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A型肉毒毒素治疗亚洲人额部横纹的疗效和安全性:一项临床、前瞻性、干预性、自身对照研究。

The efficacy and safety of neubotulinumtoxinA for the treatment of forehead horizontal lines in Asians - A clinical, prospective, interventional, split-face study.

机构信息

Asia-Pacific Aesthetic Academy, Seoul, Hong Kong.

Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 FOUR Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, South Korea.

出版信息

Skin Res Technol. 2024 Apr;30(4):e13644. doi: 10.1111/srt.13644.

Abstract

BACKGROUND

Botulinum toxin injections are widely sought after in the field of medical aesthetics, offering consumers a variety of brand choices. Two commonly available botulinum toxin products, onabotulinumtoxinA and neubotulinumtoxinA, are featured in numerous clinics, leading many to question whether there are discernible differences in results, given their varying price ranges.

OBJECTIVE

To evaluate the efficacy and safety of neubotulinumtoxinA for the treatment of forehead horizontal lines.

METHODS

A 12-week prospective, single-centre, interventional split-face study was conducted, including 30 subjects. These enrolled subjects received a single treatment session, with neubotulinumtoxinA applied to the left side of the forehead and onabotulinumtoxinA to the right side. A superficial injection was performed in all individuals, where the product was injected subdermally in the frontalis muscle. Evaluation was conducted at baseline, 7 days, 14, days and 4, 8, and 12 weeks after treatment, both when the eyebrows were at maximum lift and in a resting position. Treatment efficacy was assessed by two physicians and self-assessed by the patients, using the Fitzpatrick Wrinkle Classification system. Adverse events were documented to evaluate safety.

RESULTS

The study found no statistically significant difference in the efficacy of neubotulinum and onabotulinum for treating forehead wrinkles, as indicated by p-values above 0.05 for both static and dynamic conditions. No safety and adverse events were observed in both formulations.

CONCLUSION

This study has demonstrated that neither formulation is inferior to each other in the treatment of forehead horizontal lines.

摘要

背景

肉毒毒素注射在医美领域受到广泛追捧,为消费者提供了多种品牌选择。两种常见的肉毒毒素产品,即肉毒毒素 A(onabotulinumtoxinA)和新型肉毒毒素 A(neubotulinumtoxinA),在众多诊所中都有应用,这使得许多人质疑,鉴于它们的价格差异,在效果上是否存在明显差异。

目的

评估新型肉毒毒素 A 治疗额部横纹的疗效和安全性。

方法

这是一项为期 12 周的前瞻性、单中心、干预性对照面部研究,共纳入 30 名受试者。这些受试者接受了单次治疗,左侧额部注射新型肉毒毒素 A,右侧额部注射肉毒毒素 A。所有患者均进行浅层注射,将产品注射至额肌皮下。在基线、治疗后 7 天、14 天和 4、8、12 周时,当眉毛处于最大提起位置和休息位置时,对治疗效果进行评估。两名医生进行疗效评估,患者进行自我评估,采用 Fitzpatrick 皱纹分级系统。记录不良反应以评估安全性。

结果

研究发现,在治疗额部皱纹的效果方面,新型肉毒毒素 A 和肉毒毒素 A 之间没有统计学上的显著差异,两种制剂在静态和动态条件下的 p 值均大于 0.05。两种制剂均未观察到安全性和不良反应。

结论

本研究表明,两种制剂在治疗额部横纹方面没有优劣之分。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e9/10966542/d762d706e0c7/SRT-30-e13644-g002.jpg

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