Quantitative assessment of efficacy of dysport (botulinum toxin type A) in the treatment of idiopathic blepharospasm and hemifacial spasm.
This study was a Phase IV, prospective, one arm, non-comparative open trial, to investigate the efficacy and safety of Dysport (Botulinum toxin type A) in patients with idiopathic blepharospasm or hemifacial spasm. During the treatment period, patients were evaluated at baseline (week 0), week 6, and week 8, 10, or 12. Thirty two women and 16 men completed the whole course of the study. The therapeutic efficacy of Dysport became evident from 1.5 to 15 days (mean+/- SD, 6.1 +/- 2.9 days). The maximal effect appeared 12.2+/-5.0 days later. Injection of Dysport achieved 72.9 (13.0% amelioration in the spasm symptom. Dysport significantly improved the following functions, such as reading, watching TV, house work, working, driving and outing alone. At the twelfth week after Dysport injection, it was still effective in relieving blepharospasm or hemifacial spasm. The most frequent adverse event was ptosis, which was noted in 9 cases and represented 18.7% of total patients. Other adverse events were very mild, although lagophthalmos and dry eyes occurred in some patients, but none manifested any corneal complications. In conclusion, Dysport injection appears to be a safe, and effective procedure - accompanied only by minor, and transit adverse events.
Tsai
Ching-Piao
CP
Neurology, The Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan. cptsai@vghtpe.gov.tw
Chiu
Ming-Chang
MC
Yen
Der-Jen
DJ
Guo
Yuh-Cherng
YC
Yuan
Chih-Lun
CL
Lee
Tzu-Chi
TC
D000328:Adult; D000368:Aged; D001764:Blepharospasm / Q000188:drug therapy*; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D019569:Hemifacial Spasm / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors
D019274:Botulinum Toxins, Type A