کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8275539 | 1535105 | 2015 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Efficacy and safety of NABOTA in post-stroke upper limb spasticity: A phase 3 multicenter, double-blinded, randomized controlled trial
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کلمات کلیدی
DASFASPps - PPSEfficacy - اثرSpasticity - اسپاستیسیته یا اسپاستیسیتی modified Ashworth scale - اصلاح مقیاس AshworthUpper limb - اندام زبرین، اندام فوقانیSafety - ایمنیMAS - بیشترfull analysis set - تجزیه و تحلیل کامل مجموعهper protocol set - در هر پروتکل مجموعهbotulinum toxin A - سم بوتولینوم AStroke - سکته مغزیGlobal assessment scale - مقیاس ارزیابی جهانیGas - گاز
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
سالمندی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
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 â 1.44 ± 0.72 in the NABOTA group and â 1.46 ± 0.77 in the Botox group. The difference of change between both groups was 0.0129 (95% confidence interval â 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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of the Neurological Sciences - Volume 357, Issues 1â2, 15 October 2015, Pages 192-197
Journal: Journal of the Neurological Sciences - Volume 357, Issues 1â2, 15 October 2015, Pages 192-197
نویسندگان
Hyung Seok Nam, Yoon Ghil Park, Nam-Jong Paik, Byung-Mo Oh, Min Ho Chun, Hea-Eun Yang, Dae Hyun Kim, Youbin Yi, Han Gil Seo, Kwang Dong Kim, Min Cheol Chang, Jae Hak Ryu, Shi-Uk Lee,