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一项前瞻性神经生理学对比研究,以评估因可保妥适(IncobotulinumtoxinA)和阿保妥适(AbobotulinumtoxinA)治疗鱼尾纹的疗效及效果持续时间。

A Prospective, Neurophysiologic Comparative Study to Assess the Efficacy and Duration of Effect of IncobotulinumtoxinA and AbobotulinumtoxinA in the Treatment of Crow's Feet.

作者信息

Saybel Anastasia, Artemenko Ada, Nikitin Sergei, Kurenkov Alexei

出版信息

J Drugs Dermatol. 2015 Nov;14(11):1291-6.

PMID:26580879
Abstract

This randomized, rater-blind, split-face study compared the safety and efficacy of incobotulinumtoxinA and abobotulinumtoxinA for the treatment of crow's feet. Nine units of incobotulinumtoxinA were administered to the lateral periorbital region of one side of the face and 27 units of abobotulinumtoxinA to the other in healthy subjects (aged 35-55 years) with moderate-to-severe crow's feet at rest (2-3 points on the 5-point Merz Aesthetics Scale [MAS]). Investigators assessed efficacy using the MAS, while subjects assessed using a 9-point global assessment scale. Secondary objectives included electromyography to assess muscle activity before injection and at 2 weeks, 4 months, and 6 months afterwards. Twenty women were enrolled and 18 completed the study. At rest and maximum smile, at each time point, the mean wrinkle scores were significantly lower (P ≤ 0.05) than baseline for both treatments. No differences were noted between treatments. Responder (≥ 1-point improvement from baseline) rates for both products were 100% and 83% at 2 weeks and 4 months post-treatment, respectively. At 6 months post-treatment, responder rates were 67% and 61% for incobotulinumtoxinA and abobotulinumtoxinA, respectively. For both, the maximum changes in electromyography parameters were observed 2 weeks post-treatment. A response was maintained for 6 months (P ≤ 0.05 vs baseline). Both treatments were well tolerated; only mild adverse events were reported. In conclusion, for treatment of crow's feet, incobotulinumtoxinA and abobotulinumtoxinA (1:3 dose) demonstrated comparable efficacy in terms of magnitude and longevity of effect. Both products demonstrated a high responder rate, with the response being maintained for 6 months in the majority.

摘要

这项随机、评估者盲法、半脸研究比较了incobotulinumtoxinA和abobotulinumtoxinA治疗鱼尾纹的安全性和有效性。在35至55岁、静止时患有中度至重度鱼尾纹(在5分Merz美学量表[MAS]上为2至3分)的健康受试者中,在一侧面部的眶外侧区域注射9单位incobotulinumtoxinA,在另一侧注射27单位abobotulinumtoxinA。研究者使用MAS评估疗效,而受试者使用9分整体评估量表进行评估。次要目标包括在注射前以及注射后2周、4个月和6个月进行肌电图检查以评估肌肉活动。招募了20名女性,18名完成了研究。在静止和最大微笑时,在每个时间点,两种治疗的平均皱纹评分均显著低于基线(P≤0.05)。两种治疗之间未观察到差异。两种产品在治疗后2周和4个月时的有效率(较基线改善≥1分)分别为100%和83%。在治疗后6个月时,incobotulinumtoxinA和abobotulinumtoxinA的有效率分别为67%和61%。对于两者,肌电图参数的最大变化在治疗后2周观察到。疗效维持了6个月(与基线相比P≤0.05)。两种治疗耐受性良好;仅报告了轻度不良事件。总之,对于鱼尾纹的治疗,incobotulinumtoxinA和abobotulinumtoxinA(1:3剂量)在疗效的程度和持续时间方面显示出相当的效果。两种产品均显示出高有效率,大多数情况下疗效维持6个月。

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