Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.
Toxins (Basel). 2022 Oct 25;14(11):730. doi: 10.3390/toxins14110730.
Botulinum toxin type A (BTX-A) is widely used for treating post-stroke upper limb spasticity. We evaluated the safety and efficacy of HU-014 in treating post-stroke upper limb spasticity. Thirteen patients were administered with HU-014. The primary outcome was safety, including adverse events, vital signs, physical examination, laboratory tests, and antibody formation test. The secondary outcomes were changes in the Modified Ashworth Scale (MAS) score for wrist, elbow, and finger flexor; Disability Assessment Scale (DAS); Investigator's Global Assessment (IGA) and Subject's Global Assessment (SGA); Caregiver Burden Scale (CBS); and Columbia Suicide Severity Rating Scale (C-SSRS) at weeks 4, 8, and 12 from baseline. No notable safety-related issues were reported. MAS and DAS scores were significantly decreased from those at baseline at 4, 8, and 12 weeks ( < 0.05). At weeks 4, 8, and 12, the IGA and SGA scores were 5.85 ± 0.55, 5.69 ± 0.48, and 5.62 ± 0.65 and 5.46 ± 1.20, 5.85 ± 0.38, and 5.77 ± 0.73, respectively. CBS scores decreased at all timepoints and those for cutting fingernails significantly decreased at 8 and 12 weeks compared with baseline ( < 0.05). C-SSRS scores showed that suicidal ideation in all patients was "low" at all timepoints. HU-014 is a safe treatment that can improve post-stroke upper limb spasticity.
A型肉毒毒素（BTX-A）广泛用于治疗中风后上肢痉挛。我们评估了 HU-014 治疗中风后上肢痉挛的安全性和有效性。13 名患者接受了 HU-014 治疗。主要结局是安全性，包括不良反应、生命体征、体格检查、实验室检查和抗体形成试验。次要结局是基线后 4、8 和 12 周时腕、肘和手指屈肌的改良 Ashworth 量表（MAS）评分、残疾评估量表（DAS）、研究者总体评估（IGA）和受试者总体评估（SGA）、照顾者负担量表（CBS）和哥伦比亚自杀严重程度评定量表（C-SSRS）的变化。未报告明显的安全性问题。MAS 和 DAS 评分从基线开始在 4、8 和 12 周时显著降低（<0.05）。在第 4、8 和 12 周时，IGA 和 SGA 评分分别为 5.85±0.55、5.69±0.48 和 5.62±0.65 和 5.46±1.20、5.85±0.38 和 5.77±0.73。CBS 评分在所有时间点均下降，与基线相比，8 周和 12 周时修剪指甲的评分显著下降（<0.05）。C-SSRS 评分显示，所有患者在所有时间点的自杀意念均为“低”。HU-014 是一种安全的治疗方法，可以改善中风后上肢痉挛。
