芬的效果。在一项分两阶段的、安慰剂对照试验中，将巴氯芬注入腰椎鞘内间隙，随后评估临床和神经生理学变化。在第1阶段，9例患者通过外置泵接受为期5天的巴氯芬和安慰剂经皮输注。在入组时、输注能提供最佳痉挛控制效果的巴氯芬量后以及鞘内输注安慰剂后，评估Ashworth评分和反射评分。平均Ashworth分级从3.78±1.34降至1.16±0.48（p<0.001），而平均反射评分从3.57±1.05降至0.64±0.87（p<0.001）。这些值与安慰剂治疗相关的值有显著差异（Ashworth分级——2.54±1.04，p<0.001；反射评分——2.56±1.04，p<0.01）。8例患者的功能能力和独立性有客观改善，而所有患者的体感诱发电位和脑干听觉诱发电位均无变化。尿动力学评估显示3例患者膀胱容量增加，4例患者无变化。在第2阶段，7例在第1阶段显示良好反应的患者植入了永久性可编程输注泵。该组患者的平均Ashworth评分从3.79±0.69降至2±0.96（p<0.001），平均反射评分从3.85±0.62降至2.18±0.43（p<0.001）。在3至22个月的随访期内，巴氯芬剂量从182±135微克/天增加至528±266微克/天。大部分剂量增加发生在输注泵植入后的最初12个月内，此后趋于平稳。导管移位/扭结和恶心等轻微并发症很少发生，未观察到与装置相关的感染。在第1阶段和第2阶段均无临床证据表明存在任何显著的巴氯芬神经毒性。唯一能行走的患者在第1阶段鞘内注射巴氯芬期间出现明显的下肢无力，暂时无法行走。我们得出结论，对于口服药物治疗无效的患者，持续鞘内注射巴氯芬是控制痉挛状态的一种有效且安全的方法。
