Carruthers Jean D, Lowe Nicolas J, Menter M Alan, Gibson John, Eadie Nina
Department of Ophthalmology, University of British Columbia, Vancouver, Canada.
Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62.
The objective of this study was to evaluate the efficacy and safety of botulinum toxin type A for the treatment of glabellar lines. Patients with moderate or severe glabellar lines at maximal frown received intramuscular injections of placebo or 20 U of botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif.) distributed among five injection sites (one in the procerus muscle and two in each corrugator supercilii). Follow-up assessments were performed at 7, 30, 60, 90, and 120 days after injections. Efficacy measures were the physician's rating of glabellar line severity at maximal frown and at rest (none, mild, moderate, or severe) and the patient's global assessment of changes in glabellar lines, from +4 (100 percent better) to -4 (100 percent worse). A total of 273 patients were enrolled (botulinum toxin, 202 patients; placebo, 71 patients). All except five patients (botulinum toxin, two patients; placebo, three patients) completed the study. For the physician's rating at maximal frown, the responder rate (percentage of patients with severity ratings of none or mild in follow-up evaluations) for the botulinum toxin group peaked at 77 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). For the patient's assessment, the responder rate (percentage of patients with scores of +2 or more) for the botulinum toxin group peaked at 89 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). Rates of adverse events were similar for the two groups. The only adverse event with an incidence of >/=5 percent was headache (botulinum toxin, 11 percent; placebo, 20 percent). The incidence of blepharoptosis was 1 percent for the botulinum toxin group. Botulinum toxin type A was remarkably safe and effective in reducing glabellar lines.
本研究的目的是评估A型肉毒杆菌毒素治疗眉间纹的疗效和安全性。在最大皱眉时出现中度或重度眉间纹的患者接受肌肉注射安慰剂或20单位A型肉毒杆菌毒素（保妥适；艾尔建公司，加利福尼亚州欧文市），药物分布于五个注射部位（降眉间肌一处，皱眉肌各两处）。在注射后7、30、60、90和120天进行随访评估。疗效指标包括医生对最大皱眉时和静息时眉间纹严重程度的评分（无、轻度、中度或重度）以及患者对眉间纹变化的整体评估，范围从 +4（改善100%）到 -4（恶化100%）。共有273例患者入组（肉毒杆菌毒素组202例；安慰剂组71例）。除5例患者（肉毒杆菌毒素组2例；安慰剂组3例）外，所有患者均完成了研究。对于医生对最大皱眉时的评分，肉毒杆菌毒素组的缓解率（随访评估中严重程度评分为无或轻度的患者百分比）在第30天时达到峰值，为77%，且在每次随访时均显著高于安慰剂组（p < 0.001）。对于患者的评估，肉毒杆菌毒素组的缓解率（评分在 +2或更高的患者百分比）在第30天时达到峰值，为89%，且在每次随访时均显著高于安慰剂组（p < 0.001）。两组的不良事件发生率相似。唯一发生率≥5%的不良事件是头痛（肉毒杆菌毒素组11%；安慰剂组20%）。肉毒杆菌毒素组上睑下垂的发生率为1%。A型肉毒杆菌毒素在减少眉间纹方面非常安全且有效。
