Department of Plastic Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Peking University 3rd Hospital, Beijing, China.
J Cosmet Dermatol. 2024 Jun;23(6):1985-1991. doi: 10.1111/jocd.16221. Epub 2024 Mar 15.
Hyaluronic acid (HA) filler treatment is a minimally-invasive alternative to surgery to volumize the cheeks. HA (Restylane Volyme) is a flexible HA filler suited to contouring and volumizing the midface.
This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HA for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HA and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face.
HA was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HA. Additionally, HA was well tolerated, with no unanticipated related adverse events.
This study showed that HA is effective and well tolerated for midface treatment in a Chinese population.
透明质酸（HA）填充剂治疗是一种微创替代手术，用于丰满脸颊。HA（瑞蓝·颜®）是一种灵活的 HA 填充剂，适合于中面部的轮廓塑造和体积填充。
本项随机、评估者设盲、无治疗对照的研究评估了透明质酸在中国受试者中纠正中面部体积不足和中面部轮廓缺陷的效果和安全性。共有 111 名受试者被随机分配至透明质酸组，37 名受试者被分配至无治疗（对照）组。主要终点是末次注射后 6 个月时治疗组的盲法评估者评估的 Medicis 中面部体积量表（MMVS）的反应，以及对照组随机分组后 6 个月时的反应，其中反应定义为两侧面部与基线相比至少改善 1 分。
透明质酸在 6 个月时优于无治疗，达到了主要目标：76%的 MMVS 应答者与 8%的应答者相比，差异为 68%（CI：55.7%-79.4%，p<0.0001）。在末次注射后 12 个月时，这一效果在 51%的患者中持续存在。大多数（≥96%）患者在第 1 个月（使用整体美学改善量表[GAIS]）改善了中面部饱满度的美学外观，这些效果在 12 个月时仍保持在≥80%。3D 摄影测量的体积变化在 1 个月后增加到 3.6mL（接近 3.4mL 的总注射量），并在 12 个月时保持稳定。超过 97%的患者对 HA 治疗后的结果表示满意。此外，HA 耐受性良好，无意外相关不良事件。
本研究表明，透明质酸在中国人群中用于中面部治疗是有效且耐受良好的。
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