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比较两种不同快速声波脉冲率的声能辅助下的皮下分离术改善皮肤橘皮样外观的安全性和有效性。

Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite.

机构信息

Department of Ophthalmology, Dermatology, and Otolaryngology, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.

Allergan Aesthetics, an AbbVie Company, Irvine, California, USA.

出版信息

Lasers Surg Med. 2024 Jan;56(1):32-38. doi: 10.1002/lsm.23718. Epub 2023 Sep 11.

DOI:10.1002/lsm.23718
PMID:37694399
Abstract

BACKGROUND

A recent study showed the safety and efficacy of a noninvasive acoustic subcision device to improve the appearance of cellulite via delivery of rapid acoustic pulses in a single treatment visit.

OBJECTIVE

To evaluate and compare the safety and efficacy of a single rapid acoustic pulse treatment visit using an equivalent number of rapid acoustic pulses at a pulse rate of 100 or 50 Hz.

METHODS

This single-center, prospective study enrolled 15 adult women with moderate to severe cellulite according to the Cellulite Dimple-At Rest Scale. Each participant would receive nominally 72,000 rapid acoustic pulses at a pulse rate of 50 Hz on the left buttock and thigh, and nominally 72,000 rapid acoustic pulses at a pulse rate of 100 Hz on the right buttock and thigh within one treatment visit. Efficacy was assessed by the ability of blinded, independent reviewers to correctly distinguish the pre- and post-treatment photos, participant satisfaction, and the change in Cellulite Dimple-At Rest scores for each treatment side. Safety was monitored throughout the conduct of the study.

RESULTS

For both 100 and 50 Hz pulse rate treated areas, the majority (two out of three) of blinded reviewers correctly identified 100% of the pre/post-treatment photos. For both the 100 and 50 Hz treated areas, 80% of participants agreed/strongly agreed that their cellulite appeared improved at the 12-week follow-up visit. Significant improvements in Cellulite Dimple-At Rest scores were seen for both the 100 and 50 Hz treated areas. All participants thought both the 100 and 50 Hz pulse rate treatments were tolerable, and the pain (mean score ± SD; 2.2 ± 1.2) associated with each was identical. No unexpected or serious adverse events occurred.

CONCLUSION

Acoustic subcision delivered via rapid acoustic pulses at 100 Hz, compared to 50 Hz, provides equivalent improvement in the appearance of cellulite while maintaining a similar safety and efficacy profile. For both pulse rates, treatment pain was minimal, and participant satisfaction was high.

摘要

背景

最近的一项研究表明,非侵入性声波亚穿刺设备通过单次治疗中快速声波脉冲的输送,具有改善皮肤橘皮样外观的安全性和有效性。

目的

评估和比较以 100Hz 或 50Hz 的脉冲率输送相同数量快速声波脉冲单次快速声波脉冲治疗的安全性和有效性。

方法

这项单中心前瞻性研究纳入了根据 Cellulite Dimple-At Rest Scale 评估为中度至重度皮肤橘皮样的 15 名成年女性。每位参与者的左侧臀部和大腿将接受名义上 72,000 个 50Hz 脉冲率的快速声波脉冲,右侧臀部和大腿将接受名义上 72,000 个 100Hz 脉冲率的快速声波脉冲,均在单次治疗中完成。通过盲法、独立评估者正确区分治疗前后照片的能力、参与者满意度以及每个治疗侧的 Cellulite Dimple-At Rest 评分的变化来评估疗效。在整个研究过程中监测安全性。

结果

对于 100Hz 和 50Hz 脉冲率治疗区域,三分之二(两例)的盲法评估者正确识别了 100%的治疗前后照片。对于 100Hz 和 50Hz 治疗区域,80%的参与者在 12 周随访时同意/强烈同意他们的皮肤橘皮样外观有所改善。Cellulite Dimple-At Rest 评分在 100Hz 和 50Hz 治疗区域均显著改善。所有参与者均认为 100Hz 和 50Hz 脉冲率治疗均可耐受,且与两种治疗相关的疼痛(平均评分±标准差;2.2±1.2)相同。未发生意外或严重不良事件。

结论

与 50Hz 相比,以 100Hz 输送的声波亚穿刺在保持相似的安全性和疗效特征的同时,可提供皮肤橘皮样外观的等效改善。对于两种脉冲率,治疗疼痛轻微,参与者满意度高。

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