Article

OBJECTIVE: To investigate a new botulinum neurotoxin type A, termed
letibotulinumtoxinA(Botulax(R)) and compare its efficacy and safety for
post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox(R)).
DESIGN: A prospective, double-blinded, multicenter, randomized controlled
clinical study. SETTING: Six university hospitals in Korea. SUBJECTS: A total of
187 stroke participants with upper limb spasticity. INTERVENTIONS: Two kinds of
botulinum neurotoxin type A were used. One set of injection was performed and
total injected doses were 309.21+/-62.48U(Botulax) and 312.64+/-49.99U(Botox)(
P>0.05). MAIN MEASURES: Primary outcome was measured using the modified Ashworth
scale for wrist flexors at week 4 and secondary outcome was measured using
modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and
thumb flexors as well as Global Assessment in spasticity, Disability Assessment
Scale, and Caregiver Burden Scale. Safety measures including adverse events,
vital signs and physical examination, and laboratory tests were also monitored.
RESULTS: The mean ages for the Botulax group were 56.81+/-9.49 and which for the
Botox group were 56.93+/-11.93( P>0.05). In primary outcome, the change in
modified Ashworth scale for wrist flexors was -1.45+/-0.61 in the Botulax group
and -1.40+/-0.57 in the Botox group, and the difference between the two groups
was -0.06(95% CI:-0.23-0.12, P>0.05). In secondary outcome, both groups
demonstrated significant improvements with respect to modified Ashworth scale,
Global Assessment in spasticity, Disability Assessment Scale, and Caregiver
Burden Scale ( P<0.05), and no significant difference was observed between the
two groups ( P>0.05). In addition, safety measures showed no significant
differences between the two groups ( P>0.05). CONCLUSIONS: The efficacy and
safety of Botulax were comparable with those of Botox in treatment of post-stoke
upper limb spasticity.

Langue : ANGLAIS