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KMID : 0384020070180010051
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Journal of the Korean Society of Logopedics and Phoniatrics
2007 Volume.18 No. 1 p.51 ~ p.55
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Efficacy of Fozen Reconstituted Botulinum Toxin Type A for the Treatment of Spasmodic Dysphonia
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Park Shin-Hong
So Yoon-Kyoung
Jeong Han-Sin
Son Young-Ik
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Abstract
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Objectives: The aim of this study is to compare the efficacy of fresh versus frozen reconstituted botulinum toxin type A (BTX-A) for the treatment of adductor type spasmodic dysphonia.
Materials and Methods: After reconstitution with normal saline, BTX-A was used within 4 hours or it was kept frozen in a consumer grade freezer at about -25?C for up to 4 months. Thirty patients with spasmodic dysphonia were randomly assigned and treated with the either fresh or frozen BTX-A. About 83% of injections resulted in a satisfactory outcome with 5.3 months of mean action duration. Treatment outcomes and side effects of total 161 injections were compared along the duration of keeping BTX-A frozen.
Results: There were no statistical differences in the duration of action, self-rated satisfaction score, and the duration of hoarseness and/or aspiration between fresh and frozen BTX-A treated groups. No significant side effects were observed and the frozen BTX-A were proved to be free of bacterial contamination.
Conclusion: After being reconstituted and kept frozen, BTX-A may be safely used for more than 4 months without significant loss of its effectiveness or additional side effects.
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KEYWORD
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Spastic dysphonia, Botulium toxin type A, Drug storage, Freezing
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