Frampton James E, Easthope Stephanie E
Adis International Inc, Yardley, Pennsylvania 19047, USA.
Am J Clin Dermatol. 2003;4(10):709-25. doi: 10.2165/00128071-200304100-00005.
Botox Cosmetic (Botox) is a formulation of the neuromuscular blocking agent botulinum toxin type A (BTX-A). When injected into hyperactive corrugator superciliaris and/or procerus muscles of the face that predominantly control frowning, Botox produces a transient (3- to 6-month), dose-dependent localized muscle weakness, resulting in a temporary improvement in glabellar frown lines ('brow furrows'). After a decade of successful 'off-label' use, the efficacy and tolerability of Botox (total dose 20 biological units) in the treatment of glabellar frown lines have been demonstrated in two identical, large, multicenter, randomized, double-blind, placebo-controlled pivotal trials in a total of 537 subjects, mostly women, with moderate or severe glabellar lines during facial animation. Based both on subjects' and physicians' assessments, the improvement in glabellar lines with Botox was superior to that with placebo at each visit during the 120-day post-injection follow-up period, beginning on day 7 post-injection. The peak effect was seen on day 30 post-injection when 80% of subjects in the two studies combined had the severity of their lines at maximum frown reduced to mild or none, as assessed by their physician, and 89% had at least a moderate (> or =50%) improvement in the appearance of their glabellar lines, as rated by themselves. In a noncomparative extension of these trials, there was a tendency for a higher proportion of subjects to respond to Botox injections after a second and third treatment session. Botox injections for glabellar lines are well tolerated. Headache, the most common adverse event, occurred with a similar frequency to placebo in the two pivotal studies (13% vs 18%). Temporary blepharoptosis occurred in 3.2% of Botox recipients; however, the incidence of this adverse event tended to decrease with repeated treatment sessions. In summary, Botox injections offer a convenient, effective, and well tolerated treatment for improving glabellar frown lines. Repeated injections are necessary to maintain a long-term effect; however, this technique clearly represents an attractive option for individuals who wish to avoid a more major procedure.
保妥适美容针剂（Botox）是一种A型肉毒杆菌毒素（BTX - A）的神经肌肉阻滞剂制剂。当注射到主要控制皱眉的面部皱眉肌和/或降眉间肌过度活跃的部位时，保妥适会产生短暂的（3至6个月）、剂量依赖性的局部肌肉无力，从而使眉间皱纹（“皱眉纹”）暂时改善。经过十年成功的“非标签”使用后，在两项相同的、大型的、多中心的、随机的、双盲的、安慰剂对照的关键试验中，共537名受试者（大多数为女性），这些受试者在面部活动时有中度或重度眉间纹，已证明保妥适（总剂量20生物单位）治疗眉间皱纹的疗效和耐受性。基于受试者和医生的评估，在注射后第7天开始的120天注射后随访期内，每次随访时保妥适改善眉间纹的效果均优于安慰剂。注射后第30天出现峰值效应，两项研究合并后，80%的受试者在最大皱眉时皱纹严重程度降至轻度或无，这是由医生评估得出的，89%的受试者自评眉间纹外观至少有中度（≥50%）改善。在这些试验的非对比性扩展研究中，在第二次和第三次治疗后，有更高比例的受试者对保妥适注射有反应的趋势。用于眉间纹的保妥适注射耐受性良好。头痛是最常见的不良事件，在两项关键研究中其发生频率与安慰剂相似（分别为13%和18%）。3.2%的保妥适接受者出现暂时性上睑下垂；然而，随着重复治疗，这种不良事件的发生率趋于降低。总之，保妥适注射为改善眉间皱纹提供了一种方便、有效且耐受性良好的治疗方法。需要重复注射以维持长期效果；然而，对于希望避免更大型手术的个体来说，这种技术显然是一个有吸引力的选择。
