两种商业化肉毒毒素 A 制剂在肌肉和无汗效果方面的比较：一项前瞻性、双盲、随机、多中心研究。

Fields of muscular and anhidrotic effects of 2 botulinum toxin-A commercial preparations: a prospective, double-blind, randomized, multicenter study.

机构信息

*Brazilian Center for Studies in Dermatology, Porto Alegre, Brazil; †Cosmetic Dermatology, Department of Dermatology, Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre, Brazil; ‡Department of Internal Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.

出版信息

Dermatol Surg. 2015 Jan;41 Suppl 1:S110-8. doi: 10.1097/01.DSS.0000452645.76270.88.

DOI:10.1097/01.DSS.0000452645.76270.88

PMID:25548839

Abstract

BACKGROUND

Longevity of effects and dose equivalence of different botulinum toxin type A (BoNT-A) preparations need to be better clarified because BoNT-A units are manufacturer-specific. These points are of particular importance for new brands emerging in the market.

OBJECTIVE

To assess the field of muscular and anhidrotic effects of 2 commercial preparations of BoNT-A (incobotulinumtoxinA: Xeomin [XEO]; abobotulinumtoxinA: Dysport [DYS]) administered to the upper third of the face.

METHODS

Patients were randomized for the side of the forehead (left or right) in which the products were administered. All were treated receiving BoNT-A injections in 10 points (5 on each side) at a dose equivalence of 1.0:2.5 U (XEO:DYS). Clinical assessments and Minor test were performed at baseline and Days 28, 84, 112, and 140. Electromyography was performed at baseline and Days 28 and 140, and ultrasound was performed only at baseline.

RESULTS

Eighty patients were enrolled in 2 research centers. Xeomin and DYS presented similar results regarding fields of muscular effects. However, a larger field of anhidrotic effects was found for DYS. There was a positive correlation between the muscle thickness and electromyography results.

CONCLUSION

The results of this study suggest that a lower dose equivalence between DYS and XEO could be established.

摘要

背景

不同肉毒毒素 A （BoNT-A）制剂的作用持续时间和剂量等效性需要更好地阐明，因为 BoNT-A 单位是特定于制造商的。这些要点对于市场上出现的新品牌尤为重要。

目的

评估两种商业 BoNT-A 制剂（IncobotulinumtoxinA：Xeomin [XEO]；AbobotulinumtoxinA：Dysport [DYS]）在上半面部肌肉和无汗效果的领域。

方法

患者随机分配至前额的一侧（左侧或右侧）接受产品治疗。所有患者均接受 10 点 BoNT-A 注射（每侧 5 点），剂量等效比为 1.0:2.5 U（XEO:DYS）。在基线和第 28、84、112 和 140 天进行临床评估和 Minor 测试。在基线和第 28 和 140 天进行肌电图检查，仅在基线时进行超声检查。