Department of Neurology, University of Rostock, Rostock, Germany.
Eur J Neurol. 2009 Dec;16 Suppl 2:6-10. doi: 10.1111/j.1468-1331.2009.02878.x.
Botulinum toxin type A (BoNT/A) is a highly effective and well-tolerated treatment for focal dystonias. The BoNT/A in Botox and Dysport is part of a high-molecular-weight complex that contains hemagglutinins and other non-toxic proteins, whilst Xeomin is a highly purified BoNT/A free of such complexing proteins. In the largest controlled study of BoNT/A published to date (Neurology 2005; 64: 1949), it was demonstrated that Xeomin is non-inferior to Botox and has 1:1 efficacy in the treatment of cervical dystonia. A possible limitation of continued BoNT/A treatment is antibody development. Based on its physiochemical properties and toxicological evidence, Xeomin is expected to have a reduced incidence of non-responders after long-term treatment compared with other marketed BoNT/A products.
In our ongoing open-label study, 100 patients suffering from cervical dystonia are continuously treated with Xeomin; 50 patients were treated de novo, the remaining patients had been previously treated with Botox, Dysport or NeuroBloc/Myobloc. All patients showed negative results in antibody testing at the beginning of Xeomin treatment. During continuous treatment with Xeomin up to 2 years, patients continued to respond well to Xeomin treatment.
The treatment was well tolerated and no patient has developed neutralizing antibodies as measured using the sensitive mouse hemidiaphragma assay within these first 2 years.
肉毒毒素 A 型（BoNT/A）是一种治疗局灶性肌张力障碍的高效且耐受性良好的药物。保妥适（Botox）和丽舒妥（Dysport）中的 BoNT/A 是一种高分子量复合物的一部分，其中包含血凝素和其他非毒性蛋白，而 Xeomin 则是一种不含此类结合蛋白的高度纯化 BoNT/A。在迄今为止发表的最大规模的 BoNT/A 对照研究中（神经病学 2005；64: 1949），证明 Xeomin 与 Botox 等效，且在治疗颈肌张力障碍方面具有 1:1 的疗效。持续 BoNT/A 治疗的一个可能局限性是抗体的产生。基于其理化性质和毒理学证据，预计 Xeomin 与其他已上市的 BoNT/A 产品相比，在长期治疗后非应答者的发生率更低。
在我们正在进行的开放标签研究中，100 例患有颈肌张力障碍的患者持续接受 Xeomin 治疗；其中 50 例为初次治疗，其余患者曾接受过 Botox、Dysport 或NeuroBloc/Myobloc 治疗。在开始 Xeomin 治疗时，所有患者的抗体检测结果均为阴性。在连续用 Xeomin 治疗长达 2 年期间，患者对 Xeomin 治疗的反应良好。
在这 2 年内，根据敏感的小鼠膈肌半膈试验，该治疗耐受性良好，没有患者产生中和抗体。
