ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
Water Jet flow was projected at normal human aortic walls and human chronic obstructive iliac arteries in the air or in the ordinary saline solution. Ordinary saline solution was used for the jet, which was projected at a pressure of 10kg·f/cm<sup>2</sup> through a nozzle 0.10mm in diameter. When the Water Jet was projected at the normal aortic intima, damage to the wall was more severe with duration of fluid projection, and projection for ten sec ruprured the elastic fiber of the media. But when the fluid jet projected ordinary saline, damage to the aortic wall was slight and projection for 30sec only dissected the surface of the intima. Water Jet projection in air showed slight effect on thrombi of the chronic obstructive iliac arteries, and projection for 60sec only made small irregular holes in the thrombi. When the Water Jet was projected in ordinary saline solution, however, destructive effects on thrombi were stronger and the projection for 40sec could remove almost all the thrombi for a distance of 2cm, while damage to the initima was very slight. This study demonstrated that fluid jet projection using ordinary saline solution could remove thrombi in chronically obstructive artery safely and effectively and suggested the possibility of the Water Jet angioplasty.