Efficacy and safety of NABOTA in post-stroke upper limb spasticity: A phase 3 multicenter, double-blinded, randomized controlled trial

被引：31

作者：

Nam, Hyung Seok ^{[1
,2
]}

Park, Yoon Ghil ^{[3
,4
]}

Paik, Nam-Jong ^{[5
,6
]}

Oh, Byung-Mo ^{[5
,7
]}

Chun, Min Ho ^{[8
]}

Yang, Hea-Eun ^{[3
,4
]}

Kim, Dae Hyun ^{[3
,4
]}

Yi, Youbin ^{[5
,6
,7
]}

Seo, Han Gil ^{[5
,7
]}

Kim, Kwang Dong ^{[5
,7
]}

Chang, Min Cheol ^{[8
,9
]}

Ryu, Jae Hak ^{[10
]}

Lee, Shi-Uk ^{[5
]}

机构：

[1] Seoul Natl Univ, Boramae Med Ctr, Dept Rehabil Med, Seoul 158756, South Korea

[2] Seoul Natl Univ, Coll Med, Dept Biomed Engn, Seoul 158756, South Korea

[3] Yonsei Univ, Coll Med, Dept Rehabil Med, Seoul, South Korea

[4] Yonsei Univ, Coll Med, Rehabil Inst Neuromuscular Dis, Seoul, South Korea

[5] Seoul Natl Univ, Coll Med, Dept Rehabil Med, Seoul 158756, South Korea

[6] Seoul Natl Univ, Bundang Hosp, Dept Rehabil Med, Songnam, South Korea

[7] Seoul Natl Univ Hosp, Dept Rehabil Med, Seoul 110744, South Korea

[8] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Rehabil Med, Seoul, South Korea

[9] Union Hosp, Dept Phys Med & Rehabil, Daegu, South Korea

[10] Daewoong Pharmaceut, Clin Res Team, Seoul, South Korea

来源：

JOURNAL OF THE NEUROLOGICAL SCIENCES | 2015年 / 357卷 / 1-2期

关键词：

Stroke; Spasticity; Upper limb; Botulinum toxin A; Efficacy; Safety; TOXIN TYPE-A; PLACEBO-CONTROLLED TRIAL; BOTULINUM-TOXIN; STROKE; DISABILITY; NEUROTOXIN; PREVALENCE; IMPACT;

D O I：

10.1016/j.jns.2015.07.028

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

100204 [神经病学];

摘要：

Botulinum toxin A is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. Efficacy and safety of a new botulinum toxin type A, NABOTA (DWP450) in post-stroke upper limb spasticity was evaluated in comparison with Botox (onabotulinum toxin A). A total of 197 patients with post-stroke upper limb spasticity were included in this study and randomly assigned to NABOTA group (n = 99) or Botox group (n = 98). Wrist flexors with modified Ashworth Scale (MAS) grade 2 or greater, and elbow flexors, thumb flexors and finger flexors with MAS 1 or greater were injected with either drug. The primary outcome was the change of wrist flexor MAS between baseline and 4 weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12 weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12 weeks. The change of MAS for wrist flexor between baseline and 4 weeks post-injection was - 1.44 +/- 0.72 in the NABOTA group and - 1.46 +/- 0.77 in the Botox group. The difference of change between both groups was 0.0129 (95% confidence interval - 0.2062-0.2319), within the non-inferiority margin of 0.45. Both groups showed significant improvements regarding MAS of all injected muscles, DAS, and Caregiver Burden Scale at all follow-up periods. There were no significant differences in all secondary outcome measures between the two groups. NABOTA demonstrated non-inferior efficacy and safety for improving upper limb spasticity in stroke patients compared to Botox. (C) 2015 Elsevier B.V. All rights reserved.

引用

页码：192 / 197

页数：6

共 17 条

[1]

Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial [J].