METHODS: Prospective, multicentre, post-marketing observational study. The study period was 16 months. The primary effectiveness variable was the mean change from baseline on the pain 0-10 Numerical Rating Scale after four botulinumtoxinA injection cycles. Secondary endpoints included changes from baseline on the pain 0-100 Visual Analogue Scale, Goal Attainment Scale, modified Ashworth Scale, 10-Meter Walk Test, Penn Spasm Frequency Scale, and 36-item Short-Form Health Survey.
RESULTS: Of 186 enrolled patients, 180 (96.8%) received botulinumtoxinA at least once. The mean (standard deviation) pain 0-10 Numerical Rating Scale score decreased significantly (p<0.0001) from 4.9 (2.2) at baseline to 2.5 (2.1) at study end, representing a 50% decrease in pain severity. Relief of pain due to spasticity was supported by improvement from baseline in all secondary variables except the 10-Meter Walk Test. Two adverse events (erysipelas and phlebitis) in one patient were considered likely to be related to botulinumtoxinA injection.
CONCLUSIONS: BotulinumtoxinA appears to provide pain relief as an additional benefit of local treatment in patients with post-stroke lower limb spasticity for whom pain relief is a primary therapeutic goal (a Lay Abstract has been provided as Appendix A).
方法:前瞻性,多中心,上市后观察性研究。研究期为16个月。主要有效性变量是四个肉毒杆菌毒素A注射周期后疼痛0-10数值评定量表相对于基线的平均变化。次要终点包括疼痛0-100视觉模拟评分的基线变化,目标达成量表,改良的Ashworth量表,10米步行测试,Penn痉挛频率量表,和36项短期健康调查。
结果:在186名患者中,180(96.8%)至少接受了一次肉毒杆菌毒素A。平均(标准差)疼痛0-10数值评定量表评分从基线时的4.9(2.2)显着降低(p<0.0001)至研究结束时的2.5(2.1),表示疼痛严重程度降低50%。除10米步行测试外,所有次要变量的基线改善都支持了由于痉挛引起的疼痛的缓解。一名患者的两个不良事件(丹毒和静脉炎)被认为可能与肉毒杆菌毒素A注射有关。
结论:肉毒杆菌毒素A似乎可以缓解疼痛,作为局部治疗中风后下肢痉挛的患者的额外益处,疼痛缓解是其主要治疗目标(《LayAbstract》见附录A)。