RESUMO
A multicenter review of the medical records of Japanese post-stroke patients with spastic hemiplegia was conducted to investigate the clinical use of botulinum toxin type A (BoNT/A) by physicians with expertise in the treatment of upper and lower limb spasticity. An analysis of the data from 307 patients treated with BoNT/A during the period January 1, 2012 to November 30, 2013 provided a variety of information on factors relating to BoNT/A injection outcomes, including the total dose of BoNT/A per treatment session, the dose of BoNT/A per muscle, the number of injection sites per muscle, the method used to locate the muscles to be injected, and the dilution of reconstituted BoNT/A. Our analysis indicated that the dose of BoNT/A administered per muscle was usually selected by taking into consideration the severity of spasticity, rather than the patient's body size. Since the technical expertise of experienced clinicians is summarized in this data, it may serve as a useful reference for the use of BoNT/A in routine clinical practice.
RESUMO
Objective : To evaluate the efficacy and safety of botulinum toxin type A (BTXA) in Japanese patients with post-stroke upper limb spasticity in a multicenter, randomized, double-blind, single dose, placebo-controlled study (double-blind phase) followed by an open-label, multiple dose extension (open-label phase). Methods : One hundred and nine patients with upper limb spasticity were randomized to receive a single treatment with either a lower dose (120-150 Units ; U), higher dose (200-240U) BTXA or placebo into upper limb muscles in the double-blind phase. These treatments were administered to improve wrist and finger flexion for all patients and thumb flexion in patients with thumb spasticity. Patients who met the re-injection criteria received up to 3 repeated treatments of BTXA (200-240U) into their upper limb muscles with at least 12 weeks between treatments in the open-label phase through 48 weeks. Results : In the double-blind phase there was significant improvement from baseline spasticity on the Modified Ashworth Scale (MAS) wrist score between the higher dose BTXA and placebo groups, with a mean difference in the area under the curve (AUC) of -6.830 (<i>p</i><0.001, t test). The MAS wrist score further decreased from baseline in all repeat treatment cycles of BTXA in the open-label phase. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BTXA-treated and placebo-treated patients during the study period. Conclusions : BTXA injections reduced spasticity in the upper limb muscles from the first treatment with continued long-term efficacy. Our results suggest that BTXA injections are safe and effective for the long-term treatment of post-stroke upper limb spasticity.
RESUMO
Objective : To evaluate the efficacy and safety of botulinum toxin type A (BTXA) in Japanese patients with post-stroke lower limb spasticity in a multicenter, randomized, double-blind, single dose, placebo-controlled study (double-blind phase) followed by an open-label, multiple dose extension (open-label phase). Methods : One hundred and twenty patients with lower limb spasticity were randomized to receive a single treatment with BTXA 300 Units (U) or placebo into lower limb muscles in the double-blind phase. Patients who met the re-injection criteria received up to 3 repeated treatments of BTXA into lower limb muscles with at least 12 weeks between treatments in the open-label phase through 48 weeks. Results : In the double-blind phase there was significant improvement from baseline spasticity in the Modified Ashworth Scale (MAS) ankle score between the BTXA 300U and placebo groups, with a mean difference in the area under the curve (AUC) of -3.428 (<i>p</i>=0.006, t test). The MAS ankle score further decreased from baseline in all repeat treatment cycles of BTXA in the open-label phase. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BTXA-treated and placebo-treated patients during the study period. Conclusions : BTXA reduced spasticity in lower limb muscles from the first treatment with continued long-term efficacy. BTXA is safe and effective for the long-term treatment of post-stroke lower limb spasticity.