Division of Plastic Surgery, Northwestern University, Chicago, Illinois, USA.
Aesthet Surg J. 2011 Jan;31(1):95-109. doi: 10.1177/1090820X10391213.
Characteristics of the aging face include soft tissue atrophy, loss of skin elasticity resulting in excess facial skin, and gravitational descent or ptosis of facial soft tissues. Poly-L-lactic acid (PLLA) is a synthetic biodegradable polymer that provides soft tissue augmentation through stimulation of an inflammatory tissue response with subsequent collagen deposition.
The authors discuss the special considerations inherent in facial aging, describe the mechanism of action and indications for a new PLLA filler under consideration for Food and Drug Administration (FDA) approval (Sculptra Aesthetic, sanofi-aventis US, Bridgewater, New Jersey), and detail the results of a two-year off-label pilot study with the product.
The senior author (LAC) treated 106 patients with PLLA in an off-label indication, as part of a pilot study while Sculptra Aesthetic was being evaluated for FDA approval for cosmetic indications. All patients were followed up for two years to help develop a protocol for injection technique.
The age range of patients in this series was 40 to 78 years. Three patients were male and 103 were female. Patients received an average injection of 1.6 vials per session, over an average of 2.3 sessions, to achieve volume restoration in the tear trough, midface, malar region, nasolabial folds, prejowl area, mandibular border, and mandibular angle. The authors we achieved 100% follow-up with 99.1% patient satisfaction. The rate of nodule formation was 4.7% at a minimum follow-up of two years.
Because of its unique mechanism of action, PLLA for nonsurgical facial rejuvenation requires meticulous injection technique with special considerations for optimizing outcomes and minimizing adverse events.
衰老面容的特征包括软组织萎缩、皮肤弹性丧失导致多余的面部皮肤、以及面部软组织的重力下降或下垂。聚左旋乳酸(PLLA)是一种合成可生物降解的聚合物,通过刺激炎症组织反应,随后胶原蛋白沉积,提供软组织填充。
作者讨论了与面部衰老相关的特殊考虑因素,描述了一种新的 PLLA 填充剂的作用机制和适应证,该填充剂正在考虑获得美国食品和药物管理局(FDA)的批准(Sculptra 美学,赛诺菲-安万特美国,新泽西州桥水),并详细介绍了该产品两年的标签外试验研究结果。
资深作者(LAC)在标签外适应证下用 PLLA 治疗了 106 例患者,作为 Sculptra 美学正在接受 FDA 批准用于美容适应证评估的试点研究的一部分。所有患者均随访两年,以帮助制定注射技术方案。
该系列患者的年龄范围为 40 至 78 岁。3 例为男性,103 例为女性。患者平均每次治疗注射 1.6 瓶,平均 2.3 次,以实现泪沟、中面部、颊部、鼻唇沟、颏下区域、下颌缘和下颌角的体积恢复。作者实现了 100%的随访,患者满意度为 99.1%。在至少两年的随访中,结节形成率为 4.7%。
由于其独特的作用机制,用于非手术面部年轻化的 PLLA 需要精心的注射技术,特别要考虑优化效果和最小化不良反应的因素。