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注射用A型肉毒毒素治疗韩国成年人眉间皱纹的有效性和耐受性:一项上市后观察性研究

Efficacy and Tolerability of IncobotulinumtoxinA for Treating Glabellar Frown Lines in Korean Adults: A Postmarketing Observational Study.

作者信息

Park Je-Young, Sung Nak-Kwan, Pitt Jonathan M

机构信息

*Oracle Dermatology and Plastic Surgery Center, Seoul, Korea; †Sung Nak Kwan Plastic Surgery, Seoul, Korea; ‡4Clinics, Paris, France.

出版信息

Dermatol Surg. 2017 Dec;43 Suppl 3:S304-S311. doi: 10.1097/DSS.0000000000001330.

Abstract

BACKGROUND

IncobotulinumtoxinA is safe and effective in Caucasian adults. Its effects have been less documented in Asian adults.

OBJECTIVE

To describe the efficacy and tolerability of incobotulinumtoxinA for treating glabellar frown lines (GFLs) in South Korean adults.

METHODS

South Korean adults aged 18 to 65 years with moderate-to-severe GFLs received a single dose of 10 to 28 U incobotulinumtoxinA during routine clinical practice. After 30 ± 14 days, investigators assessed the efficacy using the Global Aesthetic Improvement Scale and rated tolerability using a 4-point scale.

RESULTS

Six hundred seventy-three subjects were enrolled, of which 528 completed the study according to protocol. Glabellar frown lines improved in 98.7% (521/528) of subjects, with 30.8% of cases rated as "very much improved" and 47.4% as "much improved." The extent of improvement was unaffected by sex, age, and weight but was greater when the time between GFL identification and treatment was <6 months (p < .001) and when concomitant aesthetic nondrug treatments were used (p < .001). For 94% of subjects, tolerability was good or very good. All reported adverse events were transient and mild or moderate in severity.

CONCLUSION

IncobotulinumtoxinA was well tolerated and effective for treating moderate-to-severe GFLs in Korean adults irrespective of age, sex, or weight.

摘要

背景

因可 BotulinumtoxinA 在高加索成年人中安全有效。其在亚洲成年人中的效果记录较少。

目的

描述因可 BotulinumtoxinA 治疗韩国成年人眉间皱纹(GFLs)的疗效和耐受性。

方法

18 至 65 岁患有中度至重度眉间皱纹的韩国成年人在常规临床实践中接受 10 至 28U 的单剂量因可 BotulinumtoxinA。30±14 天后,研究者使用全球美学改善量表评估疗效,并使用 4 分制对耐受性进行评分。

结果

共纳入 673 名受试者,其中 528 名按方案完成研究。98.7%(521/528)的受试者眉间皱纹得到改善,30.8%的病例评为“改善非常明显”,47.4%评为“改善明显”。改善程度不受性别、年龄和体重影响,但在眉间皱纹确诊与治疗间隔时间<6 个月时(p<.001)以及使用非药物美学联合治疗时(p<.001)改善程度更大。94%的受试者耐受性良好或非常良好。所有报告的不良事件均为短暂性,严重程度为轻度或中度。

结论

无论年龄、性别或体重如何,因可 BotulinumtoxinA 治疗韩国成年人中度至重度眉间皱纹耐受性良好且有效。

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