Belotero(新型透明质酸填充剂)
新型透明质酸Belotero在2011年末就已经获得美国FDA的审批,使用一年来,Belotero效果良好。据专家介绍,Belotero最适于治疗嘴唇、脸颊和鼻唇沟细纹,其副作用相对其他填充剂来说,是最好的。不过,也并非没有缺点。目前,还没有完美无缺的填充剂。
现在,在一些初具规模的整形外科诊所里,已经可以使用最新的透明质酸填充物Belotero,这种填充物可以对于嘴唇、脸颊和鼻唇沟的皱纹有很好的填充作用。Belotero也因此被PDA批准为中度甚至严重面部皱纹解决方案。
专家解读Belotero填充剂
Belotero是一种新型的透明质酸皮肤填充剂,声称可以减少其他填充物的面部凹凸不平的副作用。注射皮肤填充剂也被称为液体整容,这些填充剂可以软化面部皱纹、使人恢复青春而且无需修复时间,相比于整形外科手术,Belotero等皮肤填充剂的成本更低,不过,一般都需要多次注射。
Belotero是第一个单相的透明质酸填充剂,在生产过程中,通过各种技术,使产品的颗粒大小均匀,这样更容易注入。Belotero最理想的应用部位是嘴唇、眼睛和额头附近的细纹。不过,在使用Belotero的同时,对于其他的透明质酸要小心使用,否则可能会导致皮肤变色。
整形技术正在不断进步,整形外科在填充剂的选择上也更广泛,但是,目前还没有任何填充剂可以解决所有患者的任何问题。即使是最先进的Belotero也是有缺点的,因此,整形医生会针对每个病人的要求,制定一个详细的个性化治疗计划。
注射整形已成为整形美容界炙手可热的项目,除了应用较广泛的Juvederm透明质酸和Restalyne透明质酸外,现在市面上又出现了一种新的透明质酸注射填充剂——Belotero。早在2005年,这种填充剂就已获得CE认证,在欧洲国家被广泛应用,但2011年11月14日才通过美国FDA的审批,商品名为Belotero
Balance。针对填充剂市场的这种最新产品,相信大家会有以下疑问:
Belotero是什么?
Belotero是一种单相交联透明质酸凝胶,由德国梅尔茨公司(Merz Aesthetics)推出,可以暂时性治疗皱纹及细纹或者增加身体不同部位的容积。Belotero真皮填充剂根据作用范围的不同,主要有三种不同的规格:Belotero Soft;Belotero Basic;Belotero Intense。根据Merz的官方网站显示的信息,Belotero系列透明质酸的应用范围如下:
①Belotero Soft:用于填充表浅皱纹,包括口周皱纹、唇联合处皱纹、鱼尾纹及前额皱纹。
②Belotero® Basic:扩充容积的理想产品,用于填充深度皱纹、丰唇、面部轮廓、鼻唇褶、眉间纹以及衰老性或外伤性面部凹陷的修复。
③Belotero Intense:用于填充更深层次的皱纹。
Belotero透明质酸填充剂
Belotero与其他的填充剂有何不同?
Merz公司采用内聚稠密基质技术(Cohesive Polydensified Matrix,CPM)制造Belotero透明质酸,使得这种填充剂具有与众不同的弹性。美国FDA批准Belotero透明质酸的应用范围包括:填充面部中度至重度的皱纹及褶皱,尤其是口周与鼻部周围,还可以暂时性增加皮下容积,令皮肤表面更加光滑。
Belotero注射技术的培训医师Z. Paul Lorenc博士指出,这种产品比其他的填充剂质地更丝滑,这使得它非常适合填充线纹及唇部。他还指出,这种质地也使得Belotero的注射对周围组织的创伤更少。
此外,制造商Merz公司表示,Belotero与组织的相容性较好,因此被注射到治疗部位后,不会像其他产品那样会轻而易举地被触摸或感觉到。
Belotero可以注射至哪些部位?
美国西棕榈滩皮肤科医师Kenneth Beer博士说,由于Belotero的质地丝滑,因此非常适合唇部以上细纹或鱼尾纹的填充,还可以用于其他皱纹的填充。实际上,Beer博士发现,在较深的皱纹部位注射足够剂量的Belotero,能产生非常自然的效果。
Belotero的效果如何?
尽管要收集到更多美国医生应用Belotero的术前及术后照片还为时过早,不过Beer博士已经和我们分享了他用Belotero填充唇部的效果对比图:
Belotero的效果可以维持多久?
唇部注射Belotero的术前及术后对比图
在FDA的双盲研究中,2/3使用过Belotero的测试对象在注射这种产品的9个月之后,去皱效果依然明显。大部分受术者往往会将随访预约在在术后6个月至1年。Belotero的注射过程一般需要20分钟左右。
注射Belotero有何不良反应?
在试验研究中,受术者没有出现严重的不良反应。不过,使用其他填充剂时并不罕见的中度淤血和肿胀这样的轻微副作用在Belotero的试验受术人群中也有出现。除此之外,不良反应还有:局部发红、局部瘙痒、注射点的疼痛及组织发硬。
SAFETY INFORMATION FOR BELOTERO BALANCE DERMAL FILLER
Indication: BELOTERO BALANCE is FDA-approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.
Contraindications: BELOTERO BALANCE should not be used in patients with severe allergies manifested by a history of anaphylaxis, with a history or presence of multiple severe allergies. BELOTERO BALANCE contains a trace amount of gram-positive bacterial proteins, and is contraindicated in patients with a history of allergies to such material. BELOTERO BALANCE must not be implanted into blood vessels.
Warnings: Use of BELOTERO BALANCE at specific sites in which an active inflammatory process (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled. BELOTERO BALANCE must not be injected into blood vessels of any size. Introduction of BELOTERO BALANCE into the vasculature may occlude the vessels and can cause infarction of overlying tissue or embolization with resultant necrosis of potentially large areas of distant tissue such as the lip or the nose. Injection site responses to BELOTERO BALANCE® have been observed, consisting mainly of short-term inflammatory symptoms starting early after treatment and with 7 days duration or less.
Precautions: The safety or effectiveness of BELOTERO BALANCE for the treatment of dermal contour defects other than nasolabial folds, such as use in the lips, has not been established in controlled clinical studies.
The safety of BELOTERO BALANCE for use during pregnancy, in breastfeeding females, or in patients under 21 years has not been established. As with all transcutaneous procedures, BELOTERO BALANCE injection carries a risk of infection. Patients who are using substances that reduce coagulation, such as aspirin, non-steroidal anti-inflammatory drugs, and warfarin may, as with any injection, experience increased bruising or bleeding at injection sites. Patients should inform their physicians if they are taking such substances. Laser treatment, chemical peeling, or any other
procedure based on active dermal response performed after treatment with BELOTERO BALANCE may increase the risk of an inflammatory reaction at the injection site. Similarly, the administration of BELOTERO BALANCE before the skin has healed completely after such a procedure may also increase the risk of inflammatory reactions. Exposure of the treated area to excessive sun, UV lamp exposure, and extreme cold weather should be minimized until any initial swelling and redness have resolved and puncture sites have healed.
Adverse Events: The most common side effects seen after injection were swelling, bruising, redness, and hardening that resolve within one week.
More rare side effects may include swelling that lasts longer, unevenness or firmness in the area injected, and as with any injection, there may be a risk of infection.
Important: For full safety information, please visit www.Belotero.com or call Merz Aesthetics Customer Service at 866-862-1211
Caution: Rx only