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ID 118076
Author
Kaji, Ryuji Tokushima University|National Hospital Organization Utano Hospital Tokushima University Educator and Researcher Directory KAKEN Search Researchers
Furumoto, Taiki Tokushima University
Takeuchi, Toshiaki Tokushima University|National Hospital Organization Utano Hospital
Kohda, Tomoko Osaka Metropolitan University
Kozaki, Shunji Osaka Metropolitan University
Keywords
botulinum neurotoxin
subtype A2
A2NTX
onabotulinumtoxinA
clinical efficacy
safety
spasticity: modified Ashworth scale
Functional Independence Measure
hand grip
spread
Content Type
Journal Article
Description
All the currently used type A botulinum neurotoxins for clinical uses are of subtype A1. We compared the efficacy and safety for the first time head-to-head between a novel botulinum toxin A2NTX prepared from subtype A2 and onabotulinumtoxinA (BOTOX) derived from A1 for post-stroke spasticity. We assessed the modified Ashworth scale (MAS) of the ankle joint, the mobility scores of Functional Independence Measure (FIM), and the grip power of the unaffected hand before and after injecting 300 units of BOTOX or A2NTX into calf muscles. The procedure was done in a blinded manner for the patient, the injecting physician, and the examiner. Stroke patients with chronic spastic hemiparesis (15 for A2NTX and 16 for BOTOX) were enrolled, and 11 for A2NTX and 13 for BOTOX (MAS of ankle; > or = 2) were entered for the MAS study. Area-under-curves of changes in MAS (primary outcome) were greater for A2NTX by day 30 (p = 0.044), and were similar by day 60. FIM was significantly improved in the A2NTX group (p = 0.005), but not in the BOTOX group by day 60. The hand grip of the unaffected limb was significantly decreased in the BOTOX-injected group (p = 0.002), but was unaffected in the A2NTX-injected group by day 60, suggesting there was less spread of A2NTX to the upper limb than there was with BOTOX. Being a small-sized pilot investigation with an imbalance in the gender of the subjects, the present study suggested superior efficacy and safety of A2NTX, and warrants a larger scale clinical trial of A2NTX to confirm these preliminary results.
Journal Title
Toxins
ISSN
20726651
Publisher
MDPI
Volume
14
Issue
11
Start Page
739
Published Date
2022-10-28
Rights
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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DOI (Published Version)
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language
eng
TextVersion
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departments
Medical Sciences
University Hospital