【 文献重点摘要 】

Background

YVOIRE Classic s (YC) and Restylane (RES) have similar rheological properties, which suit mid-dermis injection, while the rheological properties of YVOIRE Volume s (YV) are comparable to those of Perlane (PER), which suit deep dermis injection to treat deep wrinkles. Two similarly designed studies aimed to evaluate the performance and safety of YC and YV injected into the nasolabial folds (NLFs).

Methods

These were split-face designed, evaluator-blind, noninferiority studies. Fifty-eight subjects with moderate-to-severe NLFs were enrolled in the first study and treated with YC and RES, and 57 subjects were enrolled in the second study and treated with YV and PER. The Wrinkle Severity Rating Scale ranged from 1 (no visible fold) to 5 (extremely deep and long folds), and subject satisfaction was evaluated.

Results

The least squares mean Wrinkle Severity Rating Scale scores (standard error) at week 26 were 2.56 (0.09) for both YC- and RES-treated NLFs and 2.89 (0.08) and 2.91 (0.08) for YV- and PER-treated NLFs, respectively. The difference between the groups was 0 and 0.02, and the lower limit of its 95% confidence interval was −0.0725 and −0.0125, which was greater than the predefined margin (−0.29), proving the noninferiority of YC and YV to RES and PER, respectively. The safety profiles and subject satisfaction of YC and YV were similar to those of RES and PER, respectively.

Conclusion

YC is comparable to RES and YV is comparable to PER in terms of performance and safety profiles, with NLF-correcting effects lasting for up to 26 weeks.

背景

YVOIRE Classic s(YC)和Restylane(RES)具有相似的流变特性，适合真皮中部注射，而YV的流变特性与Perane(PER)相当，适合真皮深层注射治疗深部皱纹。两项类似设计的研究旨在评估YC和YV注射到鼻唇沟(NLF)的效果和安全性。

方法

采用双面设计、评价者盲法、非劣势研究。58名中重度NLFS患者参加了第一项研究，用YC和RES治疗；57名受试者参加了第二项研究，接受YV和PER治疗。皱纹严重程度评分从1(无明显皱褶)到5(极深和极长皱褶)，并对受试者的满意度进行评估。

结果

在26周时，YC和RES治疗的NLFs的皱纹严重程度评定量表评分(标准误差)的最小二乘分别为2.56(0.09)和2.89(0.08)，YV和PER治疗的NLFs的最小二乘平均得分(标准误差)分别为2.91(0.08)和2.89(0.08)。两组间的差值为0.0725和0.02，其95%可信区间下限分别为−0.0725和−0.0125，均大于预定义的边际(−0.29)，证明了YC和YV对RES和PER的非劣势。YC和YV的安全性和受试者满意度分别与RE和PER相似。

结论

YC在性能和安全性方面与RES相当，YV与PER相当，纠正NLF的效果长达26周。