期刊名称：Journal of the Korean Ophthalmological Society
印刷版ISSN：0378-6471
出版年度：2020
卷号：61
期号：3
页码：227-234
DOI：10.3341/jkos.2020.61.3.227
出版社：The Korean Ophthalmological Society
摘要：Purpose To evaluate the efficacy and safety of BOTULAX® in subjects with essential blepharospasm. Methods In this study, a total of 250 subjects with essential blepharospasm were enrolled at 15 investigational sites and a total of 220 subjects completed the study. The efficacy and safety were evaluated at weeks 4 and 16 after treatment compared with baseline. In total, 240 subjects were enrolled, treated with the investigational product, and evaluable for the primary efficacy assessment at week 4 after treatment; these subjects were included in the intention-to-treat (ITT) population. With the ITT set as the main efficacy set, efficacy assessment included Jankovic rating scale (JRS), functional disability score, investigator evaluation of global response and quality of life. Safety assessment including the incidence of adverse events was also performed. Results In terms of the primary efficacy endpoint (i.e., change in JRS total score at week 4 after treatment from baseline [ITT set]), mean change indicated a statistically significant reduction ( p < 0.0001) and demonstrated the non-inferiority of the test drug to similar drugs. In terms of the secondary efficacy endpoints, mean change in JRS total score at week 16 after treatment and mean change in functional disability score at weeks 4 and 16 after treatment both exhibited a statistically significant reduction compared with baseline ( p < 0.0001 for all). Among the 249 subjects treated with the investigational product in this study, 44 (17.67%) experienced 76 treatment emergent adverse events but no serious adverse events were observed. Conclusions Based on the study results, BOTULAX® is considered to be an effective and safe treatment for essential blepharospasm..
关键词：BOTULAX®; Botulinum neurotoxin type A; Essential blepharospasm; Letibotulinum Toxin A
