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爱贝芙(ArteFill)永久性软组织填充剂:二、适应证和应用。

ArteFill permanent injectable for soft tissue augmentation: II. Indications and applications.

机构信息

Division of Plastic Surgery, University of California, San Diego, 200 West Arbor Drive, San Diego, CA 92103, USA.

出版信息

Aesthetic Plast Surg. 2010 Jun;34(3):273-86. doi: 10.1007/s00266-009-9414-0. Epub 2009 Sep 29.

Abstract

Patients ask for procedures with long-lasting effects. ArteFill is the first permanent injectable approved in 2006 by the FDA for nasolabial folds. It consists of cleaned microspheres of polymethylmethacrylate (PMMA) suspended in bovine collagen. Over the development period of 20 years most of its side effects have been eliminated to achieve the same safety standard as today's hyaluronic acid products. A 5-year follow-up study in U.S. clinical trial patients has shown the same wrinkle improvement as seen at 6 months. Long-term follow-up in European Artecoll patients has shown successful wrinkle correction lasting up to 15 years. A wide variety of off-label indications and applications have been developed that help the physician meet the individual needs of his/her patients. Serious complications after ArteFill injections, such as granuloma formation, have not been reported due to the reduction of PMMA microspheres smaller than 20 microm to less than 1% "by the number." Minor technique-related side effects, however, may occur during the initial learning curve. Patient and physician satisfaction with ArteFill has been shown to be greater than 90%.

摘要

患者寻求持久效果的治疗方法。ArteFill 是 2006 年 FDA 批准的首款用于鼻唇沟的永久性注射填充剂,由聚甲基丙烯酸甲酯(PMMA)的净化微球悬浮于牛胶原蛋白中组成。经过 20 年的发展,其大多数副作用已被消除,以达到与当今透明质酸产品相同的安全标准。在美国临床试验患者的 5 年随访研究中,与 6 个月时相比,皱纹改善情况相同。在欧洲 Artecoll 患者的长期随访中,成功纠正皱纹长达 15 年。已经开发出多种未经批准的适应症和应用方法,有助于医生满足患者的个体需求。由于将小于 20 微米的 PMMA 微球减少到“小于 1%”,因此 ArteFill 注射后并未出现严重的并发症,例如肉芽肿形成。然而,在初始学习曲线期间可能会出现轻微的与技术相关的副作用。患者和医生对 ArteFill 的满意度大于 90%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/42ce/2872008/1b153a85ba26/266_2009_9414_Fig1_HTML.jpg

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