Ranoux D, Gury C, Fondarai J, Mas J L, Zuber M
Service de Neurologie, Hôf.pital Sainte-Anne, Paris, France.
J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):459-62. doi: 10.1136/jnnp.72.4.459.
Botulinum toxin type A is a potent neuromuscular paralyzing agent used in various disorders including cervical dystonia. Two preparations of botulinum toxin are now commercially available ( Dysport and Botox), but much controversy remains about their respective potencies. The aim of the study was to compare the efficacy of Botox with two different ratios of Dysport.
A double blind, randomised, three period cross over study involving 54 patients with cervical dystonia was performed. The patients received the following treatments in a randomised order: Botox at the usually effective dose, Dysport at a dose of 1:3 (conversion factor of 3 between Botox and Dysport units-that is, one Botox unit=three Dysport units) and at a dose of 1:4 (conversion factor of four). The improvement of the Tsui (primary outcome criteria) and of the TWSTRS pain scales between baseline and a control visit 1 month after each of the three injections, as well as the incidence of adverse events, were assessed.
Comparison of the Tsui scores and of the TWSTRS pain scores showed a better effect on impairment and pain with Dysport 1:3 (p=0.02 and 0.04, respectively) and 1:4 (p=0.01 and 0.02, respectively) than with Botox. The number of adverse events was higher with both Dysport treatments. The most frequent adverse event was dysphagia, found in 3%, 15.6%, and 17.3% (Botox, Dysport 1:3 and 1:4, respectively) of the patients. No adverse event required withdrawal of therapy or specific management.
Dysport 1:3 (and Dysport 1:4 to a greater extent) is more efficient than Botox for both impairment and pain in cervical dystonia although with a somewhat higher incidence of minor adverse effects. This strongly suggests that the most appropriate conversion factor between Botox and Dysport units is less than 3 in cervical dystonia.
A型肉毒毒素是一种强效的神经肌肉麻痹剂，用于包括颈部肌张力障碍在内的多种疾病。目前有两种肉毒毒素制剂在市场上销售（Dysport和保妥适），但关于它们各自的效力仍存在很多争议。本研究的目的是比较保妥适与两种不同比例Dysport的疗效。
对54例颈部肌张力障碍患者进行了一项双盲、随机、三阶段交叉研究。患者按随机顺序接受以下治疗：通常有效剂量的保妥适、1:3剂量的Dysport（保妥适单位与Dysport单位之间的换算系数为3，即1个保妥适单位 = 3个Dysport单位）和1:4剂量的Dysport（换算系数为4）。评估了三次注射后每次注射后1个月的基线与对照访视之间的徐氏评分（主要结局标准）和TWSTRS疼痛量表的改善情况，以及不良事件的发生率。
徐氏评分和TWSTRS疼痛评分的比较显示，1:3（分别为p = 0.02和0.04）和1:4（分别为p = 0.01和0.02）的Dysport对损伤和疼痛的效果优于保妥适。两种Dysport治疗的不良事件数量均较高。最常见的不良事件是吞咽困难，分别在3%、15.6%和17.3%的患者中出现（保妥适、1:3的Dysport和1:4的Dysport）。没有不良事件需要停止治疗或进行特殊处理。
对于颈部肌张力障碍的损伤和疼痛，1:3的Dysport（以及在更大程度上1:4的Dysport）比保妥适更有效，尽管轻微不良反应的发生率略高。这强烈表明，在颈部肌张力障碍中，保妥适单位与Dysport单位之间最合适的换算系数小于3。
