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使用双探头冷冻溶脂系统进行多次同时冷冻溶脂治疗的安全性、有效性及参与者满意度

Safety, Effectiveness, and Participant Satisfaction With Multiple Simultaneous Cryolipolysis Treatments Using a Dual-Applicator Cryolipolysis System.

作者信息

Bachelor Eric, Moradi Amir, Stevens Grant, Scott-Shemon Deja, Ostrowski Rafael, Madere Tonia, Gamio Sylvia

机构信息

Eastbay Aesthetic Surgery, Pleasanton, California.

Moradi M.D. Cosmetic Surgery, Vista, California.

出版信息

Dermatol Surg. 2025 Feb 11;51(6):604-610. doi: 10.1097/DSS.0000000000004574.

DOI:10.1097/DSS.0000000000004574
PMID:39933071
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12118610/
Abstract

BACKGROUND

Cryolipolysis is a safe, effective, and noninvasive treatment for subcutaneous fat reduction.

OBJECTIVE

Assess safety, effectiveness, and participant satisfaction with multiple simultaneous dual-applicator cryolipolysis treatments on the torso.

MATERIALS AND METHODS

Adult participants received multiple simultaneous treatments to the torso (i.e., flanks, abdomen, back/bra area). Primary effectiveness end point was ≥70% correct identification of baseline versus week 12 post-final treatment photographs by ≥2 of 3 independent reviewers; safety end point was frequency of adverse device effects (ADEs). Secondary end points included fat layer thickness reduction and participant satisfaction/comfort.

RESULTS

Mean participant age ( N = 35) was 40.4 years, 77.1% were female, and mean body mass index was 24.9 kg/m 2 . A mean of 20.8 treatment cycles were received over 2 treatment sessions. The primary effectiveness end point was met; 75% of pretreatment images were correctly identified. Mean reduction in fat layer thickness was 0.33 cm. Most ADEs were mild, with no serious events. Mean overall participant satisfaction with the procedure was 82.8%. Mean maximum pain scores were 2.6 and 4.1 (scale of 10) during treatment sessions 1 and 2, respectively.

CONCLUSION

Multiple simultaneous cryolipolysis treatments on the torso using a dual-applicator system were safe and effective, with high overall participant satisfaction.

摘要

背景

冷冻溶脂术是一种安全、有效且无创的皮下脂肪减少治疗方法。

目的

评估在躯干上同时进行多次双探头冷冻溶脂治疗的安全性、有效性及参与者满意度。

材料与方法

成年参与者接受了对躯干(即侧腹、腹部、背部/胸罩区域)的多次同时治疗。主要有效性终点是由3名独立评审员中的至少2名正确识别出基线照片与最终治疗后第12周照片的比例≥70%;安全性终点是不良器械效应(ADEs)的发生频率。次要终点包括脂肪层厚度减少以及参与者满意度/舒适度。

结果

参与者平均年龄(N = 35)为40.4岁,77.1%为女性,平均体重指数为24.9 kg/m²。在2个治疗疗程中平均接受了20.8个治疗周期。达到了主要有效性终点;75%的治疗前图像被正确识别。脂肪层厚度平均减少0.33 cm。大多数ADEs为轻度,无严重事件。参与者对该程序的总体平均满意度为82.8%。在第1和第2个治疗疗程中,平均最大疼痛评分分别为2.6和4.1(满分10分)。

结论

使用双探头系统在躯干上同时进行多次冷冻溶脂治疗是安全有效的,参与者总体满意度较高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d05/12118610/fc1c0859d4e9/ds-51-604-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d05/12118610/d7235cff7f9a/ds-51-604-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d05/12118610/fc1c0859d4e9/ds-51-604-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d05/12118610/d7235cff7f9a/ds-51-604-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d05/12118610/9ce1b32024c5/ds-51-604-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d05/12118610/ddbda4a3442b/ds-51-604-g003.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d05/12118610/fc1c0859d4e9/ds-51-604-g005.jpg

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Aesthet Surg J Open Forum. 2023 Nov 29;5:ojad103. doi: 10.1093/asjof/ojad103. eCollection 2023.
2
Cryolipolysis in the United States-Review of the clinical data.美国的冷冻溶脂技术——临床数据回顾。
J Cosmet Dermatol. 2023 Nov;22 Suppl 3:8-14. doi: 10.1111/jocd.16029.
3
Patient Satisfaction, Recommendation Rate, and Patient Comfort With an FDA-Cleared Cryolipolysis System.
使用经美国食品药品监督管理局(FDA)批准的冷冻溶脂系统时的患者满意度、推荐率及患者舒适度
Aesthet Surg J Open Forum. 2022 Aug 12;4:ojac067. doi: 10.1093/asjof/ojac067. eCollection 2022.
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High Participant Satisfaction Achieved Using Cryolipolysis for Fat Reduction of the Abdomen and Flanks.采用冷冻溶脂技术减少腹部和侧腰部脂肪,患者满意度高。
Aesthet Surg J. 2022 Jun 20;42(7):760-770. doi: 10.1093/asj/sjab421.
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Significant improvement in body contour with multiple cycles of CoolSculpting: Results of a prospective study.多次冷冻减脂治疗后身体轮廓有显著改善:一项前瞻性研究结果。
Dermatol Ther. 2021 Mar;34(2):e14850. doi: 10.1111/dth.14850. Epub 2021 Feb 21.
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