Duarte Gonçalo S, Rodrigues Filipe B, Castelão Mafalda, Marques Raquel E, Ferreira Joaquim, Sampaio Cristina, Moore Austen P, Costa João
Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD004899. doi: 10.1002/14651858.CD004899.pub3.
This is an update of a Cochrane Review, first published in 2005. Hemifacial spasm (HFS) is characterised by unilateral, involuntary contractions of the muscles innervated by the facial nerve. It is a chronic disorder, and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and intramuscular injections with botulinum toxin type A (BtA).
To compare the efficacy, safety, and tolerability of BtA versus placebo in people with HFS.
We searched CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. We ran the electronic database search, with no language restrictions, in July 2020.
Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with HFS.
Two review authors independently assessed records. We planned to select included studies, extract data using a paper pro forma, and evaluate the risk of bias. We resolved disagreements by consensus, or by consulting a third review author. We planned to perform meta-analyses. The primary efficacy outcome was HFS-specific improvement. The primary safety outcome was the proportion of participants with any adverse event.
We found no parallel-group randomised controlled trials comparing BtA and placebo in HFS.
AUTHORS' CONCLUSIONS: We did not find any randomised trials that evaluated the efficacy and safety of botulinum toxin type A in people with hemifacial spasm, so we are unable to draw any conclusions. Observational data show a strong association between BtA treatment and symptom improvement, and a favourable safety profile. While it is unlikely that future placebo-controlled RCTs will evaluate absolute efficacy and safety, they should address relevant questions for both people with HFS (such as long-term effects, quality of life, and other patient-reported outcomes), and clinicians (such as relative effectiveness of different BtA formulations and schemes of treatment) to better guide clinical practice.).
这是一篇Cochrane系统评价的更新，首次发表于2005年。面肌痉挛（HFS）的特征是由面神经支配的肌肉出现单侧、不自主收缩。它是一种慢性疾病，自发恢复非常罕见。两种常规可用的治疗方法是微血管减压术和A型肉毒杆菌毒素（BtA）肌肉注射。
比较BtA与安慰剂治疗HFS患者的疗效、安全性和耐受性。
我们于2020年7月检索了Cochrane系统评价数据库、MEDLINE、Embase、文章参考文献列表和会议论文集。我们于2020年7月进行电子数据库检索，无语言限制。
关于BtA与安慰剂对比治疗成人HFS的双盲、平行、随机、安慰剂对照试验（RCT）。
两位综述作者独立评估记录。我们计划选择纳入研究，使用纸质表格提取数据，并评估偏倚风险。我们通过协商一致或咨询第三位综述作者来解决分歧。我们计划进行Meta分析。主要疗效结局是HFS特异性改善。主要安全性结局是发生任何不良事件的参与者比例。
我们未找到比较BtA与安慰剂治疗HFS的平行组随机对照试验。
我们未找到任何评估A型肉毒杆菌毒素治疗面肌痉挛患者疗效和安全性的随机试验，因此无法得出任何结论。观察性数据显示BtA治疗与症状改善之间有很强的关联，且安全性良好。虽然未来不太可能有安慰剂对照的RCT来评估绝对疗效和安全性，但它们应解决HFS患者（如长期影响、生活质量和其他患者报告结局）以及临床医生（如不同BtA制剂的相对有效性和治疗方案）的相关问题，以更好地指导临床实践。
