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首页> 外文期刊>Journal of neural transmission >Double-blind, randomised, parallel group pilot study comparing two botulinum toxin type A products for the treatment of blepharospasm.
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Double-blind, randomised, parallel group pilot study comparing two botulinum toxin type A products for the treatment of blepharospasm.

机译：一项双盲，随机，平行分组的先导研究，比较了两种A型肉毒杆菌毒素产品治疗眼睑痉挛的方法。

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摘要

Botulinum neurotoxins (BoNTs) are the primary treatment for focal dystonias such as blepharospasm. Several different BoNT products are available in various countries. Given the variability in manufacturing, formulation, and unit doses of BoNTs, it is important to compare the profiles of products from different manufacturers. This double-blind, randomised, parallel-group pilot study compared the efficacy and safety of the BoNT type A product Xeomin(R) from Merz to BOTOX(R) from Allergan. Subjects (n = 65) were randomly assigned to receive one or the other BoNTA in a 1:1 proportion at a dose equal to that of their most recent treatment (>/=20 U/eye). Symptoms were assessed on the Blepharospasm Disability Index (BSDI), Jankovic Rating Scale (JRS), and Patient Global Assessment (PGA) scale at 4 and 8 weeks. Both BoNTA products reduced scores on the BSDI and JRS (no statistically significant difference, tendency toward greater improvements with BOTOX(R) than Xeomin(R) at 4 and 8 weeks). A post hoc analysis showed a significantly greater number of BOTOX(R) treated patients reaching a responder threshold of 4 points on the total BSDI score and 0.67 points on the BSDI mean item score. No significant differences between products were noted in PGA and adverse events at the doses used in this study.
机译：肉毒杆菌神经毒素（BoNTs）是局灶性肌张力障碍（例如眼睑痉挛）的主要治疗方法。各个国家/地区提供几种不同的BoNT产品。鉴于BoNT生产，配方和单位剂量的可变性，重要的是比较不同制造商的产品概况。这项双盲，随机，平行分组的先导研究比较了Merz的BoNT A型产品和Allergan的BOTOX的功效和安全性。随机分配受试者（n = 65）以1：1的比例接受一个或另一个BoNTA，剂量等于他们最近的治疗剂量（> / = 20 U /眼）。在第4周和第8周，根据眼睑痉挛残疾指数（BSDI），扬科维奇评定量表（JRS）和患者总体评估（PGA）量表评估症状。两种BoNTA产品都降低了BSDI和JRS的评分（在统计上没有显着差异，在第4周和第8周，BOTOX®比Xeomin®有更大的改善趋势）。事后分析表明，接受BOTOX（R）治疗的患者数量显着增加，达到总BSDI得分4分和BSDI平均项目得分0.67分的反应者阈值。在本研究中使用的剂量，在PGA和不良事件之间未发现产品之间的显着差异。

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