新型透明质酸填充剂（YYS 系列）一年安全性评估：一项前瞻性多中心观察研究。

IF 2.5 3区医学 Q2 DERMATOLOGY

Dermatologic Surgery Pub Date : 2024-08-01 Epub Date: 2024-05-02 DOI:10.1097/DSS.0000000000004190

Su Jung Park, Kwang Ho Yoo

{"title":"新型透明质酸填充剂（YYS 系列）一年安全性评估：一项前瞻性多中心观察研究。","authors":"Su Jung Park, Kwang Ho Yoo","doi":"10.1097/DSS.0000000000004190","DOIUrl":null,"url":null,"abstract":"Background: With the continuous increasing availability of new filler products, each hyaluronic acid filler brand has distinctive pharmacokinetics, which may be associated with different complications. Therefore, the long-term safety of new generations of fillers should be evaluated.Objective: This prospective, multicenter, observational, postmarketing study ( ClinicalTrials.gov identifier: NCT04738019) aimed to investigate the incidence of delayed-onset nodules and adverse reactions after the injection of new hyaluronic acid fillers (YYS series) into the facial skin.Methods: Subjects scheduled to receive an injection YYS series filler were followed up for 52 weeks. The authors aimed to determine the incidence of a self-reported delayed-onset nodule-a visible or palpable nodule or mass at the injection site that was detected beyond the 14th day following the injection-during the 1-year follow-up period.Results: Among the 1,022 subjects who received an injection of the YYS series, the incidences of delayed-onset nodules were 0% for YYS 360, YYS 540, and YYS 720. A 0.21% incidence (1 delayed hypersensitivity reaction) of a delayed-onset adverse reaction was noted for YYS 720, although none were reported for YYS 360 and YYS 540.Conclusion: In this study, a notably low frequency of adverse reactions associated with the YYS series was observed.","PeriodicalId":11289,"journal":{"name":"Dermatologic Surgery","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11288390/pdf/","citationCount":"0","resultStr":"{\"title\":\"One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study.\",\"authors\":\"Su Jung Park, Kwang Ho Yoo\",\"doi\":\"10.1097/DSS.0000000000004190\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: With the continuous increasing availability of new filler products, each hyaluronic acid filler brand has distinctive pharmacokinetics, which may be associated with different complications. Therefore, the long-term safety of new generations of fillers should be evaluated.Objective: This prospective, multicenter, observational, postmarketing study ( ClinicalTrials.gov identifier: NCT04738019) aimed to investigate the incidence of delayed-onset nodules and adverse reactions after the injection of new hyaluronic acid fillers (YYS series) into the facial skin.Methods: Subjects scheduled to receive an injection YYS series filler were followed up for 52 weeks. The authors aimed to determine the incidence of a self-reported delayed-onset nodule-a visible or palpable nodule or mass at the injection site that was detected beyond the 14th day following the injection-during the 1-year follow-up period.Results: Among the 1,022 subjects who received an injection of the YYS series, the incidences of delayed-onset nodules were 0% for YYS 360, YYS 540, and YYS 720. A 0.21% incidence (1 delayed hypersensitivity reaction) of a delayed-onset adverse reaction was noted for YYS 720, although none were reported for YYS 360 and YYS 540.Conclusion: In this study, a notably low frequency of adverse reactions associated with the YYS series was observed.\",\"PeriodicalId\":11289,\"journal\":{\"name\":\"Dermatologic Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11288390/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatologic Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/DSS.0000000000004190\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/5/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatologic Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/DSS.0000000000004190","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/2 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

背景：随着玻尿酸填充剂新品种的不断涌现，每种玻尿酸填充剂都有其独特的药代动力学，可能会引起不同的并发症。因此，应评估新一代填充剂的长期安全性：这项前瞻性、多中心、观察性、上市后研究（ClinicalTrials.gov 标识符：NCT04738019）旨在调查向面部皮肤注射新型透明质酸填充剂（YYS 系列）后迟发结节和不良反应的发生率：方法：对计划注射 YYS 系列填充剂的受试者进行为期 52 周的随访。作者旨在确定在为期 1 年的随访期间，自我报告的延迟性结节--即注射后第 14 天后在注射部位发现的可见或可触及的结节或肿块--的发生率：在 1022 名接受过 YYS 系列注射的受试者中，YYS 360、YYS 540 和 YYS 720 的迟发性结节发生率为 0%。YYS 720 的迟发性不良反应发生率为 0.21%（1 例迟发性超敏反应），而 YYS 360 和 YYS 540 均未报告迟发性不良反应：在这项研究中，观察到与 YYS 系列相关的不良反应发生率明显较低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study.

Background: With the continuous increasing availability of new filler products, each hyaluronic acid filler brand has distinctive pharmacokinetics, which may be associated with different complications. Therefore, the long-term safety of new generations of fillers should be evaluated.

Objective: This prospective, multicenter, observational, postmarketing study ( ClinicalTrials.gov identifier: NCT04738019) aimed to investigate the incidence of delayed-onset nodules and adverse reactions after the injection of new hyaluronic acid fillers (YYS series) into the facial skin.

Methods: Subjects scheduled to receive an injection YYS series filler were followed up for 52 weeks. The authors aimed to determine the incidence of a self-reported delayed-onset nodule-a visible or palpable nodule or mass at the injection site that was detected beyond the 14th day following the injection-during the 1-year follow-up period.

Results: Among the 1,022 subjects who received an injection of the YYS series, the incidences of delayed-onset nodules were 0% for YYS 360, YYS 540, and YYS 720. A 0.21% incidence (1 delayed hypersensitivity reaction) of a delayed-onset adverse reaction was noted for YYS 720, although none were reported for YYS 360 and YYS 540.

Conclusion: In this study, a notably low frequency of adverse reactions associated with the YYS series was observed.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Dermatologic Surgery 医学-皮肤病学

CiteScore

3.10

自引率

16.70%

发文量

547

期刊介绍： Exclusively devoted to dermatologic surgery, the Dermatologic Surgery journal publishes the most clinically comprehensive and up-to-date information in its field. This unique monthly journal provides today’s most expansive and in-depth coverage of cosmetic and reconstructive skin surgery and skin cancer through peer-reviewed original articles, extensive illustrations, case reports, ongoing features, literature reviews and correspondence. The journal provides information on the latest scientific information for all types of dermatologic surgery including: -Ambulatory phlebectomy- Blepharoplasty- Body contouring- Chemical peels- Cryosurgery- Curettage and desiccation- Dermabrasion- Excision and closure- Flap Surgery- Grafting- Hair restoration surgery- Injectable neuromodulators- Laser surgery- Liposuction- Microdermabrasion- Microlipoinjection- Micropigmentation- Mohs micrographic surgery- Nail surgery- Phlebology- Sclerotherapy- Skin cancer surgery- Skin resurfacing- Soft-tissue fillers. Dermatologists, dermatologic surgeons, plastic surgeons, oculoplastic surgeons and facial plastic surgeons consider this a must-read publication for anyone in the field.