Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany,
J Neural Transm (Vienna). 2014 Jan;121(1):29-31. doi: 10.1007/s00702-013-1076-z. Epub 2013 Aug 4.
Several botulinum toxin (BT) drugs are licensed for the treatment of cervical dystonia (CD). We wanted to compare the efficacy and the potency labelling of incobotulinumtoxinA (Xeomin(®)) and onabotulinumtoxinA (Botox(®)) by analysing the duration of their therapeutic effect in a cross-over study. For this we studied 40 CD patients (26 females, 14 males, age at therapy onset 52.6 ± 12.0 years, duration of dystonia at therapy onset 10.0 ± 9.2 years, Tsui score 9.1 ± 3.9) who first received Botox(®) and then Xeomin(®) for at least 4 injection series each. BT doses were exchanged based on a 1:1 conversion ratio. Altogether 1,101 treatment cycles were evaluated. For each patient 27.5 ± 13.1 treatment cycles were recorded. Patients received 18.4 ± 12.4 treatment cycles with Botox(®) and 9.2 ± 4.5 with Xeomin(®). The treatment duration (TD) throughout the treatment course was 11.3 ± 1.0 weeks (Botox(®) 11.2 ± 1.1 weeks, Xeomin(®) 11.4 ± 1.3 weeks). The interinjection interval (II) throughout the treatment course was 14.8 ± 1.9 weeks (Botox(®) 14.7 ± 1.6 weeks, Xeomin(®) 15.0 ± 2.2 weeks). The mean difference between Botox(®) and Xeomin(®) was 0.3 weeks for TD (two-sided 95 % confidence interval [-0.3; 0.9]) and 0.5 weeks for II (two-sided 95 % confidence intervals [-0.4; 1.4]). The confidence intervals of both parameters were within the predefined therapeutic equivalence range set to ±1.5 weeks, thus indicating similar efficacy of both BT drugs. Having based the exchange of Botox(®) and Xeomin(®) on a conversion factor of 1:1 our data confirm previous findings of an identical potency labelling of both products, thus allowing comparisons of efficacy, adverse effects and costs.
几种肉毒毒素（BT）药物已获得许可用于治疗颈部肌张力障碍（CD）。我们希望通过交叉研究分析其治疗效果的持续时间来比较 IncobotulinumtoxinA（Xeomin®）和 OnabotulinumtoxinA（Botox®）的疗效和效价标记。为此，我们研究了 40 名 CD 患者（26 名女性，14 名男性；治疗开始时的年龄为 52.6±12.0 岁；治疗开始时的肌张力障碍持续时间为 10.0±9.2 年；Tsui 评分为 9.1±3.9），他们首先接受 Botox®治疗，然后至少接受了 4 个系列的 Xeomin®治疗。根据 1:1 的转换比交换 BT 剂量。总共评估了 1101 个治疗周期。每个患者记录了 27.5±13.1 个治疗周期。患者接受了 18.4±12.4 个 Botox®治疗周期和 9.2±4.5 个 Xeomin®治疗周期。整个治疗过程中的治疗持续时间（TD）为 11.3±1.0 周（Botox®11.2±1.1 周，Xeomin®11.4±1.3 周）。整个治疗过程中的注射间隔（II）为 14.8±1.9 周（Botox®14.7±1.6 周，Xeomin®15.0±2.2 周）。Botox®和 Xeomin®之间的平均差异为 0.3 周，TD（双侧 95%置信区间[-0.3；0.9]）和 0.5 周，II（双侧 95%置信区间[-0.4；1.4]）。这两个参数的置信区间都在预设的治疗等效范围内，设定为±1.5 周，因此表明两种 BT 药物的疗效相似。根据 1:1 的转换因子交换 Botox®和 Xeomin®，我们的数据证实了先前发现的两种产品具有相同的效价标记，从而允许比较疗效、不良反应和成本。
