Lewis K S, Mueller W M
Department of Surgery, Medical College of Wisconsin, Milwaukee 53226.
Ann Pharmacother. 1993 Jun;27(6):767-74. doi: 10.1177/106002809302700618.
To evaluate the use of intrathecal baclofen for the treatment of muscle spasticity in patients with spinal cord injury.
A MEDLINE search was used to identify relevant and pertinent literature. Information was obtained from open-label clinical trials, abstracts, conference proceedings, and review articles. Index terms in the search included baclofen, spasticity, intrathecal drug infusion, spinal cord disease, and neurosurgery.
Studies were selected for review if they evaluated intrathecal baclofen in patients with spinal cord injury. Emphasis was placed on human studies published in the English language. Trials were reviewed by dosage regimen, therapeutic response, adverse effects, and complications.
Thus far, intrathecal baclofen administration shows promise in the treatment of spasticity resulting from spinal cord trauma. Few complications and adverse effects have been reported.
Muscle spasms and spasticity constitute a significant problem in spinal cord injuries, interfering with rehabilitation and leading to inconveniences and complications in these patients. Oral baclofen is the drug of choice for spasticity due to spinal cord trauma. It often is ineffective, however, because of the large dosages required to cross the blood-brain barrier and the subsequent appearance of central nervous system adverse effects. These adverse effects are not tolerated by many patients. Intrathecally administered baclofen has been approved by the Food and Drug Administration (FDA) for the treatment of spasticity in patients with spinal cord injury who are refractory to or cannot tolerate oral baclofen. It is intended for use only in implantable pumps approved by the FDA for the administration of baclofen into the intrathecal space. Intrathecal administration achieves high concentrations in the spinal cord with small dosages, thus reducing the incidence of central nervous system adverse effects. To date, approximately 350 patients with spinal cord injury have been treated with intrathecal baclofen. Reductions in spasticity have been demonstrated in both open-label and placebo-controlled trials. Patients also often make substantial gains in activities of daily living. Few adverse effects and complications have been reported. However, tolerance to the clinical effects of intrathecal baclofen has been reported. Further studies are needed to determine specific patient populations that may benefit most from intrathecal baclofen administration. Individual dosage ranges and follow-up care also need to be defined more completely. In addition, the question of whether tolerance detracts from long-term clinical benefits with intrathecal baclofen needs to be addressed.
评估鞘内注射巴氯芬治疗脊髓损伤患者肌肉痉挛的效果。
通过医学文献数据库（MEDLINE）检索相关文献。信息来源于开放标签临床试验、摘要、会议论文集及综述文章。检索词包括巴氯芬、痉挛、鞘内药物输注、脊髓疾病和神经外科。
若研究评估了脊髓损伤患者鞘内注射巴氯芬，则入选进行综述。重点关注英文发表的人体研究。根据给药方案、治疗反应、不良反应和并发症对试验进行综述。
迄今为止，鞘内注射巴氯芬在治疗脊髓创伤所致痉挛方面显示出前景。报道的并发症和不良反应较少。
肌肉痉挛在脊髓损伤中是一个重要问题，干扰康复并给这些患者带来不便和并发症。口服巴氯芬是脊髓创伤所致痉挛的首选药物。然而，由于需要大剂量才能穿过血脑屏障且随后会出现中枢神经系统不良反应，它往往无效。许多患者无法耐受这些不良反应。鞘内注射巴氯芬已获美国食品药品监督管理局（FDA）批准，用于治疗对口服巴氯芬难治或不耐受的脊髓损伤患者的痉挛。仅适用于FDA批准用于将巴氯芬注入鞘内空间的植入式泵。鞘内给药小剂量即可在脊髓中达到高浓度，从而降低中枢神经系统不良反应的发生率。迄今为止，约350例脊髓损伤患者接受了鞘内注射巴氯芬治疗。开放标签试验和安慰剂对照试验均显示痉挛有所减轻。患者在日常生活活动方面通常也有显著改善。报道的不良反应和并发症较少。然而，已有对鞘内注射巴氯芬临床效果产生耐受的报道。需要进一步研究以确定可能从鞘内注射巴氯芬给药中获益最大的特定患者群体。还需要更全面地确定个体给药范围和后续护理。此外，耐受是否会降低鞘内注射巴氯芬的长期临床益处这一问题也需要解决。
