Efficacy of Frozen Reconstituted Botulinum Toxin Type A for the Treatment of Spasmodic Dysphonia

연축성 발성장애 환자에서 냉동 보관한 보툴리늄 독소 주입술의 효과

  • Park, Shin-Hong (Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • So, Yoon-Kyoung (Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Jeong, Han-Sin (Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Son, Young-Ik (Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • 박신홍 (성균관대학교 의과대학 삼성서울병원 이비인후과학교실) ;
  • 소윤경 (성균관대학교 의과대학 삼성서울병원 이비인후과학교실) ;
  • 정한신 (성균관대학교 의과대학 삼성서울병원 이비인후과학교실) ;
  • 손영익 (성균관대학교 의과대학 삼성서울병원 이비인후과학교실)
  • Published : 2007.06.15

Abstract

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 $-25^{\circ}C$ 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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