Wu Yan, Sun Nan, Xu Yue, Liu Huixian, Zhong Shaomin, Chen Liyang, Li Dong
Department of Dermatology, Peking University First Hospital, Beijing, 100034, China.
Department of Plastic Surgery, Peking University Third Hospital, Beijing, 100191, China.
Arch Dermatol Res. 2016 Apr;308(3):145-51. doi: 10.1007/s00403-016-1630-2. Epub 2016 Feb 29.
Hyaluronic acid fillers are used to improve the appearance of nasolabial folds (NLF). This study aimed to compare the efficacy, safety, and durability of a new hyaluronic acid gel (BioHyalux) versus Restylane for the correction of NLF. This was a multicenter, double-blinded, randomized, controlled, non-inferiority clinical trial involving 88 subjects with moderate to severe NLF. Subjects were randomized to BioHyalux and Restylane on either sides of the NLF. NLF was assessed before and right after injection, and at 1 week, 1, 3, and 6 months. Patients were followed up for 13-15 months to evaluate the durability and long-term safety. A clinically meaningful response was predefined as at least one-point improvement on the Wrinkle Severity Rating Scale, which is a five-point scale. At 6 months, the response rate of BioHyalux was not inferior to that of Restylane (P < 0.05). At the 13-15 months follow-up, the response rate by investigators was 58.0 % on the BioHyalux side versus 63.8 % on the Restylane side. The response rate by subjects showed similar results, which was 56.5 % on the BioHyalux side versus 60.9 % on the Restylane side at 13-15 months. The subjects' Global Aesthetic Improvement Scale (GAIS) showed that most subjects felt improvements on both sides of NLF (P > 0.05) at all time points. At 6 months, 100 % reported improvements on both side; at 13-15 months, 60 % of subjects reported improvements with BioHyalux versus 64 % with Restylane. Adverse events were transient and predominantly mild or moderate in severity including injection site swelling, pain, itching, bruising, and tenderness. BioHyalux had reliable safety and tolerance, and could be an effective injectable filler for correcting NLF.
透明质酸填充剂用于改善鼻唇沟（NLF）外观。本研究旨在比较一种新型透明质酸凝胶（润致妥）与瑞蓝在矫正鼻唇沟方面的疗效、安全性和持久性。这是一项多中心、双盲、随机、对照、非劣效性临床试验，纳入88例中重度鼻唇沟患者。患者被随机分为在鼻唇沟两侧分别注射润致妥和瑞蓝。在注射前、注射后即刻、1周、1个月、3个月和6个月时对鼻唇沟进行评估。对患者进行13 - 15个月的随访，以评估持久性和长期安全性。临床上有意义的反应预先定义为在皱纹严重程度评分量表（五分制量表）上至少提高1分。6个月时，润致妥的有效率不低于瑞蓝（P < 0.05）。在13 - 15个月的随访中，研究者评估的润致妥一侧有效率为58.0%，瑞蓝一侧为63.8%。受试者评估的结果相似，13 - 15个月时润致妥一侧为56.5%，瑞蓝一侧为60.9%。受试者的整体美学改善量表（GAIS）显示，在所有时间点，大多数受试者感觉鼻唇沟两侧均有改善（P > 0.05）。6个月时，100%的受试者报告两侧均有改善；13 - 15个月时，60%使用润致妥的受试者报告有改善，使用瑞蓝的受试者为64%。不良事件为短暂性，严重程度主要为轻度或中度，包括注射部位肿胀、疼痛、瘙痒、瘀斑和压痛。润致妥具有可靠的安全性和耐受性，可作为矫正鼻唇沟的有效注射填充剂。
