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

Park, Shin-Hong; So, Yoon-Kyoung; Jeong, Han-Sin; Son, Young-Ik

J Korean Soc Laryngol Phoniatr Logop > Volume 18(1); 2007 > Article

Journal of The Korean Society of Laryngology, Phoniatrics and Logopedics 2007;18(1): 51-55.

연축성 발성장애 환자에서 냉동 보관한 보툴리늄 독소 주입술의 효과

박신홍, 소윤경, 정한신, 손영익

성균관대학교 의과대학 삼성서울병원 이비인후과학교실

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

Shin-Hong Park, Yoon-Kyoung So, Han-Sin Jeong, Young-Ik Son

Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine

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.

KEY WORDS： Spastic dysphonia;Botulium toxin type A;Drug storage;Freezing;