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前瞻性体内评估三种不同透明质酸凝胶与不同剂量透明质酸酶的长期随访。

Prospective in vivo evaluation of three different hyaluronic acid gels to varying doses of hyaluronidase with long-term follow-up.

机构信息

USC Roski Eye Institute, Keck School of Medicine, Los Angeles 90033, CA, United States.

USC Roski Eye Institute, Keck School of Medicine, Los Angeles 90033, CA, United States.

出版信息

J Plast Reconstr Aesthet Surg. 2021 Apr;74(4):874-880. doi: 10.1016/j.bjps.2020.10.052. Epub 2020 Nov 6.

Abstract

PURPOSE

Several injectable hyaluronic acid dermal fillers exist in the market, each with different rheologic and cross-linking properties. Their reversibility is useful for managing complications. We sought to determine the response of three different hyaluronic acid gels to varying doses of hyaluronidase.

METHODS

Each of 18 arms of nine subjects were prospectively randomized to receive intradermal injections of hyaluronic acid gel (Restylane-L, Juvéderm Ultra, Juvéderm Voluma). Seven sites on each arm were randomized to receive 0.2 mL of hyaluronic acid gel in anticipation of dissolution 1 week later with varying doses of hyaluronidase (Hylenex), 2.5, 5, 10, or 20 units or to be a control site. The outcome measures of diameter, elevation, and firmness were measured pre-injection and at varying time points to beyond 4 years. Subjects, graders, and injectors were masked.

RESULTS

The most dramatic changes for all fillers occurred starting at the 30-min time point through 3 h time point, with continued gradual degradation through week 2. A mild dose response was found for Juvéderm and Restylane; however, a clear dose response was seen from 2.5 to 10 units for Voluma, with 2.5 units showing features more like those of saline only or no hyaluronidase control. One Restylane arm had controls lasting four years.

CONCLUSIONS

All fillers had a dose response, with Voluma exhibiting it most clearly. Voluma required higher doses of hyaluronidase for dissolution, i.e., more than 20 units per 0.2 mL of filler. Restylane appeared to respond most readily to hyaluronidase, at the dose of even 2.5 units, but it also was fastest to dissolve on its own.

摘要

目的

市场上存在多种注射用透明质酸真皮填充剂,每种填充剂的流变学和交联特性均不同。它们的可逆性有助于处理并发症。我们旨在确定三种不同透明质酸凝胶对不同透明质酸酶剂量的反应。

方法

9 名受试者的 18 个部位的每一个部位均前瞻性随机接受透明质酸凝胶(瑞蓝 2 型、乔雅登 Ultra、乔雅登 Voluma)皮内注射。每只手臂的 7 个部位随机接受 0.2ml 透明质酸凝胶,预计 1 周后用不同剂量透明质酸酶(海薇)2.5、5、10 或 20 单位溶解或作为对照部位。在注射前以及在不同时间点测量直径、隆起度和硬度作为结局测量指标,时间点超过 4 年。受试者、评估者和注射者均设盲。

结果

所有填充物最明显的变化发生在 30 分钟至 3 小时的时间点,在第 2 周时继续逐渐降解。乔雅登和瑞蓝呈现轻度剂量反应;然而,Voluma 则呈现明显的剂量反应,从 2.5 至 10 单位,2.5 单位的表现更类似于仅盐水或无透明质酸酶对照。1 个瑞蓝部位的对照持续了 4 年。

结论

所有填充物均呈现剂量反应,Voluma 最明显。溶解 Voluma 需要更高剂量的透明质酸酶,即每 0.2ml 填充物需要超过 20 单位的透明质酸酶。瑞蓝似乎对透明质酸酶反应最迅速,即使剂量为 2.5 单位,但它也最快自行溶解。

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