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首页> 外文期刊>Clinical, Cosmetic and Investigational Dermatology >Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study
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Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study

机译：透明质酸填充剂在治疗中脸体积不足的患者中的疗效和安全性：24个月研究

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Background: Hyaluronic acid (HA) fillers are an established intervention for correcting facial volume deficiency. Few studies have evaluated treatment outcomes for longer than 6 months. The purpose of this study was to determine the durability of an HA filler in the correction of midface volume deficiency over 24 months, as independently evaluated by physician investigators and subjects.Methods: Subjects received treatment with Juvéderm? Voluma? to the malar area, based on the investigators' determination of baseline severity and aesthetic goals. The treatment was administered in one or two sessions over an initial 4-week period. Supplementary treatment was permissible at week 78, based on protocol-defined criteria. A clinically meaningful response was predefined as at least a one-point improvement on the MidFace Volume Deficit Scale (MFVDS) and on the Global Aesthetic Improvement Scale (GAIS).Results: Of the 103 subjects enrolled, 84% had moderate or significant volume deficiency at baseline. At the first post-treatment evaluation (week 8), 96% were documented to be MFVDS responders, with 98% and 100% graded as GAIS responders when assessed by the subjects and investigators, respectively. At week 78, 81.7% of subjects were still MFVDS responders, with 73.2% and 78.1% being GAIS responders, respectively. Seventy-two subjects completed the 24-month study, of whom 45 did not receive supplementary Voluma? at week 78. Forty-three of the 45 (95.6%) subjects were MFVDS responders, with 82.2% and 91.1% being GAIS responders, respectively. At end of the study, 66/72 subjects were either satisfied or very satisfied with Voluma?, with 70/72 indicating that they would recommend the product to others. Adverse events were transient and infrequent, with injection site bruising and swelling being the most commonly reported.Conclusion: Voluma? is safe and effective in the correction of mild to severe facial volume deficiency, achieving long-term clinically meaningful results. There was a high degree of satisfaction with the treatment outcome over the 24 months of the study.
机译：背景：透明质酸（HA）填充剂是纠正面部体积不足的公认干预措施。很少有研究评估治疗结果超过6个月以上。这项研究的目的是确定在24个月内纠正脸部容积不足的HA填充剂的持久性，这是由医学研究者和受试者独立评估的。方法：受试者接受了Juvéderm？ uma根据研究人员对基线严重程度和美学目标的确定，确定是否进入黄斑区域。在最初的4周内分一两次进行治疗。根据方案定义的标准，在第78周允许进行补充治疗。临床上有意义的反应被定义为在中脸面部表情缺损量表（MFVDS）和整体美学改善量表（GAIS）上至少获得单点改善。结果：在登记的103位受试者中，有84％的患者出现中度或严重的体力不足在基线。在首次治疗后评估（第8周）中，有96％的患者为MFVDS应答者，经受试者和研究者评估时分别为98％和100％为GAIS应答者。在第78周时，仍有81.7％的受试者仍然是MFVDS应答者，分别为73.2％和78.1％是GAIS应答者。 72位受试者完成了为期24个月的研究，其中45位没有接受补充的Voluma？在第78周时。45名受试者（43.6％）中有43名是MFVDS应答者，分别是82.2％和91.1％是GAIS应答者。在研究结束时，66/72名受试者对Voluma？感到满意或非常满意，其中70/72表明他们会向其他人推荐该产品。不良事件是短暂且不常见的，最常报告注射部位有瘀伤和肿胀。安全有效地纠正轻度至重度面部体积不足，并取得长期的临床意义。在研究的24个月中，患者对治疗结果的满意度很高。

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