Head of Movement Disorders Section, Department of Neurology, Hannover Medical School, Hannover, Germany.
Eur J Neurol. 2009 Dec;16 Suppl 2:2-5. doi: 10.1111/j.1468-1331.2009.02877.x.
Based upon large and carefully performed studies Xeomin was first registered in 2005. However, its real potential can only be assessed, when it is used outside of study design restrictions, in an independent setting, in off-label indications and during continued use.
Two hundred and sixty-three patients (91 with dystonia, 84 with spasticity, 17 with hemifacial spasm and re-innervation synkinesias, 64 with hyperhidrosis, 7 with hypersalivation), who were previously treated with Botox for at least 1 year under stable conditions, were converted in a blinded fashion to Xeomin using a 1:1 conversion ratio and identical treatment parameters. Therapeutic outcome and adverse effects were monitored by neurological examination and structuralised interviews. In 223 patients (all except those with axillary hyperhidrosis) Xeomin was used continuously throughout a 3 year period. Altogether 1050 injection series were performed. Patients with dystonia received 261.5 +/- 141.0 MU Botox/Xeomin, patients with spasticity 450.5 +/- 177.1 MU, patients with hemifacial spasm and reinnervation synkinesias 44.7 +/- 19.5 MU and patients with hyperhidrosis 286.9 +/- 141.6 MU. The maximum botulinum toxin dose applied was 840 MU. There were no subjective or objective differences between Botox and Xeomin treatments with respect to onset latency, maximum and duration of their therapeutic effects and their adverse effect profiles. Long-term use did not reveal additional safety relevant aspects. None of the patients lost therapeutic efficacy during the observation period.
Xeomin can be used safely in doses of up to 840 MU. Even when applied in high doses it did not produce secondary therapy failure. There were no diffusion differences between Botox and Xeomin. Using a conversion ratio of 1:1 Xeomin and Botox can easily be exchanged in a continued treatment.
基于大量精心设计的研究，Xeomin 于 2005 年首次注册。然而，只有在不受研究设计限制的情况下，在独立的环境中、用于未经批准的适应证以及持续使用时，才能真正评估其潜力。
263 例患者（91 例为肌张力障碍，84 例为痉挛，17 例为半面痉挛和再支配性联带运动，64 例为多汗症，7 例为流涎症），在稳定条件下至少接受了 1 年的 Botox 治疗，以 1:1 的转换率和相同的治疗参数转换为 Xeomin，进行了盲法治疗。通过神经学检查和结构化访谈监测治疗效果和不良反应。在 223 例患者（除腋窝多汗症患者外）中，Xeomin 在 3 年内持续使用。总共进行了 1050 次注射系列。肌张力障碍患者接受了 261.5 ± 141.0 MU Botox/Xeomin，痉挛患者接受了 450.5 ± 177.1 MU，半面痉挛和再支配性联带运动患者接受了 44.7 ± 19.5 MU，多汗症患者接受了 286.9 ± 141.6 MU。应用的最大肉毒毒素剂量为 840 MU。在起效潜伏期、治疗效果的最大和持续时间以及不良反应谱方面，Botox 和 Xeomin 治疗没有主观或客观差异。长期使用没有发现其他与安全性相关的方面。在观察期间，没有患者失去治疗效果。
Xeomin 可安全使用高达 840 MU 的剂量。即使在高剂量使用时，也不会导致继发性治疗失败。Botox 和 Xeomin 之间没有扩散差异。使用 1:1 的转换率，很容易在持续治疗中相互转换。
