Intrathecal baclofen for intractable cerebral spasticity: A prospective placebo-controlled, double-blind study
Intrathecal baclofen for intractable cerebral spasticity: A prospective placebo-controlled, double-blind study
复制标题
DOI：
10.1097/00006123-200003000-00017
复制
发表时间：
2000-03-01
期刊：
影响因子：
4.8
通讯作者：
Feys, P
中科院分区：
文献类型：
--
作者：
Van Schaeybroeck, P;Nuttin, B;Feys, P
目的：对鞘内注射和巴氯芬持续给药对重度脑源性痉挛患者功能参数的影响进行安慰剂对照的前瞻性研究。方法：对11例脑源性痉挛(主要是脑性瘫痪)患者，在包括安慰剂对照的团注试验中，对痉挛(Ashworth量表评分和视觉模拟评分)、痉挛、疼痛和功能能力进行双盲评分。8名患者被认为是良好的应答者，接受了鞘内给药的皮下装置。其中6名患者被随访2年，在此期间，他们接受了与团注后相同的评分程序。这些患者接受了盲法剂量减少测试。结果：在团注测试中，痉挛评分有明显的安慰剂效应。与这种安慰剂效应相比，鞘内注射的8名患者显示出显著的有益效果，大多数患者的功能都得到了改善。在持续输液期间，Ashworth量表评分不太有利，但仍显著低于基线。主观评价(视觉模拟评分)保持积极，功能保持改善，患者舒适度持续显著改善。结论：鞘内应用巴氯芬治疗脑源性痉挛是一种安全有效的治疗方法。功能有明显改善。在痉挛评分上存在安慰剂效应，这表明需要对每个患者进行双盲筛查。
OBJECTIVE: To conduct a placebo-controlled prospective study of the effectiveness of intrathecal bolus injections and continuous administration of baclofen on functional parameters in patients with severe spasticity of cerebral origin. To compare this functional evaluation with spasticity scores in different muscle groups.METHODS: In 11 patients with spasticity of cerebral origin (mainly cerebral palsy), double-blind scoring of spasticity (Ashworth scale score and visual analog score), spasms, pain, and functional abilities was performed during tests with bolus injections including a placebo control. Eight patients were considered good responders and received a subcutaneous device for intrathecal drug delivery. Six of these patients were followed up for 2 years, during which they underwent the same scoring procedures as after their bolus injections. These patients were subjected to a blinded dose reduction test.RESULTS: There was a noticeable placebo effect on spasticity scores during tests with bolus injections. Eight patients demonstrated a significant beneficial effect of intrathecal bolus injections compared with this placebo effect, Functional improvements were noted in most patients. During continuous infusion, Ashworth scale scores were less favorable but still significantly lower than at baseline. Subjective evaluation (visual analog scores) remained positive, functional improvements were maintained, and patient comfort was invariably and significantly improved.CONCLUSION: Intrathecal administration of baclofen is a safe and effective treatment for spasticity of cerebral origin. Functional improvement was demonstrated. The presence of a placebo effect on the spasticity scores suggests the need for double-blind screening in each patient.