Wohlfarth Kai, Müller Christian, Sassin Irena, Comes Georg, Grafe Susanne
Humaine Klinikum Bad Saarow, Germany.
Clin Neuropharmacol. 2007 Mar-Apr;30(2):86-94. doi: 10.1097/01.WNF.0000240951.18821.50.
Safety and efficacy of botulinum neurotoxin type A preparation NT 201 (Xeomin, Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) were investigated over 52 weeks in a double-blind, randomized trial with 32 male volunteers.
Electroneurographic assessments with surface electrodes were performed after single injections of NT 201 (2, 4, 16, or 32 units) into the extensor digitorum brevis (EDB) muscle and the same dose (Botox; Allergan Pharmaceuticals (Ireland) Ltd. Westport, Ireland) into the contralateral EDB.
All NT 201 and BTXCo doses achieved a statistically significant reduction of the compound muscle action potential M-wave amplitude in the EDB muscle. At week 4, the highest dose was statistically significantly more effective than the lowest dose (NT 201, P = 0.019; 95% confidence interval, 0.195-1.370; and BTXCo, P = 0.002; 95% confidence interval, 0.309-1.167). Duration of effect was dose dependent. The mean values of compound muscle action potential M-wave amplitudes in the adjacent muscles (abductor digiti quinti and abductor hallucis) were above the predefined threshold of effect, indicating that there was no relevant diffusion-induced reduction of muscle activity. NT 201 and BTXCo were well tolerated.
NT 201 is effective and safe in inducing the desired paretic effect.
在一项针对32名男性志愿者的双盲、随机试验中，对A型肉毒杆菌神经毒素制剂NT 201（Xeomin，德国美兹制药有限公司，美因河畔法兰克福）进行了为期52周的安全性和有效性研究。
将NT 201（2、4、16或32单位）单次注射到趾短伸肌（EDB）中，并将相同剂量（保妥适；爱尔兰艾尔建制药有限公司，韦斯特波特）注射到对侧EDB中，之后用表面电极进行神经电图评估。
所有NT 201和保妥适剂量均使EDB肌肉中的复合肌肉动作电位M波幅出现统计学上的显著降低。在第4周时，最高剂量在统计学上比最低剂量更有效（NT 201，P = 0.019；95%置信区间，0.195 - 1.370；保妥适，P = 0.002；95%置信区间，0.309 - 1.167）。作用持续时间呈剂量依赖性。相邻肌肉（小指展肌和拇展肌）中复合肌肉动作电位M波幅的平均值高于预先定义的效应阈值，表明不存在因扩散引起的相关肌肉活动降低。NT 201和保妥适耐受性良好。
NT 201在诱导所需的麻痹效果方面有效且安全。
