Instituto Médico Miramar, P. Miramar, 21, 29016, Malaga, Spain.
Aesthetic Plast Surg. 2022 Oct;46(5):2438-2449. doi: 10.1007/s00266-022-02919-2. Epub 2022 Jun 1.
To assess the efficacy and safety of a new non-invasive body contouring device in patients with localized fat in abdomen or in abdomen and hips. Additionally, we also evaluated the patient satisfaction with the procedure.
Prospective and non-randomized open label study. The patients underwent four sessions, separated by 1 week each, with the Alma PrimeX, a non-invasive body contouring device that combines pulsed non-focus ultrasound and a Unipolar radiofrequency. The primary end point was the mean change in fat tissue thickness, assessed by diagnostic ultrasound, from baseline to 3-months after the last treatment-session.
Fifteen subjects were evaluated. As compared to pre-treatment thickness, Hodges-Lehmann median difference (95% CI) was - 85.3 (- 107.5 to - 62.0) mm, p = 0.0001; - 70.3 (- 95.0 to - 48.5) mm, p = 0.0001; - 100.0 (- 140.5 to - 49.5) mm, p = 0.0039; and - 71.8 (- 132.5 to - 23.0) mm, p = 0.0078 in infraumbilical, supraumbilical, right hip, and left hip, respectively. Pretreatment fat volume was significantly reduced from 32.9% to 31.2%, p = 0.0006. The median (interquartile range) degree of patient satisfaction was 4.0 (1.0-5.0), with 13 (86.7%) patients being "Highly satisfied" or "Satisfied" with the treatment results. The most common adverse event was discomfort, followed by erythema. All the adverse events were mild and were successfully resolved without treatment.
Combine therapy of a Pulsed non-focus ultrasound and Unipolar radiofrequency using the non-invasive device Alma PrimeX was an effective and safe treatment for reducing fat tissue thickness in abdomen and hips in patients with localized fat. Patients' satisfaction with the procedure was high.
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
评估一种新型非侵入性身体塑形设备在腹部或腹部和臀部局部脂肪患者中的疗效和安全性。此外，我们还评估了患者对该手术的满意度。
前瞻性、非随机、开放标签研究。患者接受了四次治疗，每次治疗间隔 1 周，使用 Alma PrimeX 非侵入性身体塑形设备，该设备结合了脉冲非聚焦超声和单极射频。主要终点是治疗结束后 3 个月时通过诊断超声评估的脂肪组织厚度的平均变化。
15 名受试者接受了评估。与治疗前厚度相比，Hodges-Lehmann 中位数差值（95%CI）为-85.3（-107.5 至-62.0）mm，p=0.0001；-70.3（-95.0 至-48.5）mm，p=0.0001；-100.0（-140.5 至-49.5）mm，p=0.0039；-71.8（-132.5 至-23.0）mm，p=0.0078，分别位于脐下、脐上、右髋和左髋。治疗前脂肪体积从 32.9%显著减少至 31.2%，p=0.0006。中位数（四分位距）患者满意度为 4.0（1.0-5.0），13 名（86.7%）患者对治疗结果表示“非常满意”或“满意”。最常见的不良事件是不适，其次是红斑。所有的不良事件都是轻微的，无需治疗即可自行解决。
使用非侵入性 Alma PrimeX 设备联合应用脉冲非聚焦超声和单极射频的联合治疗是一种有效且安全的治疗方法，可减少腹部和臀部局部脂肪患者的脂肪组织厚度。患者对该手术的满意度很高。
证据水平 IV：本杂志要求作者为每篇文章分配一个证据水平。有关这些循证医学评级的完整描述，请参考目录或在线作者指南www.springer.com/00266。
