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在眉间线采用液体配方阿博特菌素 A 治疗后,患者满意度显著提高:来自 3 期临床试验的 FACE-Q 结果。

Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.

机构信息

Iena Plastic Surgery Clinic, Paris, France.

Rzany and Hund, Berlin, Germany.

出版信息

Aesthet Surg J. 2020 Aug 14;40(9):1000-1008. doi: 10.1093/asj/sjz248.

DOI:10.1093/asj/sjz248
PMID:31550352
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7427150/
Abstract

BACKGROUND

The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection.

OBJECTIVES

The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance.

METHODS

This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up.

RESULTS

Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: "how rested your face looks" (P < 0.0001-0.0415), "I feel okay about myself" (P = 0.0011-0.0399), and "I feel attractive" (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigators' live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = -0.41 and r = -0.36 [both P < 0.0001], respectively).

CONCLUSIONS

Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.

摘要

背景

FACE-Q 患者报告结局评估了患者对面部美容程序的体验/结果。最近一项关于 abobotulinumtoxinA(ASI,液体配方)的试验是我们所知的第一个评估皱眉线(GL)注射后对 FACE-Q 满意度的试验。

目的

作者旨在通过 3 个 FACE-Q 量表评估 ASI 治疗 GL 的患者满意度:面部外观、心理幸福感和衰老外观。

方法

这是一项为期 6 个月的 III 期、随机、双盲、安慰剂对照试验(NCT02353871),评估 ASI 50 单位治疗中重度 GL 的成年人。

结果

与安慰剂相比,在所有随访访视中,接受 ASI 治疗(N = 125)的患者在所有随访访视中(直至第 148 天,即 5 个月;P < 0.0001-0.0037)、心理幸福感(P < 0.0001-0.0279)和衰老外观(除第 148 天外,P < 0.0001-0.0409)的面部外观满意度最小平方均数变化具有统计学意义。在所有随访访视中,除了第 148 天(P < 0.0001-0.0415)外,个别项目的差异(ASI 与安慰剂)均具有统计学意义:“你的面部看起来有多休息”(P < 0.0001-0.0415)、“我对自己感觉良好”(P = 0.0011-0.0399)和“我觉得自己有吸引力”(P < 0.0001-0.0102)。衰老外观评分的最大最小平方均数(标准误差)变化为-1.4(0.3;ASI)和-0.3(0.4;安慰剂)。研究人员对最大皱眉时 GL 的现场评估与 FACE-Q 面部外观和心理量表的改善显著相关(所有患者:r = -0.41 和 r = -0.36 [均 P < 0.0001])。

结论

接受 ASI 治疗的患者在衰老、面部外观以及重要的心理幸福感方面的满意度显著提高,在注射后 5 至 6 个月时可观察到。结果支持 ASI 的疗效持续时间长,并在未来的试验和临床实践中使用 FACE-Q。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7465/7427150/32f756ce2580/sjz248f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7465/7427150/4a883e470400/sjz248f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7465/7427150/2a49b4bbb7de/sjz248f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7465/7427150/32f756ce2580/sjz248f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7465/7427150/4a883e470400/sjz248f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7465/7427150/2a49b4bbb7de/sjz248f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7465/7427150/32f756ce2580/sjz248f0003.jpg

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2
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A型肉毒杆菌毒素制剂治疗女性眉间纹的比较:一项双盲随机临床试验
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