Hoffmann Klaus
Ruhr-University Bochum, St, Josef Hospital, Bochum, Germany.
BMC Dermatol. 2009 Aug 27;9:9. doi: 10.1186/1471-5945-9-9.
Facial volume loss contributes significantly to facial aging. The 20-mg/mL hyaluronic acid (HA) formulation used in this study is a smooth, highly cohesive, viscous, fully reversible, volumizing filler indicated to restore facial volume. This first prospective study evaluated use in current aesthetic clinical practice.
A pan-European evaluation conducted under guidelines of the World Association of Opinion and Marketing Research, the trial comprised a baseline visit (visit 1) and a follow-up (visit 2) at 14 +/- 7 days posttreatment. Physicians photographed patients at each visit. Each patient was treated with the 20-mg/mL HA volumizing filler as supplied in standard packaging. Procedural details, aesthetic outcomes, safety, and physician and patient ratings of their experience were recorded.
Fifteen physicians and 70 patients (91% female; mean age: 50 years) participated. Mean volume loss at baseline was 3.7 (moderate) on the Facial Volume Loss Scale. Local anesthesia was used in 64.3% of cases. Most injections (85%) were administered with needles rather than cannulas. Of the 208 injections, 59% were in the malar region, primarily above the periosteum. Subcutaneous injections were most common for other sites. The mean total injection volume per patient was 4.6 mL. The mean volume loss score declined significantly (P < .001) to 2.1 at visit 2. On the Global Aesthetic Improvement Scale, 88% and 76% of the treatments were rated very much improved or much improved by physicians and patients, respectively. Of the physicians, 95.6% rated this HA filler as very or fairly easy to use. Similarly, 92% of patients were very likely or quite likely to return for treatment; nearly all (98%) would recommend this treatment to friends. Transient (mean duration: 5.5 days) injection-site adverse events (AEs) occurred in 24 patients. Bruising was the most common AE.
The 20-mg/mL smooth, highly cohesive, viscous, volumizing HA filler was effective, well tolerated, and easy to use in current clinical practice. Participants were very likely to recommend this product to colleagues and friends, and patients would be very or quite likely to request this product for future treatments.
面部容量减少是面部衰老的重要因素。本研究中使用的20mg/mL透明质酸（HA）制剂是一种质地光滑、高度黏附、黏稠、完全可逆的填充剂，用于恢复面部容量。这是第一项评估其在当前美容临床实践中应用情况的前瞻性研究。
该试验在世界民意与市场研究协会的指导下进行了泛欧洲评估，包括一次基线访视（访视1）和治疗后14±7天的随访（访视2）。医生在每次访视时为患者拍照。每位患者均接受标准包装提供的20mg/mL HA填充剂治疗。记录治疗细节、美学效果、安全性以及医生和患者对治疗体验的评分。
15名医生和70名患者（91%为女性；平均年龄：50岁）参与了研究。根据面部容量减少量表，基线时平均容量减少程度为3.7（中度）。64.3%的病例使用了局部麻醉。大多数注射（85%）使用的是针头而非套管。在208次注射中，59%注射于颧部区域，主要在骨膜上方。其他部位最常见的是皮下注射。每位患者平均总注射量为4.6mL。访视2时，平均容量减少评分显著下降（P<0.001）至2.1。在全球美学改善量表中，医生和患者分别将88%和76%的治疗评为改善非常显著或显著改善。95.6%的医生认为这种HA填充剂使用起来非常或相当容易。同样，92%的患者非常可能或比较可能再次接受治疗；几乎所有患者（98%）都会向朋友推荐这种治疗。24例患者出现了短暂性（平均持续时间：5.5天）注射部位不良事件（AE）。瘀斑是最常见的AE。
20mg/mL质地光滑、高度黏附、黏稠的HA填充剂在当前临床实践中有效、耐受性良好且易于使用。参与者非常可能向同事和朋友推荐该产品，患者也非常或比较可能在未来治疗中要求使用该产品。
