Abstract：
OBJECTIVE: With the growing demand for more effective fat reduction techniques, a combination of synchronized radiofrequency (RF) and HIFEM has been introduced. Preceding studies evidenced the ability of RF+HIFEM to maintain the fat tissue temperature at the levels necessary for adipocyte apoptosis while documenting the induced changes to the fat tissue during the several weeks after the treatment. This study aims to demonstrate the induction of apoptosis by RF+HIFEM technology in the early stages through the assessment of caspase-3 protein, one of the apoptosis-executing proteases.
METHODS: In this two-arm, single-center, randomized trial, nine human subjects were enrolled and assigned into two groups, either the active group (N = 6) treated with both RF+HIFEM set at the highest tolerated levels or the sham group (N = 3) treated with 5% of the maximum RF+HIFEM power, serving as a control. All patients were scheduled to undergo one treatment visit of the abdominal area, two follow-up visits at 8 and 24 h, and one safety visit 7 days after the treatment. A punch biopsy (5 mm in diameter, approximately 10 mm in depth) was obtained from the abdominal area at the baseline and consecutive follow-up visits. Samples were fixed, and cut into 5 μm thick slices, and immunohistochemical staining was used to visualize the Caspase-3, revealing the adipocyte nuclei where apoptosis processes are in progress.
RESULTS: Documented findings suggest that the temperature threshold of 43-45°C is required to initiate fat apoptosis and consequent reduction in adipocyte number was achieved during the combined treatment with RF+HIFEM. The active group showed an elevated ratio of positively stained nuclei versus all adipocyte nuclei found on the evaluated slices-referred to as the apoptotic index (AI). The AI significantly (p < 0.001) increased at both 8 h (47.01 ± 10.56%) and 24 h (43.58 ± 6.35%) posttreatment. The Sham group showed no significant change in the AI (p > 0.05). No adverse events or side effects related to the treatments were observed.
CONCLUSIONS: This study supports previously published evidence on fat reduction after RF+HIFEM treatment, documenting the safe initiation of adipocyte programmed cell death posttreatment.
METHODS: In this two-arm, single-center, randomized trial, nine human subjects were enrolled and assigned into two groups, either the active group (N = 6) treated with both RF+HIFEM set at the highest tolerated levels or the sham group (N = 3) treated with 5% of the maximum RF+HIFEM power, serving as a control. All patients were scheduled to undergo one treatment visit of the abdominal area, two follow-up visits at 8 and 24 h, and one safety visit 7 days after the treatment. A punch biopsy (5 mm in diameter, approximately 10 mm in depth) was obtained from the abdominal area at the baseline and consecutive follow-up visits. Samples were fixed, and cut into 5 μm thick slices, and immunohistochemical staining was used to visualize the Caspase-3, revealing the adipocyte nuclei where apoptosis processes are in progress.
RESULTS: Documented findings suggest that the temperature threshold of 43-45°C is required to initiate fat apoptosis and consequent reduction in adipocyte number was achieved during the combined treatment with RF+HIFEM. The active group showed an elevated ratio of positively stained nuclei versus all adipocyte nuclei found on the evaluated slices-referred to as the apoptotic index (AI). The AI significantly (p < 0.001) increased at both 8 h (47.01 ± 10.56%) and 24 h (43.58 ± 6.35%) posttreatment. The Sham group showed no significant change in the AI (p > 0.05). No adverse events or side effects related to the treatments were observed.
CONCLUSIONS: This study supports previously published evidence on fat reduction after RF+HIFEM treatment, documenting the safe initiation of adipocyte programmed cell death posttreatment.
摘要：
目标：随着对更有效的减脂技术的需求不断增长，已引入同步射频（RF）和HIFEM的组合。先前的研究证明了RF+HIFEM将脂肪组织温度维持在脂肪细胞凋亡所必需的水平的能力,同时记录了在治疗后几周对脂肪组织的诱导变化。本研究旨在通过对caspase-3蛋白的评估，证明RF+HIFEM技术在早期诱导细胞凋亡。执行细胞凋亡的蛋白酶之一。
方法：在这个双臂中，单中心,随机试验,九名人类受试者被登记并分为两组，用RF+HIFEM处理的活动组(N=6)设定在最高耐受水平,或者用最大RF+HIFEM功率的5%处理的假手术组(N=3),作为一个控制。所有患者均计划进行一次腹部治疗，8小时和24小时两次随访，治疗后7天进行一次安全访视。穿刺活检（直径5毫米，在基线和连续随访时，从腹部区域获得约10mm的深度）。样品是固定的，切成5微米厚的薄片，免疫组织化学染色用于显示Caspase-3，揭示凋亡过程正在进行的脂肪细胞核。
结果：记录的研究结果表明，在使用RF+HIFEM的联合治疗期间，需要43-45°C的温度阈值来启动脂肪细胞凋亡，从而实现脂肪细胞数量的减少。活性组显示阳性染色的细胞核与在评估的切片上发现的所有脂肪细胞核的比率升高-称为凋亡指数(AI)。治疗后8h（47.01±10.56％）和24h（43.58±6.35％），AI显着（p<0.001）增加。Sham组AI无明显变化(p>0.05)。没有观察到与治疗相关的不良事件或副作用。
结论：本研究支持以前发表的RF+HIFEM治疗后脂肪减少的证据，记录治疗后脂肪细胞程序性细胞死亡的安全启动。
方法：在这个双臂中，单中心,随机试验,九名人类受试者被登记并分为两组，用RF+HIFEM处理的活动组(N=6)设定在最高耐受水平,或者用最大RF+HIFEM功率的5%处理的假手术组(N=3),作为一个控制。所有患者均计划进行一次腹部治疗，8小时和24小时两次随访，治疗后7天进行一次安全访视。穿刺活检（直径5毫米，在基线和连续随访时，从腹部区域获得约10mm的深度）。样品是固定的，切成5微米厚的薄片，免疫组织化学染色用于显示Caspase-3，揭示凋亡过程正在进行的脂肪细胞核。
结果：记录的研究结果表明，在使用RF+HIFEM的联合治疗期间，需要43-45°C的温度阈值来启动脂肪细胞凋亡，从而实现脂肪细胞数量的减少。活性组显示阳性染色的细胞核与在评估的切片上发现的所有脂肪细胞核的比率升高-称为凋亡指数(AI)。治疗后8h（47.01±10.56％）和24h（43.58±6.35％），AI显着（p<0.001）增加。Sham组AI无明显变化(p>0.05)。没有观察到与治疗相关的不良事件或副作用。
结论：本研究支持以前发表的RF+HIFEM治疗后脂肪减少的证据，记录治疗后脂肪细胞程序性细胞死亡的安全启动。
