Naumann M, Yakovleff A, Durif F
Neurologische Universitatsklinik, Würzburg, Germany.
J Neurol. 2002 Jan;249(1):57-63. doi: 10.1007/pl00007848.
In 1997, the US FDA approved a new bulk toxin source (now referred to as current) for the manufacture of botulinum toxin type A (BTX-A). The current BTX-A preparation has a lower neurotoxin complex protein load than the original BTX-A preparation, which may reduce antigenic potential. The present double-masked, multicenter study compared the efficacy and safety of BTX-A (BOTOX) produced from both original and current bulk toxin sources for the treatment of cervical dystonia. Patients (N = 133) were injected with BTX-A produced from original and current bulk toxin sources using a crossover design. Adverse events were assessed at each visit. Efficacy was assessed at 2 and 6 weeks post-injection using the severity and pain-disability subscales of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). Mean BTX-A doses were comparable (original: 155 U, current: 156 U). Both BTX-A preparations produced similar, statistically significant reductions in TWSTRS severity and pain-disability scores at weeks 2 and 6 post-injection. The original and current BTX-A preparations showed no significant differences in adverse events, including both treatment-related (34%, 31%) and treatment-unrelated (27%, 32%), respectively. BTX-A produced from the original and current bulk toxin sources showed comparable efficacy and safety in the treatment of cervical dystonia; both significantly reduced dystonia severity and pain.
1997年，美国食品药品监督管理局（US FDA）批准了一种用于制造A型肉毒杆菌毒素（BTX-A）的新的大宗毒素来源（现称为现行来源）。现行的BTX-A制剂的神经毒素复合蛋白含量低于原始的BTX-A制剂，这可能会降低抗原性。本双盲、多中心研究比较了由原始和现行大宗毒素来源生产的BTX-A（保妥适）治疗颈部肌张力障碍的疗效和安全性。患者（N = 133）采用交叉设计接受了分别由原始和现行大宗毒素来源生产的BTX-A注射。每次就诊时评估不良事件。在注射后2周和6周，使用多伦多西部痉挛性斜颈评定量表（TWSTRS）的严重程度和疼痛-功能障碍子量表评估疗效。平均BTX-A剂量相当（原始来源：155 U，现行来源：156 U）。两种BTX-A制剂在注射后第2周和第6周均使TWSTRS严重程度和疼痛-功能障碍评分产生了相似的、具有统计学意义的降低。原始和现行的BTX-A制剂在不良事件方面无显著差异，包括与治疗相关的不良事件（分别为34%、31%）和与治疗无关的不良事件（分别为27%、32%）。由原始和现行大宗毒素来源生产的BTX-A在治疗颈部肌张力障碍方面显示出相当的疗效和安全性；两者均显著降低了肌张力障碍的严重程度和疼痛。
