Lowe N J
Cranley Clinic, London, UK, and UCLA School of Medicine, Los Angeles, CA, USA.
J Eur Acad Dermatol Venereol. 2006 May;20 Suppl 1:2-6. doi: 10.1111/j.1468-3083.2006.01515.x.
Injectable poly-L-lactic acid (PLLA; Sculptra) is widely used throughout Europe and the USA to restore volume in depressed areas of the face by stimulating neocollagenesis. Injectable PLLA was previously marketed as New-Fill, which was often injected incorrectly and at too high a concentration, resulting in some physicians losing confidence in this product. Today, Sculptra is still regarded with a degree of scepticism by some physicians, due to direct or indirect experience with New-Fill. Sculptra, both in formulation and use, is vastly superior to New-Fill and clinical experience with this product dispels the myths associated with the earlier types of injectable PLLA.
PLLA is a very safe, biodegradable compound that has been used in a wide range of medical devices for the last 30 years. In injectable form a good safety profile has been proven; however, when the device is overconcentrated, localized overstimulation of the fibroblasts can result in the formation of small lumps (subcutaneous papules), which are non-pathological but nevertheless palpable by the patient. Physicians must also be trained in the injection of this device, as incorrect injection technique can cause device-related adverse events.
New product guidelines have ensured that problems with PLLA concentration have been countered, and tried and tested injection techniques have been shown to ameliorate device-related adverse events, both of which are dispelling the myths associated with modern injectable PLLA.
可注射聚左旋乳酸(PLLA;塑然雅)在欧洲和美国被广泛用于通过刺激新胶原生成来恢复面部凹陷区域的容积。可注射PLLA以前以纽肤莱的名称销售,其注射方式常常不正确且浓度过高,导致一些医生对该产品失去信心。如今,由于对纽肤莱有直接或间接的体验,一些医生对塑然雅仍持一定程度的怀疑态度。塑然雅在配方和使用方面都远优于纽肤莱,该产品的临床经验消除了与早期可注射PLLA相关的误解。
PLLA是一种非常安全的可生物降解化合物,在过去30年中已被用于广泛的医疗设备。其注射剂型已被证明具有良好的安全性;然而,当制剂浓度过高时,成纤维细胞的局部过度刺激会导致小肿块(皮下丘疹)形成,这些肿块虽无病理学意义,但患者仍可触及。医生也必须接受该制剂注射方面的培训,因为不正确的注射技术可能导致与制剂相关的不良事件。
新的产品指南已确保PLLA浓度问题得到解决,并且经过试验和验证的注射技术已被证明可改善与制剂相关的不良事件,这两者都在消除与现代可注射PLLA相关的误解。