Purpose

To review the medical literature on the outcomes and complications of various Food and Drug Administration-approved botulinum toxins for benign essential blepharospasm (BEB) and hemifacial spasm (HFS).

Methods

Literature searches were last conducted in February 2017 in PubMed for articles published in English and in the Cochrane Library database without language limitations; studies published before 2000 were excluded. The combined searches yielded 127 citations. Of these, 13 articles were deemed appropriate for inclusion in this assessment, and the panel methodologist assigned ratings to them according to the level of evidence.

Results

A combined total of 1523 patients (1143 with BEB and 380 with HFS) were included in the 13 studies. Five studies provided level I evidence, 2 studies provided level II evidence, and 6 studies provided level III evidence. Pretarsal injections were more efficacious than preseptal injections (96% vs. 86%, respectively). Pretarsal injections also resulted in a higher response rate on clinical scales (P < 0.05) and a longer duration of maximum response for both HFS and BEB. Patients with HFS require lower overall doses of onabotulinumtoxinA than patients with BEB for a similar duration of effect. Adverse events were dose related, and they occurred more frequently in patients who were given more units.

Conclusions

Level I evidence supports the efficacy of Botox (Allergan Corp., Irvine, CA), Meditoxin, and Xeomin (Merz Pharmaceuticals, Frankfurt am Main, Germany) for the treatment of BEB. Meditoxin and Botox have equivalent effectiveness and incidence of adverse events for BEB and HFS. Dysport (Ipsen Biopharmaceuticals, Inc, Paris, France) seems to have efficacy similar to Botox and Meditoxin for BEB and HFS, but any definitive conclusions from the 2 level II studies in this review are limited by differences in the methodologies used. Higher doses of Botox and Dysport result in more adverse events. Repeated treatments using Botox seem to maintain efficacy for treatment of facial dystonias over a follow-up period of at least 10 years, based on level III evidence.

中文翻译：

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化学治疗神经性面肌张力障碍

目的

审查有关良性原发性眼睑痉挛（BEB）和面肌痉挛（HFS）的各种食品和药物管理局批准的肉毒杆菌毒素的疗效和并发症的医学文献。

方法

文献检索最后一次于2017年2月在PubMed中进行了英语检索和Cochrane图书馆数据库中无语言限制的文章检索; 2000年之前发表的研究被排除在外。合并搜索得出127次引用。在这些评估中，有13篇文章被认为适合纳入本评估，专家组方法学家根据证据水平对它们进行了评级。

结果

13项研究共纳入1523例患者（1143例BEB和380例HFS）。五项研究提供了I级证据，2项研究提供了II级证据，6项研究提供了III级证据。tar前注射比隔前注射更有效（分别为96％和86％）。tar前注射在临床上也导致较高的缓解率（P <0.05），并且对于HFS和BEB的最大缓解持续时间更长。对于HFS患者，在相似的作用持续时间内，其总剂量的肉毒杆菌毒素A低于BEB患者。不良事件与剂量有关，在给予更多单位的患者中更经常发生。

结论

I级证据支持肉毒杆菌毒素（美国加利福尼亚州尔湾市的Allergan公司），Meditoxin和Xeomin（德国美因河畔法兰克福的梅尔药业）的功效。Meditoxin和Botox对BEB和HFS具有同等效力和不良事件发生率。Dysport（Ipsen Biopharmaceuticals，Inc，法国巴黎）似乎具有与肉毒杆菌毒素和Meditoxin相似的BEB和HFS功效，但本评价中的2个II级研究的任何明确结论均受所用方法学差异的限制。较高剂量的肉毒杆菌毒素和运动不良会导致更多的不良事件。根据III级证据，使用肉毒杆菌毒素进行的重复治疗似乎可以在至少10年的随访期内保持治疗面部肌张力障碍的功效。