Roberta Vasconcelos-Berg, Julia Real, Franziska Wenz, Luiz Eduardo Toledo Avelar
{"title":"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","authors":"Roberta Vasconcelos-Berg, Julia Real, Franziska Wenz, Luiz Eduardo Toledo Avelar","doi":"10.1111/jocd.16560","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Poly-<span>l</span>-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.</p>\n </section>\n \n <section>\n \n <h3> Objective</h3>\n \n <p>To evaluate adverse events in patients treated with immediately reconstituted PLLA-SCA on the face, body, and scars.</p>\n </section>\n \n <section>\n \n <h3> Method</h3>\n \n <p>This 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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>A 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.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>This 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.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>This was a retrospective study of medical records at two medical centers, and trial registration was not required.</p>\n </section>\n </div>","PeriodicalId":15546,"journal":{"name":"Journal of Cosmetic Dermatology","volume":"23 12","pages":"3918-3923"},"PeriodicalIF":2.5000,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jocd.16560","citationCount":"0","resultStr":"{\"title\":\"Safety of the Immediate Reconstitution of Poly-l-Lactic Acid for Facial and Body Treatment—A Multicenter Retrospective Study\",\"authors\":\"Roberta Vasconcelos-Berg, Julia Real, Franziska Wenz, Luiz Eduardo Toledo Avelar\",\"doi\":\"10.1111/jocd.16560\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Poly-<span>l</span>-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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>To evaluate adverse events in patients treated with immediately reconstituted PLLA-SCA on the face, body, and scars.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Method</h3>\\n \\n <p>This 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>A 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>This 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>This was a retrospective study of medical records at two medical centers, and trial registration was not required.</p>\\n </section>\\n </div>\",\"PeriodicalId\":15546,\"journal\":{\"name\":\"Journal of Cosmetic Dermatology\",\"volume\":\"23 12\",\"pages\":\"3918-3923\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-09-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jocd.16560\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cosmetic Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/jocd.16560\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cosmetic Dermatology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/jocd.16560","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Safety of the Immediate Reconstitution of Poly-l-Lactic Acid for Facial and Body Treatment—A Multicenter Retrospective Study
Background
Poly-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.
Objective
To evaluate adverse events in patients treated with immediately reconstituted PLLA-SCA on the face, body, and scars.
Method
This 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.
Results
A 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.
Conclusion
This 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 Registration
This was a retrospective study of medical records at two medical centers, and trial registration was not required.
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.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
