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两种透明质酸衍生物(瑞蓝·雅致和乔雅登)治疗鼻唇沟疗效的随机双盲比较

Randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, restylane perlane and hylaform, in the treatment of nasolabial folds.

作者信息

Carruthers Alastair, Carey Wayne, De Lorenzi Claudio, Remington Kent, Schachter Daniel, Sapra Sheetal

机构信息

Division of Dermatology, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Dermatol Surg. 2005 Nov;31(11 Pt 2):1591-8; discussion 1598. doi: 10.2310/6350.2005.31246.

DOI:10.2310/6350.2005.31246
PMID:16416643
Abstract

BACKGROUND

Cross-linked hyaluronic acid gels may offer longer-lasting cosmetic correction and a lower risk of immunogenicity than other soft tissue augmentation agents.

OBJECTIVE

To compare the efficacy and safety of a non-animal-stabilized hyaluronic acid gel (Restylane Perlane, Q-Med, Uppsala, Sweden) with that of a hylan B gel (Hylaform, Genzyme Corp., Cambridge, MA, USA), a cross-linked hyaluronic acid from chicken combs, for treatment of nasolabial folds.

METHODS

One hundred fifty patients with moderate or severe nasolabial folds were randomized to contralateral treatment with Restylane Perlane and Hylaform. Efficacy was assessed using semi-objective outcome instruments at 3, 4.5, and 6 months after achievement of an "optimal cosmetic result". Patients subsequently underwent open-label bilateral retreatment with Restylane Perlane (if required) and were followed up for a further 6 months.

RESULTS

The two products were equally effective in producing an optimal cosmetic result, although fewer treatment sessions were required with Restylane Perlane. At 6 months post-treatment, a higher proportion of patients showed a > or = 1-grade improvement in Wrinkle Severity Rating Scale (WSRS) score with Restylane Perlane (75%) than with Hylaform (38%). Restylane Perlane was considered superior in 64% of patients, whereas Hylaform was superior in 8% of patients. Treatment-related adverse events tended to be more frequent with Restylane Perlane. Local injection-site reactions were generally transient and mild or moderate in intensity and were no more frequent after Restylane Perlane retreatment.

CONCLUSIONS

Restylane Perlane provides a more durable esthetic improvement than Hylaform and offers acceptable tolerability.

摘要

背景

与其他软组织填充剂相比,交联透明质酸凝胶可能提供更持久的美容矫正效果,且免疫原性风险更低。

目的

比较非动物稳定透明质酸凝胶(瑞蓝·丽瑅,Q-Med公司,瑞典乌普萨拉)与鸡冠来源的交联透明质酸凝胶(海魅,健赞公司,美国马萨诸塞州剑桥)治疗鼻唇沟的疗效和安全性。

方法

150例中重度鼻唇沟患者被随机分为两组,分别接受瑞蓝·丽瑅和海魅的对侧治疗。在达到“最佳美容效果”后的3个月、4.5个月和6个月,使用半客观结果评估工具评估疗效。随后,患者接受瑞蓝·丽瑅的开放标签双侧再次治疗(如有需要),并随访6个月。

结果

两种产品在产生最佳美容效果方面同样有效,尽管瑞蓝·丽瑅所需的治疗次数较少。治疗后6个月,与海魅(38%)相比,接受瑞蓝·丽瑅治疗的患者中有更高比例(75%)的患者在皱纹严重程度评分量表(WSRS)上显示改善≥1级。64%的患者认为瑞蓝·丽瑅更优,而8%的患者认为海魅更优。与治疗相关的不良事件在瑞蓝·丽瑅治疗中往往更频繁。局部注射部位反应通常是短暂的,强度为轻度或中度,在瑞蓝·丽瑅再次治疗后并不更频繁。

结论

瑞蓝·丽瑅比海魅提供更持久的美学改善,且耐受性可接受。

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