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A型肉毒毒素治疗鱼尾纹的临床疗效持续时间:两项多中心、随机、对照试验的结果

Duration of Clinical Efficacy of OnabotulinumtoxinA in Crow's Feet Lines: Results from Two Multicenter, Randomized, Controlled Trials.

作者信息

Baumann Leslie, Dayan Steven, Connolly Simon, Silverberg Nancy, Lei Xiaofang, Drinkwater Adrienne, Gallagher Conor J

机构信息

*Baumann Cosmetic & Research Institute, Miami, Florida; †DeNova Research, Chicago, Illinois; ‡The Private Clinic, Glasgow, United Kingdom; §Silverberg Surgical & Medical Group, Private Practice, Newport Beach, California; ‖Allergan plc, Irvine, California; ¶Peloton Advantage, Parsippany, New Jersey.

出版信息

Dermatol Surg. 2016 May;42(5):598-607. doi: 10.1097/DSS.0000000000000757.

Abstract

BACKGROUND

Duration of esthetic treatments may contribute to subject satisfaction.

OBJECTIVE

Describe response duration with onabotulinumtoxinA in crow's feet lines (CFL) and the association of duration with perception of improvement.

METHODS

Subjects from 2 double-blind, placebo-controlled trials received onabotulinumtoxinA 24 U in CFL; Study 2 subjects could also receive 20 U in glabella. At Day 30, responders achieved ≥1-grade improvement in Facial Wrinkle Scale (FWS) scores. Median duration of effect for responders and for responders stratified by Subject's Global Assessment of Change in CFL (SGA-CFL) was determined.

RESULTS

Of 1,362 subjects, 833 received onabotulinumtoxinA. In Study 2, 305 subjects also received 20 U in glabella. In Study 1 (150-day follow-up), per investigator and subject assessments, respectively, median response duration was 125 and 144 days for dynamic lines and 137 and 148 days for static lines. Median response duration for dynamic and static lines in Study 2 (120-day follow-up) was 119 to 121 days per investigator and subject assessments. Subjects reporting greater improvement on the SGA-CFL tended to have a longer duration of response on investigator FWS scores at maximum smile.

CONCLUSION

Response duration with onabotulinumtoxinA in CFL was ≥4 months. Subject perception of CFL improvement may be associated with response duration.

摘要

背景

美容治疗的持续时间可能会影响受试者的满意度。

目的

描述注射A型肉毒毒素治疗鱼尾纹(CFL)的反应持续时间,以及持续时间与改善感知之间的关联。

方法

来自2项双盲、安慰剂对照试验的受试者在鱼尾纹处接受24单位A型肉毒毒素注射;研究2的受试者还可在眉间接受20单位注射。在第30天,有反应者面部皱纹量表(FWS)评分改善≥1级。确定了有反应者以及按受试者对鱼尾纹变化的整体评估(SGA-CFL)分层的有反应者的中位起效持续时间。

结果

1362名受试者中,833人接受了A型肉毒毒素注射。在研究2中,305名受试者还在眉间接受了20单位注射。在研究1(150天随访)中,根据研究者和受试者的评估,动态纹的中位反应持续时间分别为125天和144天,静态纹为137天和148天。在研究2(120天随访)中,根据研究者和受试者的评估,动态纹和静态纹的中位反应持续时间为119至121天。在SGA-CFL上报告改善程度更高的受试者,在最大微笑时,其研究者FWS评分的反应持续时间往往更长。

结论

A型肉毒毒素治疗鱼尾纹的反应持续时间≥4个月。受试者对鱼尾纹改善的感知可能与反应持续时间有关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9119/5414775/38b3ff84a8f6/ds-42-598-g003.jpg

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