Azouvi P, Mane M, Thiebaut J B, Denys P, Remy-Neris O, Bussel B
Department of Neurological Rehabilitation, Raymond Poincaré Hospital, Garches, France.
Arch Phys Med Rehabil. 1996 Jan;77(1):35-9. doi: 10.1016/s0003-9993(96)90217-8.
To assess long-term efficacy and functional benefits of intrathecal baclofen for severe spinal spasticity.
A prospective before-after trial.
A neurological rehabilitation department of a university hospital. Pump implantation was realized in neurosurgery; follow-up was carried out mostly on an outpatient basis.
Eighteen patients with severe and disabling spinal spasticity received intrathecal baclofen by an implantable pump; average follow-up was 37.4 months (range, 9 to 72).
Spasticity (Ashworth and spasms frequency scores); disability (Functional Independence Measure [FIM]).
A significant decrease in tone and spasms was observed in all patients. Tolerance appeared during the first 6 to 9 months. Later on, efficacy remained stable, except in cases of mechanical problems of the pump or catheter. Functional assessment found a highly significant (p < .001) increase of FIM score (particularly for bathing, dressing lower body, transfers, and in some cases, locomotion). This was particularly marked in patients with thoracic spinal cord lesion. In cases of severe upper limb dysfunction, FIM was only improved for wheelchair displacements, due to a better sitting position, but nursing became easier and life comfort was enhanced. Severe side effects (overdose) were observed in two cases.
Efficacy remained stable after 6 to 9 months. Marked improvement of functional independence was observed in paraplegic patients. Improvement was less spectacular in patients with severe upper limb dysfunction, but nevertheless appreciable in terms of life comfort and use of attendants.
评估鞘内注射巴氯芬治疗严重脊髓痉挛的长期疗效和功能益处。
一项前瞻性前后对照试验。
一家大学医院的神经康复科。泵植入在神经外科进行;随访主要在门诊进行。
18例严重且致残的脊髓痉挛患者通过植入式泵接受鞘内注射巴氯芬;平均随访37.4个月(范围9至72个月)。
痉挛(Ashworth评分和痉挛频率评分);残疾程度(功能独立性测量[FIM])。
所有患者的肌张力和痉挛均显著降低。耐受性在最初6至9个月出现。此后,除泵或导管出现机械问题的情况外,疗效保持稳定。功能评估发现FIM评分显著提高(p <.001)(特别是在洗澡、下半身穿衣、转移以及某些情况下的行走方面)。这在胸段脊髓损伤患者中尤为明显。在严重上肢功能障碍的病例中,由于坐姿改善,FIM仅在轮椅移动方面有所改善,但护理变得更容易,生活舒适度提高。观察到2例严重副作用(过量)。
6至9个月后疗效保持稳定。截瘫患者的功能独立性有显著改善。严重上肢功能障碍患者的改善不太显著,但在生活舒适度和护理人员使用方面仍相当可观。