Faculty of Medicine and Dentistry and University Hospital, Palacký University Olomouc, Olomouc, Czech Republic. E-mail:
J Rehabil Med. 2021 Jan 5;53(1):jrm00138. doi: 10.2340/16501977-2760.
This post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity.
Data from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled.
Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed.
Among 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation) AS arm sumscore improved continuously: main period, -3.23 (2.55) (placebo, -1.49 (2.09)); extension cycles 1, 2, and 3, -4.38 (2.85), -4.87 (3.05), and -5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles.
IncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb post-stroke spasticity.
本事后分析评估了重复使用依库珠单抗毒素 A 注射对脑卒中后上肢痉挛患者肌肉张力、残疾和照护者负担的影响。
汇总了两项 3 期、双盲、安慰剂对照主要期和三个开放标签扩展周期的多中心随机临床试验的数据。
受试者每 12 周（±3 天）（研究 3001，NCT01392300）或根据临床需要每 ≥12 周（研究 0410，NCT00432666）接受 400 单位依库珠单抗毒素 A 注射。采用 Ashworth 量表（AS）手臂总分（屈肘、腕、指和拇指肌以及前臂旋前肌 AS 评分之和）、残疾评估量表（DAS）和照护者负担量表（CBS）评分进行评估。
在 465 例受试者中，从研究基线到注射后 4 周，AS 手臂总分持续改善：主要期为-3.23（2.55）（安慰剂为-1.49（2.09））；扩展周期 1、2 和 3 分别为-4.38（2.85）、-4.87（3.05）和-5.03（3.02）。DAS 主要目标域应答率从主要期的 47.4%（安慰剂为 27.2%）增加到扩展周期 3 的 66.6%。所有周期中，CBS 评分在注射后 4 周时显著改善，伴随功能残疾的改善。
依库珠单抗毒素 A 可使脑卒中后上肢痉挛患者的肌肉张力、残疾和照护者负担持续改善。
