| Summary: | 碩士 === 國立臺灣大學 === 預防醫學研究所 === 94 === Botulinum toxin A (BTX-A) has been shown to be an effective treatment of lower limb spasticity in children with cerebral palsy. BTX-A is an expensive and potentially toxic agent. Enhancing the efficacy of per unit dose by modifying drug preparation with higher diluent volumes is a potential options.
The object of this parallel randomized controlled study is to compare the effect of equivalent dose of BTX-A (Dysport®) in high-volume (500unit/5ml) and low-volume (500unit/1ml) injections on spastic gastrocnemius muscle in children with cerebral palsy. Twenty spastic diplegia and two spastic quadriplegia participated in the study. The children were randomized to receive high-volume preparation of BTX-A in one leg and low-volume preparation of BTX-A in the other leg. All children were assessed at baseline, four and eight weeks following injection. The analyzed parameters included dynamic and static ankle joint range of motion, area of the compound muscle action potential for gastrocnemius muscle, calf muscle tone .
The legs in high-volume preparation treatment showed significant increasing dynamic ankle joint ROM (P=0.0002), improvement of modified Ashworth scale (P<0.0001), decreasing area of CMAP (P=0.0055). Both groups demonstrated significant improvement in all measurements at four and eight weeks after injection. The high-volume group did not increase side effect, such as pain and weakness. A high volume preparation with a 5-fold dilution of BTX-A does yield better results than a low-volume preparation. A judicious use of BTX-A will result in fewer side effects and significant cost reduction. This study showed that the dilution volume has implication on the desired treatment effect of BTX-A.
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