Middel B, Kuipers-Upmeijer H, Bouma J, Staal M, Oenema D, Postma T, Terpstra S, Stewart R
Northern Centre for Health Care Research, Faculty of Medical Sciences, University of Groningen, the Netherlands.
J Neurol Neurosurg Psychiatry. 1997 Aug;63(2):204-9. doi: 10.1136/jnnp.63.2.204.
To compare clinical effectiveness and health related quality of life in patients with severe spasticity who received intrathecal baclofen or a placebo.
In a double blind, randomised, multicentre trial 22 patients were followed up during 13 weeks and subsequently included in a 52 week observational longitudinal study. Patients were those with chronic, disabling spasticity who did not respond to maximum doses of oral baclofen, dantrolene, and tizanidine. After implantation of a programmable pump patients were randomly assigned to placebo or baclofen infusion for 13 weeks. After 13 weeks all patients received baclofen. Clinical efficacy was assessed by the Ashworth scale, spasm score, and self reported pain, and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL).
At three months the scores of the placebo and baclofen group differed slightly for the spasm score (effect size=0.20) and substantially for the Ashworth scale (effect size=1.40) and pain score (effect size=0.94); health related quality of life showed no significant differences. Three months after implantation the baclofen group showed a significant, substantial improvement on the SIP "physical health", "mental health", "mobility", and "sleep and rest" subscales and on the HSCL mental health scale; patients receiving placebo showed no change. After one year of baclofen treatment significant (P<0.05) improvement was found on the SIP dimensions "mobility" and "body care and movement" with moderate effect sizes. Improvement on the SIP subscale "physical health" (P<0.05; effect size 0.86), the SIP overall score (without "ambulation"), and the "physical health" and overall scale of the HSCL was also significant, with effect sizes >0.80. Changes in health related behaviour were noted for "sleep and rest" and "recreation and pastimes" (P<0.01, P<0.05; effect size 0.95 and 0.63, respectively). Psychosocial behaviour showed no improvement.
Intrathecal baclofen delivered by an implanted, programmable pump resulted in improved self reported quality of life as assessed by the SIP, and HSCL physical health dimensions also suggest improvement.
比较接受鞘内注射巴氯芬或安慰剂的重度痉挛患者的临床疗效和健康相关生活质量。
在一项双盲、随机、多中心试验中，22例患者接受了为期13周的随访，随后纳入一项为期52周的观察性纵向研究。患者为慢性、致残性痉挛患者，对最大剂量的口服巴氯芬、丹曲林和替扎尼定无反应。在植入可编程泵后，患者被随机分配接受安慰剂或巴氯芬输注13周。13周后，所有患者均接受巴氯芬治疗。通过Ashworth量表、痉挛评分和自我报告的疼痛评估临床疗效，通过疾病影响概况（SIP）和霍普金斯症状清单（HSCL）评估健康相关生活质量。
三个月时，安慰剂组和巴氯芬组的痉挛评分差异较小（效应量=0.20），Ashworth量表（效应量=1.40）和疼痛评分差异较大（效应量=0.94）；健康相关生活质量无显著差异。植入后三个月，巴氯芬组在SIP的“身体健康”、“心理健康”、“活动能力”和“睡眠与休息”子量表以及HSCL心理健康量表上有显著的、实质性的改善；接受安慰剂的患者无变化。巴氯芬治疗一年后，在SIP维度“活动能力”和“身体护理与运动”上发现有显著（P<0.05）改善，效应量中等。SIP子量表“身体健康”（P<0.05；效应量0.86）、SIP总分（不包括“行走”）以及HSCL的“身体健康”和总体量表也有显著改善，效应量>0.80。在“睡眠与休息”和“娱乐与消遣”方面注意到健康相关行为的变化（P<0.01，P<0.05；效应量分别为0.95和0.63）。心理社会行为无改善。
通过植入式可编程泵给予鞘内巴氯芬可改善自我报告的生活质量，如通过SIP评估，HSCL身体健康维度也表明有所改善。
