冷冻溶脂对健康女性和患者满意度的下腹部脂肪厚度的影响：一项随机对照试验。
Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial.
机构信息
Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.
Department of Basic Health Sciences, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.
出版信息
Braz J Phys Ther. 2020 Sep-Oct;24(5):441-448. doi: 10.1016/j.bjpt.2019.07.005. Epub 2019 Jul 26.
OBJECTIVE
To analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of healthy women and patient's satisfaction.
METHODS
Design and setting: a randomized controlled trial, with concealed allocation and blinded assessor.
PARTICIPANTS
34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥3cm, BMI between 18.5 and 27kg/m, low level of physical activity, and no contraindication to cryolipolysis were allocated to intervention group (IG, n=17) or control group (CG, n=17).
INTERVENTIONS
The IG received one session of cryolipolysis with -10°C of temperature for 50min. The CG was not submitted to any kind of intervention. Both groups did the evaluation protocols at baseline, 30, 60 and 90 days after the intervention.
MAIN OUTCOME MEASURES
fat thickness was measured by ultrasonography (US), skinfold (SF) and abdominal circumference (AC1 and AC2).
RESULTS
No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05cm (95%CI: -0.12; 0.22), 60 days: 0.05cm (95%CI: -0.11; 0.20) and 90 days: 0.04cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09cm (95%CI: -0.25; 0.08), 60 days: -0.14cm (95%CI: -0.36; 0.09) and 90 days: -0.001cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42cm (95%CI: -1.1; 1.9), 60 days: -0.1cm (95%CI: -1.74; 1.54) and 90 days: -0.007cm (-1.9; 1.9)) and AC2 (30 days: 0.183cm (95%CI: -0.84; 1.20), 60 days: -0.13cm (95%CI: -1.61; 1.35) and 90 days: -0.31cm (95%CI: -1.61; 1.00)).
CONCLUSIONS
The current study showed that a single application of the utilized protocol of cryolipolysis does not produce any significant effect on fat thickness of the lower abdomen of healthy women.
CLINICAL TRIAL REGISTRATION NUMBER
NCT03160976 (https://clinicaltrials.gov/ct2/show/NCT03160976). Contribution of the Paper: the study is one of the first studies in the literature with methodological rigor to report an unfavorable result for localized abdominal fat treatment with a single session of cryolipolysis.
目的
分析冷冻溶脂对健康女性下腹脂肪厚度的影响及患者满意度。
方法
设计和设置：一项随机对照试验，采用隐藏分组和盲法评估。
参与者
34 名 18 至 48 岁的健康女性，下腹皮褶厚度≥3cm，BMI 为 18.5 至 27kg/m，低水平体力活动，无冷冻溶脂禁忌证，被分为干预组（IG，n=17）或对照组（CG，n=17）。
干预措施
IG 接受一次 -10°C 的冷冻溶脂治疗，持续 50min。CG 未接受任何干预。两组均在干预前、30、60 和 90 天进行评估方案。
主要观察指标
脂肪厚度通过超声（US）、皮褶（SF）和腹围（AC1 和 AC2）测量。
结果
在任何随访时间点，IG 和 CG 在 US（30 天：0.05cm（95%CI：-0.12；0.22）、60 天：0.05cm（95%CI：-0.11；0.20）和 90 天：0.04cm（95%CI：-0.7；0.25））、SF（30 天：-0.09cm（95%CI：-0.25；0.08）、60 天：-0.14cm（95%CI：-0.36；0.09）和 90 天：-0.001cm（95%CI：-0.237；0.234））、AC1（30 天：0.42cm（95%CI：-1.1；1.9）、60 天：-0.1cm（95%CI：-1.74；1.54）和 90 天：-0.007cm（-1.9；1.9））和 AC2（30 天：0.183cm（95%CI：-0.84；1.20）、60 天：-0.13cm（95%CI：-1.61；1.35）和 90 天：-0.31cm（95%CI：-1.61；1.00））方面均无显著差异。
结论
本研究表明，单次应用所使用的冷冻溶脂方案对健康女性下腹脂肪厚度没有显著影响。
临床试验注册号
NCT03160976（https://clinicaltrials.gov/ct2/show/NCT03160976）。
本文贡献
该研究是文献中首批采用严格方法报告单次冷冻溶脂治疗局部腹部脂肪不利结果的研究之一。
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