一项关于A型肉毒杆菌毒素治疗眉间纹疗效和安全性的多中心、双盲、随机、安慰剂对照研究。
A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines.
作者信息
Carruthers J Alastair, Lowe Nicholas J, Menter M Alan, Gibson John, Nordquist Marian, Mordaunt Julie, Walker Patricia, Eadie Nina
机构信息
Vancouver Hospital, Vancouver, British Columbia, Canada.
出版信息
J Am Acad Dermatol. 2002 Jun;46(6):840-9. doi: 10.1067/mjd.2002.121356.
BACKGROUND
Botulinum toxin type A (BTX-A) is widely used for facial esthetics but is incompletely studied.
OBJECTIVE
This study was conducted to evaluate the efficacy and safety of BTX-A treatment of glabellar lines.
METHODS
Patients with moderate to severe glabellar lines at maximum frown received intramuscular injections of 20 U BTX-A (BOTOX, Allergan, Inc, Irvine, Calif) or placebo into 5 glabellar sites. Patients were followed up for 120 days after injection. Outcome measures were physician rating of glabellar line severity at maximum frown and rest, patient assessment of improvement, and vital sign and adverse event monitoring.
RESULTS
Two hundred sixty-four patients were enrolled (BTX-A: 203, placebo: 61). There was a significantly greater reduction in glabellar line severity with BTX-A than with placebo (all measures, every follow-up visit; P <.022). The effect was maintained for many patients through day 120. There was a low occurrence (5.4%) of mostly mild blepharoptosis in the BTX-A group.
CONCLUSION
BTX-A injections are safe and effective in reducing the severity of glabellar lines.
背景
A型肉毒毒素（BTX-A）广泛用于面部美容，但相关研究并不充分。
目的
本研究旨在评估BTX-A治疗眉间纹的疗效和安全性。
方法
将20单位BTX-A（保妥适，艾尔建公司，加利福尼亚州欧文市）或安慰剂肌肉注射到5个眉间部位，纳入皱眉时眉间纹为中度至重度的患者。注射后对患者进行120天的随访。观察指标包括医生对最大皱眉和静息状态下眉间纹严重程度的评分、患者对改善情况的评估以及生命体征和不良事件监测。
结果
共纳入264例患者（BTX-A组：203例，安慰剂组：61例）。与安慰剂相比，BTX-A组眉间纹严重程度的改善更为显著（所有指标，每次随访；P<.022）。许多患者至第120天仍维持该效果。BTX-A组上睑下垂发生率较低（5.4%），且大多为轻度。
结论
BTX-A注射在减轻眉间纹严重程度方面安全有效。
Zotero 插件