Odergren T, Hjaltason H, Kaakkola S, Solders G, Hanko J, Fehling C, Marttila R J, Lundh H, Gedin S, Westergren I, Richardson A, Dott C, Cohen H
Department of Neurology, Karolinska Hospital, Stockholm, Sweden.
J Neurol Neurosurg Psychiatry. 1998 Jan;64(1):6-12. doi: 10.1136/jnnp.64.1.6.
This study was designed to establish whether a ratio of three units of Dysport is equivalent to one unit of Botox for the treatment of cervical dystonia.
Patients with predominantly rotational cervical dystonia, and a minimum of four previous Botox treatments, were randomised to receive either the clinically indicated dose of Botox or three times that dose in Dysport units. Study botulinum toxin was administered in a double blind fashion, to one or more clinically indicated muscles, at one or more sites per muscle. Patients returned for assessment two, four, eight, and 12 weeks after treatment.
A total of 73 patients (Dysport, 38; Botox, 35) were entered. The Dysport group received a mean (SD) dose of 477 (131) (range 240-720) Dysport units, and the Botox group received a mean (SD) dose of 152 (45) (range 70-240) Botox units. The mean (SEM) post-treatment Tsui scores for the Dysport group (4.8 (0.3)) and the Botox group (5.0 (0.3)) were not statistically different (p=0.66). The study had 91% power to detect a clinically significant difference of two points. Both groups showed substantial improvement in Tsui score by week 2 (mean (SD); Dysport, 46 (28)%; Botox, 37 (28)%), with a peak effect at week 4 (mean (SD); Dysport, 49 (29)%; Botox, 44 (28)%). A similar response profile was seen for other assessments of efficacy. The duration of effect, assessed by time to retreatment, was also similar (mean (SD); Dysport, 83.9 (13.6) days; Botox, 80.7 (14.4) days; p=0.85). During the study 22 of 38 (58%) Dysport patients reported 39 adverse events, and 24 of 35 (69%) Botox patients reported 56 adverse events (p=0.35). A global assessment of efficacy and safety considered that 29 of 38 (76%) Dysport patients and 23 of 35 (66%) Botox patients were treatment successes (p=0.32).
Patients with predominantly rotational cervical dystonia treated with the clinically indicated dose of Botox or three times that dose in Dysport units show similar improvements and do not have significantly different safety profiles.
本研究旨在确定3个单位的Dysport与1个单位的保妥适在治疗颈部肌张力障碍方面是否等效。
以旋转性颈部肌张力障碍为主且此前至少接受过4次保妥适治疗的患者被随机分为两组，分别接受临床指示剂量的保妥适或3倍该剂量的Dysport单位治疗。研究用肉毒毒素以双盲方式注射到一个或多个临床指示的肌肉，每个肌肉注射一个或多个部位。患者在治疗后2周、4周、8周和12周返回进行评估。
共纳入73例患者（Dysport组38例；保妥适组35例）。Dysport组平均（标准差）剂量为477（131）（范围240 - 720）个Dysport单位，保妥适组平均（标准差）剂量为152（45）（范围70 - 240）个保妥适单位。Dysport组（4.8（0.3））和保妥适组（5.0（0.3））治疗后的平均（标准误）徐氏评分无统计学差异（p = 0.66）。该研究有91%的把握度检测出临床显著差异达2分。两组在第2周时徐氏评分均有显著改善（平均（标准差）；Dysport组，46（28）%；保妥适组，37（28）%），在第4周达到峰值效应（平均（标准差）；Dysport组，49（29）%；保妥适组，44（28）%）。其他疗效评估也呈现相似的反应曲线。通过再次治疗时间评估的疗效持续时间也相似（平均（标准差）；Dysport组，83.9（13.6）天；保妥适组，80.7（14.4）天；p = 0.85）。研究期间，38例Dysport患者中有22例（58%）报告了39起不良事件，35例保妥适患者中有24例（69%）报告了56起不良事件（p = 0.35）。对疗效和安全性的整体评估认为，38例Dysport患者中有29例（76%）、35例保妥适患者中有23例（66%）治疗成功（p = 0.32）。
以旋转性颈部肌张力障碍为主的患者，接受临床指示剂量的保妥适或3倍该剂量的Dysport单位治疗，改善情况相似，安全性方面无显著差异。
