Centro Catarinense de Reabilitação, Florianópolis, Santa Catarina 88025-301, Brazil.
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, São Paulo 14049-900, Brazil.
Toxins (Basel). 2020 Dec 4;12(12):770. doi: 10.3390/toxins12120770.
Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3-6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0-349) months, onset of spasticity and first injection was 22.7 (0-350) months and waiting time for a rehabilitation appointment was 9.0 (1-96) months. At visit 2, 61.3% (95% CI: 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI: 49.9, 65.3] vs. 64.1% [95% CI: 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.
A型肉毒毒素（BoNT-A）是治疗中风后痉挛的有效方法；然而，一些患者在中风后至少 1 年才能接受治疗。这项巴西上市后研究（NCT02390206）评估了 BoNT-A 注射后慢性中风后痉挛患者实现以患者为中心的目标的情况。患者在研究入组前有最后一次记录的中风≥1 年，且伴有或不伴有下肢（LL）痉挛的中风后上肢（UL）痉挛。患者在基线（访视 1）和访视 2（3-6 个月）时接受 BoNT-A 注射。主要终点是访视 2 时的应答率（目标实现量表（GAS）的主要目标的实现）。总体而言，204 例患者在访视 2 时接受了 GAS 评估，平均（SD）年龄为 56.4（13.2）岁，90.7%有 LL 痉挛。首次中风和痉挛发作之间的中位数（范围）时间为 3.6（0-349）个月，痉挛发作和首次注射之间的时间为 22.7（0-350）个月，康复预约的等待时间为 9.0（1-96）个月。在访视 2 时，61.3%（95%CI：54.4，67.7）的患者为应答者，UL 和 LL 的主要目标相似（57.8%[95%CI：49.9，65.3]与 64.1%[95%CI：48.4，77.3]）。这项研究提供了证据支持 BoNT-A 治疗慢性中风后痉挛的有效性。
