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一项前瞻性、评价者和受试者双盲研究,比较了 incobotulinumtoxinA 和 onabotulinumtoxinA 治疗鱼尾纹的疗效:一项临床交叉评估。

A prospective rater- and subject-blinded study comparing the efficacy of incobotulinumtoxinA and onabotulinumtoxinA to treat crow's feet: a clinical crossover evaluation.

机构信息

*Dipartimento di Chirurgia Plastica, Istituto Dermatologico Europeo, Milano, Italy; †Scientific Communications and Information, Oxford, United Kingdom.

出版信息

Dermatol Surg. 2015 Jan;41 Suppl 1:S39-46. doi: 10.1097/DSS.0000000000000262.

Abstract

BACKGROUND

Botulinum toxin A products have been used in aesthetics for more than 20 years.

OBJECTIVE

To compare incobotulinumtoxinA with onabotulinumtoxinA in the treatment of crow's feet.

METHODS

This single-center, randomized, prospective, split-face, subject- and rater-blinded study with a clinical crossover evaluation comprised 2 consecutive treatment cycles, each of 3 months' duration separated by 6 months (i.e., a 9-month treatment interval). Fourteen subjects with symmetrical crow's feet were assessed using the Merz 5-point scale for crow's feet, after each treatment with incobotulinumtoxinA (right side of the face) and onabotulinumtoxinA (left side), or vice versa (1:1 dose conversion ratio). The treatment applied to each side of the face was reversed in Cycle 2.

RESULTS

Crow's feet severity at rest and maximum contraction was improved to a similar extent by both treatments, in both cycles and on both sides of the face. Pooled data confirmed these results. Improvements were maintained at the final visit, 3 months after treatment (e.g., left side at maximum contraction-onabotulinumtoxinA mean score: 2.21 [baseline] vs 0.93 [1 month] vs 1.71 [3 months]; incobotulinumtoxinA mean score: 2.21 vs 0.86 vs 1.50).

CONCLUSION

IncobotulinumtoxinA and onabotulinumtoxinA (1:1 dose conversion ratio) were well tolerated, showing comparable efficacy and duration of treatment effect for crow's feet.

摘要

背景

肉毒毒素 A 产品在美容领域已经应用了 20 多年。

目的

比较 incobotulinumtoxinA 与 onabotulinumtoxinA 在治疗鱼尾纹中的效果。

方法

这是一项单中心、随机、前瞻性、分割面部、受试者和评估者双盲研究,具有临床交叉评估,包括 2 个连续的治疗周期,每个周期持续 3 个月,间隔 6 个月(即 9 个月的治疗间隔)。14 名对称出现鱼尾纹的受试者采用 Merz 5 分制鱼尾纹量表进行评估,在接受 incobotulinumtoxinA(右侧面部)和 onabotulinumtoxinA(左侧面部)治疗后,或反之亦然(1:1 剂量转换比),每个治疗周期都对两侧面部进行评估。在第 2 个周期中,将治疗应用于面部的两侧进行反转。

结果

在两个周期和面部两侧,两种治疗方法在休息和最大收缩时均能使鱼尾纹严重程度得到相似程度的改善。汇总数据证实了这些结果。治疗 3 个月后(例如,最大收缩时左侧-onabotulinumtoxinA 平均评分:2.21[基线]vs 0.93[1 个月]vs 1.71[3 个月];incobotulinumtoxinA 平均评分:2.21 vs 0.86 vs 1.50),改善情况仍保持在最后一次访视时。

结论

incobotulinumtoxinA 和 onabotulinumtoxinA(1:1 剂量转换比)均具有良好的耐受性,显示出对鱼尾纹相似的疗效和治疗效果持续时间。

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