Raymond-Poincaré Hospital, AP-HP, University of Versailles Saint Quentin, Boulevard Raymond Poincaré, 92380 Garches, France.
Department of Neurology, Vivantes Hospital Spandau, Neue Bergstaße, 13585 Berlin, Germany.
Ann Phys Rehabil Med. 2021 Mar;64(2):101376. doi: 10.1016/j.rehab.2020.03.005. Epub 2020 Apr 12.
Lower-limb spasticity can impair ambulation and gait, impacting quality of life.
This ancillary analysis of the TOWER study (NCT01603459) assessed the efficacy of incobotulinumtoxinA for lower-limb post-stroke spasticity including pes equinovarus.
Participants received escalating incobotulinumtoxinA doses (400-800U) across 3 injection cycles. Changes were compared for those treated in the lower limb (with/without upper-limb treatment) or the upper limb only or for participants treated or untreated for pes equinovarus. Outcome measures were those used in the seminal study: resistance to passive movement scale (REPAS), Ashworth Scale (AS), functional ambulation and lower-limb goal attainment.
Among 132/155 (85%) participants with post-stroke spasticity, in cycles 1, 2 and 3, 99, 119 and 121 participants received lower-limb treatment with mean (SD) total limb incobotulinumtoxinA doses of 189.2 (99.2), 257.1 (115.0) and 321.3 (129.2) U, respectively. Of these, 80, 105 and 107, respectively, were treated for pes equinovarus. The mean (SD) improvement in REPAS lower-limb score was greater with treatment in the lower limb versus the upper limb only: -1.6 (2.1) versus-0.4 (1.4); -1.9 (1.9) versus -0.6 (1.6); -2.2 (2.2) versus -1.0 (0.0) (P=0.0005, P=0.0133 and P=0.3581; analysis of covariance [ANCOVA], between-group differences) in cycles 1, 2 and 3, respectively. For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P=0.0099; ANCOVA). At the end of cycle 3, 42% of participants walked independently and 63% achieved 2 of 2 lower-limb treatment goals (baseline 23% and 34%, respectively).
This study supports the efficacy of incobotulinumtoxinA for treatment of pes equinovarus and other patterns of lower-limb post-stroke spasticity.
下肢痉挛可影响步行和步态，降低生活质量。
TOWER 研究（NCT01603459）的辅助分析评估了利鲁唑治疗下肢卒中后痉挛的疗效，包括马蹄内翻足。
参与者接受了 3 个周期的递增型利鲁唑治疗（400-800U）。对接受下肢（上肢治疗或不治疗）或上肢治疗或不治疗的参与者进行比较，以评估治疗效果。主要疗效终点为研究中使用的指标：被动运动阻力量表（REPAS）、Ashworth 量表（AS）、功能性步行和下肢目标实现。
在 155 名（85%）卒中后痉挛患者中，132 名患者接受了治疗，1、2 和 3 个周期分别有 99、119 和 121 名患者接受了下肢治疗，平均（SD）下肢总利鲁唑剂量分别为 189.2（99.2）、257.1（115.0）和 321.3（129.2）U。其中，80、105 和 107 名患者分别接受了马蹄内翻足治疗。与上肢治疗相比，下肢治疗的 REPAS 下肢评分改善更显著：-1.6（2.1）比-0.4（1.4）；-1.9（1.9）比-0.6（1.6）；-2.2（2.2）比-1.0（0.0）（P=0.0005、P=0.0133 和 P=0.3581；协方差分析[ANCOVA]，组间差异），分别在 1、2 和 3 个周期中。在所有周期中，与未接受马蹄内翻足治疗的患者相比，接受治疗的患者踝关节 AS 评分从注射到治疗后 4 周的平均改善更显著，第 1 周期的组间差异具有统计学意义（P=0.0099；ANCOVA）。在第 3 周期结束时，42%的患者能够独立行走，63%的患者实现了 2 个下肢治疗目标中的 2 个（基线时分别为 23%和 34%）。
本研究支持利鲁唑治疗马蹄内翻足和其他下肢卒中后痉挛模式的疗效。
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