多中心回顾性研究：聚左旋乳酸用于面部和身体治疗的即时再造安全性

IF 2.3 4区医学 Q2 DERMATOLOGY

Journal of Cosmetic Dermatology Pub Date : 2024-09-17 DOI:10.1111/jocd.16560

Roberta Vasconcelos‐Berg, Julia Real, Franziska Wenz, Luiz Eduardo Toledo Avelar

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引用次数: 0

摘要

背景聚乳酸（PLLA-SCA；Sculptra）作为胶原蛋白生物刺激剂于1999年在欧洲获得批准，2004年在美国获得批准。它是一种冻干制剂，每瓶含 150 毫克 PLLA-SCA，自批准以来，一直被建议在治疗前 72 小时重新配置，这可能会妨碍其在临床实践中的使用。方法这是对2021年1月1日至2021年12月31日期间在两家医疗中心接受立即重组PLLA-SCA美容治疗的患者的医疗记录进行的回顾性分析。其中，228 次治疗（151 名患者）针对面部，39 次治疗（22 名患者）针对身体，7 次治疗（5 名患者）针对疤痕。面部注射的 PLLA-SCA 最终平均浓度为 15.30 毫克/毫升，身体注射的 PLLA-SCA 最终平均浓度为 8.35 毫克/毫升，疤痕注射的 PLLA-SCA 最终平均浓度为 10.53 毫克/毫升。大多数注射都是用钝套管进行的（面部：87.3%；身体：100%；疤痕：57%），在 7 次疤痕治疗中，有 6 次在点阵治疗后局部使用了 PLLA-SCA。一名患者在面部治疗 30 天后出现 PLLA-SCA 结节，注射两次生理盐水后结节消失。最常见的不良反应是瘀伤（面部：6.57%；身体：7.69%）和轻微疼痛（面部：3.07%）。结论本研究报告了用于面部、身体和疤痕的立即重组 PLLA-SCA 的不良反应情况，与使用前 72 小时重组 PLLA-SCA 的不良反应情况相似。

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Safety of the Immediate Reconstitution of Poly‐l‐Lactic Acid for Facial and Body Treatment—A Multicenter Retrospective Study

BackgroundPoly‐l‐lactic acid (PLLA‐SCA; Sculptra) was approved in 1999 in Europe and 2004 in United States as a collagen biostimulator. It is a freeze‐dried preparation containing 150 mg PLLA‐SCA per vial and, since approval, has been recommended to be reconstituted 72 h before treatment, which can hinder its use in clinical practice. In 2021, the manufacturer authorized the reconstitution of PLLA‐SCA immediately before use.ObjectiveTo evaluate adverse events in patients treated with immediately reconstituted PLLA‐SCA on the face, body, and scars.MethodThis was a retrospective analysis of medical records of patients treated with immediately reconstituted PLLA‐SCA for aesthetic purposes from January 1, 2021, to December 31, 2021, at two medical centers.ResultsA total of 274 treatment sessions were conducted on 167 patients (ranging from 1 to 5 sessions per patient). Of these, 228 sessions (151 patients) targeted the face, 39 sessions (22 patients) addressed the body, and 7 sessions (5 patients) focused on scars. The mean final concentration of PLLA‐SCA was 15.30 mg/mL for the face, 8.35 mg/mL for the body, and 10.53 mg/mL for scars. The majority of injections were administered with a blunt cannula (face: 87.3%, body: 100%, scars: 57%), and in 6 out of 7 scar treatments, PLLA‐SCA was additionally applied topically after fractional treatment. One patient developed a PLLA‐SCA nodule 30 days after facial treatment, which resolved after two saline injections. The most common adverse events were bruising (face: 6.57%, body: 7.69%) and mild pain (face: 3.07%). No events required further intervention.ConclusionThis study reports an adverse event profile with immediately reconstituted PLLA‐SCA, used on the face, body, and scars, similar to that reported with PLLA‐SCA reconstituted 72 h prior to use.Trial RegistrationThis was a retrospective study of medical records at two medical centers, and trial registration was not required.

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来源期刊

Journal of Cosmetic Dermatology DERMATOLOGY-

CiteScore

4.30

自引率

13.00%

发文量

818

审稿时长

>12 weeks

期刊介绍： The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.