Rossner Florian, Rossner Mathias, Hartmann Vanessa, Erdmann Ricardo, Wiest Luitgard G, Rzany Berthold
Division of Evidence Based Medicine, Klinik für Dermatologie, Charité Universitätsmedizin Berlin, Berlin, Germany.
J Cosmet Dermatol. 2009 Mar;8(1):14-8. doi: 10.1111/j.1473-2165.2009.00417.x.
Injectable fillers are widely used in aesthetic medicine. Polylactic acid (PLA) is a semipermanent filler that needs to be diluted with sterile water before injection. PLA has been associated with an increased risk of adverse reactions, specifically nodule formation.
To describe adverse reactions to PLA and potential risk factors based on a partly population-based registry over an 8-year period.
The Berlin registry is a partially population-based registry where dermatologists, plastic surgeons, and other specialists are contacted regularly and asked to report patients with adverse events to injectable fillers substances. Additional patients were derived from private practices outside of Berlin. The patients were assessed with a standardized questionnaire. The results were mainly analyzed by descriptive measures.
Twenty-two patients (age, 47.82 +/- 12.65 years) with adverse reactions to PLA were included. The most frequent adverse reaction was nodule formation found in all patients. In 13 (59.1%) of the cases, nodule formation was considered to be severe. Nodules appeared after a mean latency period of 6.00 +/- 5.84 months. The duration of the adverse reactions until the interview was 14.32 +/- 10.13 months. The frequency of patients with adverse events to PLA was found to decrease after new recommendations concerning the dilution of the product were launched.
PLA is an injectable filler substance that may cause subcutaneous nodules in treated patients. Our data support a decreased risk of adverse reactions with an increased dilution. However, nodule formation still appears to be a characteristic feature of PLA.
可注射填充剂在美容医学中广泛应用。聚乳酸（PLA）是一种半永久性填充剂，注射前需用无菌水稀释。PLA与不良反应风险增加相关，尤其是结节形成。
基于一项为期8年的部分人群登记研究，描述PLA的不良反应及潜在风险因素。
柏林登记处是一个部分基于人群的登记处，定期联系皮肤科医生、整形外科医生和其他专家，要求他们报告注射填充剂物质出现不良事件的患者。其他患者来自柏林以外的私人诊所。用标准化问卷对患者进行评估。结果主要通过描述性方法进行分析。
纳入了22例对PLA有不良反应的患者（年龄47.82±12.65岁）。最常见的不良反应是所有患者均出现的结节形成。在13例（59.1%）病例中，结节形成被认为是严重的。结节出现的平均潜伏期为6.00±5.84个月。至访谈时不良反应的持续时间为14.32±10.13个月。在关于该产品稀释的新建议发布后，发现PLA不良事件患者的频率有所下降。
PLA是一种可注射填充剂物质，可能导致接受治疗的患者出现皮下结节。我们的数据支持随着稀释度增加不良反应风险降低。然而，结节形成似乎仍是PLA的一个特征。
