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随机、安慰剂对照、分颈试验,评估使用注射器或针头的透明质酸填充剂对静态水平颈部皱纹的效果。

A Randomized, Placebo-Controlled, Split-Neck Trial of Hyaluronic Acid Filler for Static Horizontal Neck Rhytides Using Either a Cannula or Needle.

机构信息

Department of Dermatology, University of Miami, Miami, Florida.

Siperstein Dermatology Group, Boynton Beach, Florida.

出版信息

Dermatol Surg. 2022 Apr 1;48(4):423-428. doi: 10.1097/DSS.0000000000003391.

Abstract

BACKGROUND

Hyaluronic acid (HA) fillers have been studied extensively on the face; however, their safety and efficacy on the neck has not yet been evaluated in a prospective trial in the United States.

OBJECTIVE

Analyze the efficacy and safety of a HA filler for static horizontal neck rhytides using either a cannula or needle.

MATERIALS AND METHODS

Twenty-six subjects were randomized to receive up to 1 mL of the HA filler Restylane Refyne (HARR, n = 20) or saline (n = 6) using a cannula on one side and a needle on the other with optional repeat treatment. Subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale.

RESULTS

A significant improvement 30 days after the last treatment was achieved on the Transverse Neck Line Scale when comparing HARR with saline according to the blind evaluator, subjects, and investigator without any significant side effects. In addition, the blind evaluator, subjects, and investigator rated the side of the neck injected with a needle as having significantly greater improvement than the cannula.

CONCLUSION

The hyaluronic acid filler, Restylane Refyne, achieved significant improvement in static horizontal neck rhytides using either a cannula or needle without any serious side effects, although the needle was more effective.

摘要

背景

透明质酸(HA)填充剂已在面部得到广泛研究;然而,它们在颈部的安全性和有效性尚未在美国的前瞻性试验中进行评估。

目的

分析一种 HA 填充剂(Restylane Refyne,HARR)用于治疗静态水平颈部皱纹的疗效和安全性,该填充剂可通过套管或针进行注射。

材料和方法

26 名受试者随机接受一侧套管注射 HARR(n = 20)或生理盐水(n = 6),另一侧针注射 HARR 或生理盐水(n = 6),并可选择重复治疗。使用横向颈部线量表、Canfield 摄影和全球美学改善量表对受试者进行分级。

结果

最后一次治疗后 30 天,根据盲法评估者、受试者和研究者的评估,HARR 与生理盐水相比,横向颈部线量表的评分显著改善,且无明显不良反应。此外,盲法评估者、受试者和研究者均认为针注射侧的颈部改善程度明显大于套管注射侧。

结论

透明质酸填充剂 Restylane Refyne 通过套管或针注射治疗静态水平颈部皱纹,均具有显著的改善效果,且无严重不良反应,尽管针注射效果更明显。

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