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ATX-101 治疗颏下饱满的疗效和安全性:两项美容实践的回顾性分析。

Efficacy and safety of ATX-101 as a treatment for submental fullness: A retrospective analysis of two aesthetic practices.

机构信息

Department of Dermatology & Skin Science, University of British Columbia, Vancouver, BC, Canada.

West Dermatology, Rancho Santa Margarita, CA, USA.

出版信息

J Cosmet Dermatol. 2020 Jun;19(6):1328-1332. doi: 10.1111/jocd.13165. Epub 2019 Sep 25.

DOI:10.1111/jocd.13165
PMID:31553141
Abstract

BACKGROUND

Submental fullness (SMF) is a common cosmetic concern that can have negative impact on one's self-esteem. ATX-101 has shown promise as a minimally invasive treatment for SMF correction in clinical trials.

AIMS

To assess the safety and efficacy of ATX-101 for SMF correction.

PATIENTS/METHODS: This was a retrospective review of 90 patients from two aesthetic practices who received ATX-101 injections for SMF (January 2016-August 2017). There were no exclusion criteria. Initial SMF severity was assigned using standardized photographs and a validated 5-point scale. Eighty one patients subsequently answered questionnaires regarding improvement, satisfaction, and adverse effects. Degree of SMF correction was also evaluated by the investigator and a blinded reviewer.

RESULTS

Eighty one patients (mean initial submental fullness severity 1.6) received a mean of 1.84 ATX-101 treatment sessions using a median of 2.0 vials per treatment (mean 3.02, range 1-9). Mean Physician Global Aesthetic Improvement Scale scores were 2.73 and 2.25, after the first and second treatments, respectively (P = .04). Mean Subject Goal Aesthetic Improvement Scale scores were 2.7 and 2.25 after the first and second treatments, respectively (P = .01). Sixty-seven percentage of patients were "somewhat" or "very" satisfied. Adverse events were transient and limited to the treatment area.

CONCLUSION

Patients achieved progressive improvement in SMF after the 1st and 2nd treatments, as judged by patients themselves, investigators, and blinded evaluators. These results of SMF correction suggest that significant benefit can be obtained with proper dosing at the initial visit. These data support the efficacy and safety profile of ATX-101 use for SMF correction.

摘要

背景

颏下饱满(SMF)是一种常见的美容问题,会对患者的自尊心产生负面影响。ATX-101 已被证明是一种治疗颏下饱满的微创治疗方法,在临床试验中显示出良好的效果。

目的

评估 ATX-101 治疗 SMF 的安全性和有效性。

患者/方法:这是对两家美容诊所的 90 名患者进行的回顾性研究,这些患者在 2016 年 1 月至 2017 年 8 月期间接受了 ATX-101 注射治疗 SMF。无排除标准。使用标准化照片和经过验证的 5 分制来评估初始颏下饱满的严重程度。81 名患者随后回答了关于改善、满意度和不良反应的问卷。研究者和一位盲法评估者也评估了颏下饱满的矫正程度。

结果

81 名患者(平均初始颏下饱满严重程度为 1.6)接受了平均 1.84 次 ATX-101 治疗,中位数为每治疗 2.0 瓶(平均 3.02,范围 1-9)。第一次和第二次治疗后,医生整体美学改善量表评分分别为 2.73 和 2.25(P=0.04)。第一次和第二次治疗后,患者目标美学改善量表评分分别为 2.7 和 2.25(P=0.01)。67%的患者“有些”或“非常”满意。不良反应是短暂的,仅限于治疗区域。

结论

患者自己、研究者和盲法评估者都认为,在第一次和第二次治疗后,SMF 得到了持续的改善。这些 SMF 矫正结果表明,在初次就诊时适当剂量可以获得显著的益处。这些数据支持 ATX-101 用于治疗 SMF 的疗效和安全性。

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