【 文献重点摘要 】

Background

Juvéderm Volbella with Lidocaine is a new hyaluronic acid dermal filler.

Methods

In this prospective, randomized, multicenter study, 280 subjects desiring lip volume enhancement were treated with Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated treatment outcomes on Allergan’s Lip Fullness Scale, Perioral Lines Scale, and Oral Commissures Severity Scale. A blinded independent central reviewer (ICR) assessed 3-dimensional digital photographs using these scales. Subjects evaluated outcomes using the FACEQ Recovery Early Life Impact and Recovery Early Symptoms modules. The primary endpoint was noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L based on responder rate (percentage of subjects with ≥1-point Lip Fullness Scale improvement at month 3 ICR assessment vs baseline).

Results

Juvéderm Volbella with Lidocaine was noninferior to Restylane-L. Although responder rates based on ICR assessments of lip fullness, perioral lines, and oral commissures did not differ between treatments, investigator assessments showed significant improvements in perioral lines and oral commissures with Juvéderm Volbella with Lidocaine vs Restylane-L (P ≤ 0.029). Subjects treated with Juvéderm Volbella with Lidocaine had higher mean FACE-Q scores on day 1 (P ≤ 0.001), indicating less disruption of daily activities. Mean change in lip volume from baseline to day 1 was smaller in the Juvéderm Volbella with Lidocaine group (but similar between treatments on day 14), indicating less acute swelling. Severe injection site responses occurred less frequently with Juvéderm Volbella with Lidocaine.

Conclusions

Juvéderm Volbella with Lidocaine is effective for lip enhancement, improves perioral lines and oral commissures, and results in less short-term swelling and disruption in daily activities than Restylane-L.

背景

Juvéderm Volbella联合利多卡因是一种新型透明质酸真皮填充剂。

方法

在这项前瞻性、随机、多中心的研究中，280名希望增加嘴唇容积的受试者接受Juvéderm Volbella联合利多卡因或Restylane-L的治疗。研究人员根据Allergan的嘴唇丰满度、口周线条和口腔连结严重程度对治疗结果进行评分。一位盲目的独立中央审查员(ICR)使用这些标尺评估了3维数码照片。受试者使用FACEQ康复早期生活影响和康复早期症状模块评估结果。主要终点是根据应答率(与基线相比，在第3个月≥1点唇充盈评分改善的受试者的百分比)，使用利多卡因的Juvéderm Volbella与Restylane-L不逊色。

结果

加有利多卡因的Juvéderm Volbella不亚于Restylane-L。虽然根据ICR对嘴唇饱满、口周线条和口腔连结的评估，不同治疗方法的应答率没有差异，但研究者的评估显示，使用利多卡因的Juvéderm Volbella与服用Restylane-L的相比，口周线条和口腔连结有显著改善(P≤0.029)。接受Juvéderm Volbella与利多卡因联合治疗的受试者在第1天的平均Face-Q评分较高(P≤0.001)，表明日常活动受到的干扰较少。在Juvéderm Volbella加利多卡因组，从基线到第1天，嘴唇体积的平均变化较小(但第14天两次治疗之间的变化相似)，表明急性肿胀较轻。使用Juvéderm Volbella和利多卡因注射部位严重反应的发生率较低。

结论

Juvéderm Volbella联合利多卡因具有良好的丰唇效果，能改善口周线条和口角，且短期肿胀和日常活动障碍比Restylane-L小。