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一种凝聚性多致密化基质透明质酸用于矫正眶下凹陷的安全性和有效性:一项40周结果的观察性研究

Safety and efficacy of a cohesive polydensified matrix hyaluronic acid for the correction of infraorbital hollow: an observational study with results at 40 weeks.

作者信息

Hevia Oscar, Cohen Bernard H, Howell David J

出版信息

J Drugs Dermatol. 2014 Sep;13(9):1030-6.

PMID:25226002
Abstract

BACKGROUND

Utilizing a soft-tissue filler that is more fluid and less resistant to deformation may be advantageous for correction of infraorbital hollows.

OBJECTIVE

The objective of this study was to determine the safety and efficacy of the latest hyaluronic acid filler, created with a cohesive polydensified matrix, with a low elasticity and viscosity, for infraorbital hollows correction.

METHODS AND MATERIALS

Subjects (49) with at least a grade 2 Merz infraorbital hollow scale in the Validated Assessment Scales for the mid face (0-4) of the right and/or left side were photographed and treated at baseline, and with a touch up treatment after 2 weeks if necessary. Subjects were also photographed at 2, 6, and 10 months after baseline, with optional retreatment at 6 months. The photographs were graded by a blinded sub-investigator.

RESULTS

Mean hollowness scores for both eyes, either individually or combined, at 2, 6, and 10 months were considerably improved compared to baseline (P<.001). No serious adverse events were reported. Of the 46 subjects completing the study, 31 (66%) did not request retreatment after 6 months. At 10 months, 27/31 (87%) still exhibited a hollowness improvement of at least 1-point from baseline.

CONCLUSION

Belotero Balance was safe and effective for the correction of infraorbital hollows.

摘要

背景

使用流动性更强、抗变形能力更弱的软组织填充剂可能有利于矫正眶下凹陷。

目的

本研究的目的是确定最新的透明质酸填充剂(采用凝聚性多致密化基质制成,具有低弹性和低粘度)用于矫正眶下凹陷的安全性和有效性。

方法和材料

对49名受试者进行了研究,这些受试者在右侧和/或左侧面部中部验证评估量表(0 - 4)中至少有2级Merz眶下凹陷量表评分,在基线时进行拍照和治疗,如有必要,2周后进行补打治疗。在基线后的2、6和10个月也对受试者进行拍照,6个月时可选择再次治疗。照片由一名不知情的副研究员进行评分。

结果

与基线相比,在2、6和10个月时,单眼或双眼的平均凹陷评分均有显著改善(P <.001)。未报告严重不良事件。在完成研究的46名受试者中,31名(66%)在6个月后未要求再次治疗。在10个月时,27/31(87%)的受试者眶下凹陷程度仍比基线时至少改善了1分。

结论

Belotero Balance用于矫正眶下凹陷安全有效。

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