Yun Ji Young, Kim Jae Woo, Kim Hee-Tae, Chung Sun Ju, Kim Jong-Min, Cho Jin Whan, Lee Jee-Young, Lee Ha Neul, You Sooyeoun, Oh Eungseok, Jeong Heejeong, Kim Young Eun, Kim Han-Joon, Lee Won Yong, Jeon Beom S
Department of Neurology, Ewha Womans University School of Medicine and Ewha Medical Research Institute, Seoul, Republic of Korea.
Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5.
We aimed to compare Dysport (abobotulinumtoxinA, Ipsen Biopharm, Slough, UK) and Botox (onabotulinumtoxinA, Allergan, Irvine, CA, USA) at a 2.5:1 ratio in the treatment of cervical dystonia (CD). A Dysport/Botox ratio of lower than 3:1 was suggested as a more appropriate conversion ratio, considering its higher efficacy and more frequent incidence of adverse effects not only in the treatment of CD but also in other focal movement disorders. A randomized, double-blind, multicenter, non-inferiority, two-period crossover study was done in CD, with a duration of at least 18 months. Patients were randomly assigned to treatment for the first period with Dysport or Botox, and they were followed up for 16 weeks after the injection. After a 4-week washout period, they were switched to the other formulation and then followed up for 16 weeks. The primary outcome was the changes in the Tsui scale between the baseline value and that at 1 month after each injection. A total of 103 patients were enrolled, and 94 completed the study. Mean changes in the Tsui scale between baseline and 4 weeks after each injection tended to favor Botox; however, this was not statistically significant (4.0 ± 3.9 points for the Dysport treatment vs. 4.8 ± 4.1 points for Botox; 95% confidence interval, -0.1-1.7; P = 0.091). The mean change of the Toronto western spasmodic torticollis rating scale score, the proportion of improvement in clinical global impression and patient global impression, and the incidences of adverse events were not significantly different between the two treatments. With regard to safety and efficacy, Dysport was not inferior to Botox in patients with CD at a conversion factor of 2.5:1. [clinicaltrial.gov: NCT00950664]
我们旨在以2.5:1的比例比较Dysport(阿柏西普肉毒杆菌毒素A,益普生生物制药公司,英国斯劳)和保妥适(A型肉毒杆菌毒素,艾尔建公司,美国加利福尼亚州欧文)治疗颈部肌张力障碍(CD)的效果。考虑到其不仅在治疗CD方面,而且在其他局灶性运动障碍方面具有更高的疗效和更频繁的不良反应发生率,建议低于3:1的Dysport/保妥适比例作为更合适的换算比例。在CD患者中进行了一项随机、双盲、多中心、非劣效性、两阶段交叉研究,持续时间至少18个月。患者在第一阶段被随机分配接受Dysport或保妥适治疗,并在注射后随访16周。经过4周的洗脱期后,他们换用另一种制剂,然后再随访16周。主要结局是每次注射后1个月时的Tsui量表相对于基线值的变化。总共招募了103名患者,94名完成了研究。每次注射后基线至4周时Tsui量表的平均变化倾向于保妥适;然而,这在统计学上并不显著(Dysport治疗组为4.0±3.9分,保妥适治疗组为4.8±4.1分;95%置信区间为-0.1至1.7;P = 0.091)。两种治疗之间,多伦多西部痉挛性斜颈评定量表评分的平均变化、临床总体印象改善比例和患者总体印象改善比例以及不良事件发生率均无显著差异。在安全性和有效性方面,在转换因子为2.5:1时,Dysport在CD患者中并不劣于保妥适。[临床试验注册号:NCT00950664]