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Dose standardization of botulinum toxin.肉毒杆菌毒素的剂量标准化
Mov Disord. 1998 Jul;13(4):749-51. doi: 10.1002/mds.870130425.
2
What is the optimal dose of botulinum toxin A in the treatment of cervical dystonia? Results of a double blind, placebo controlled, dose ranging study using Dysport. German Dystonia Study Group.治疗颈部肌张力障碍时A型肉毒杆菌毒素的最佳剂量是多少?使用Dysport进行的双盲、安慰剂对照、剂量范围研究结果。德国肌张力障碍研究小组。
J Neurol Neurosurg Psychiatry. 1998 Jan;64(1):13-7. doi: 10.1136/jnnp.64.1.13.
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A double blind, randomised, parallel group study to investigate the dose equivalence of Dysport and Botox in the treatment of cervical dystonia.一项双盲、随机、平行组研究,旨在调查Dysport和保妥适在治疗颈部肌张力障碍方面的剂量等效性。
J Neurol Neurosurg Psychiatry. 1998 Jan;64(1):6-12. doi: 10.1136/jnnp.64.1.6.
4
DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.DYSBOT:一项单盲、随机平行研究,旨在确定在A型肉毒杆菌毒素的两种制剂(Dysport和保妥适)的疗效和耐受性方面是否能检测到差异,假设比例为4:1。
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Naunyn Schmiedebergs Arch Pharmacol. 1997 Mar;355(3):335-40. doi: 10.1007/pl00004951.
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Comparison of clinical rating scales in treatment of cervical dystonia with botulinum toxin.肉毒杆菌毒素治疗颈部肌张力障碍中临床评定量表的比较
Mov Disord. 1997 Jan;12(1):100-2. doi: 10.1002/mds.870120117.
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The variability in the clinical effect induced by botulinum toxin type A: the role of muscle activity in humans.A型肉毒杆菌毒素所致临床效应的变异性:肌肉活动在人体中的作用。
Mov Disord. 1997 Jan;12(1):89-94. doi: 10.1002/mds.870120115.
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Botulinum toxin: dangerous terminology errors.肉毒杆菌毒素:危险的术语错误。
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Therapeutic botulinum toxin.治疗性肉毒杆菌毒素。
Lancet. 1994 Nov 12;344(8933):1370. doi: 10.1016/s0140-6736(94)90732-3.
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Dose standardisation of botulinum toxin.肉毒杆菌毒素的剂量标准化
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保妥适(Botox)与吉适(Dysport)的相对效力:一项关于颈部肌张力障碍的双盲、随机、交叉研究

Respective potencies of Botox and Dysport: a double blind, randomised, crossover study in cervical dystonia.

作者信息

Ranoux D, Gury C, Fondarai J, Mas J L, Zuber M

机构信息

Service de Neurologie, Hôf.pital Sainte-Anne, Paris, France.

出版信息

J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):459-62. doi: 10.1136/jnnp.72.4.459.

DOI:10.1136/jnnp.72.4.459
PMID:11909903
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1737843/
Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

方法

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。

结果

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。

结论

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。