现代仪器与医疗

电磁塑肌仪在腹部及臀部塑形中的临床应用有效性及安全性研究

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张睿 ¹^,²^,³ , 张劼 ¹^,² , 卢莎 ¹^,²^,^*

现代仪器与医疗 | 医学工程 2026,32(3): 34-44

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现代仪器与医疗 |医学工程 2026 , 32 (3) : 34 -44

电磁塑肌仪在腹部及臀部塑形中的临床应用有效性及安全性研究

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张睿¹^,²^,³, 张劼¹^,², 卢莎¹^,²^,^*

作者信息

^1.上海微创医疗器械（集团）有限公司，上海　201203

^2.上海微创介入与植入器械工程技术研究中心，上海　201203

^3.上海微创惟美医疗科技（集团）有限公司，上海　201203

通讯作者:

卢莎，女，博士研究生，高级工程师，研究方向：医疗器械

作者简介:

张睿，男，博士研究生，高级工程师，研究方向：医疗器械

Clinical study on the efficacy and safety of electromagnetic muscle toning devices in abdominal and gluteal contouring

Rui Zhang¹^,²^,³, Jie Zhang¹^,², Sha Lu¹^,²^,^*

Affiliations

^1.Shanghai Microport Medical (Group) Co., Ltd., Shanghai 201203, China

^2.Shanghai Minimally Invasive Intervention and Implantable Instruments Engineering Technology Research Center, Shanghai 201203, China

^3.MicroPort AesthMed Shanghai (Group) Co., Ltd., Shanghai 201203, China

出版时间: 2026-06-10 doi: 10.11876/mimt202603005

文章导航

摘要

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目的

系统评估国产骊塑电磁塑肌仪（NEOSCULPT）基于高强度聚焦电磁场（high-intensity focused electromagnetic field，HIFEM）技术对腹部和臀部塑形的效果及其安全性。

方法

采用前瞻性自身对照临床试验，分臀部、腹部两阶段进行，各纳入32名健康受试者。所有受试者均接受为期4周、每周2次、每次30 min的靶向电磁干预，共计8次。于干预前、第8次干预后及干预结束后1个月行人体维度测量、MRI影像学分析、人体成分检测及血尿生化指标检测，记录不良事件发生情况。

结果

臀部干预后，总体臀围平均增长2.2%（P<0.001），女性腰臀比平均改善6.7%（P<0.01）。腹部干预后，男性腹部肌肉面积增长6.3%（P<0.01）、脂肪面积减少10.4%（P<0.001）；女性腹部肌肉面积增长11.8%（P<0.001）、脂肪面积减少7.5%（P<0.01）。整体增肌减脂有效率达80%左右，全身体脂率平均下降1%（P<0.001），腹部皮下脂肪厚度平均减少8.2%（P<0.001），上述效果在随访期基本维持。除肌酸激酶呈运动后生理性升高外，血尿生化指标无异常波动；仅1例肾功能变化，经处理后恢复，无严重不良事件发生。

结论

骊塑电磁塑肌仪显著增加受试者臀部围度，提升臀形紧致度，同时实现腹部肌肉增长与脂肪减少的双重效应，且临床应用安全性优异，为国产非侵入性塑形设备的临床应用提供了高质量循证依据。

关键词

高强度聚焦电磁场 / 电磁塑肌仪 / 骊塑 / 增肌减脂 / 身体塑形

Abstract

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Objective

This paper systematically evaluates the efficacy and safety of the domestic electromagnetic muscle toning device called NEOSCULPT, which is based on high-intensity focused electromagnetic field (HIFEM) technology for abdominal and gluteal contouring.

Methods

A prospective self-controlled clinical trial was conducted in two phases (gluteal and abdominal), each involving 32 healthy subjects. All subjects received targeted electromagnetic interventions twice a week for 30 minutes each session over a period of 4 weeks. Body circumference measurements, MRI imaging analysis, body composition analysis, and blood and urine biochemical tests were performed at baseline, at the end of the intervention, and one month post-intervention. Adverse events were recorded.

Results

Following the gluteal intervention, the average overall hip circumference increased by 2.2% (P<0.001), and the average waist-to-hip ratio in females improved by 6.7% (P<0.01). Following the abdominal intervention, male subjects showed a 6.3% increase in abdominal muscle area (P<0.01) and a 10.4% decrease in fat area (P<0.001); female subjects showed an 11.8% increase in abdominal muscle area (P<0.001) and a 7.5% decrease in fat area (P<0.01). The overall efficacy rate for muscle enhancement and fat reduction was 80%, with an average reduction of 1% in total body fat percentage (P<0.001) and an average reduction of 8.2% in abdominal subcutaneous fat thickness (P<0.001). These effects were generally maintained during the follow-up period. Apart from a physiological increase in creatine kinase levels post-exercise, no abnormal fluctuations were observed in blood and urine biochemical parameters. Only one case experienced changes in renal function, which recovered after treatment, with no serious adverse events occurring.

Conclusion

The NEOSCULPT electromagnetic muscle toning device significantly increased participants' gluteal circumference and improved gluteal firmness, while simultaneously achieving dual effects of abdominal muscle growth and fat reduction, with excellent clinical application safety. These findings provide high-quality evidence-based support for the clinical application of domestically produced non-invasive muscle enhancement devices.

Key words

High-intensity focused electromagnetic field (HIFEM) / Electromagnetic muscle toning device / NEOSCULPT / Muscle enhancement and fat reduction / Body contouring

引用本文

张睿, 张劼, 卢莎. 电磁塑肌仪在腹部及臀部塑形中的临床应用有效性及安全性研究. 现代仪器与医疗, 2026 , 32 (3) : 34 -44 . DOI: 10.11876/mimt202603005

Rui Zhang, Jie Zhang, Sha Lu. Clinical study on the efficacy and safety of electromagnetic muscle toning devices in abdominal and gluteal contouring[J]. Modern Instruments & Medical Treatment, 2026 , 32 (3) : 34 -44 . DOI: 10.11876/mimt202603005

基金

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国家重点研发计划“射频治疗设备性能评价与质控关键技术研究”(2023YFC2414300)

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2026年第32卷第3期

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文章信息

doi: 10.11876/mimt202603005

接收时间：2026-04-02
首发时间：2026-10-23
出版时间：2026-06-10

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出版历史

收稿日期：2026-04-02

基金

国家重点研发计划“射频治疗设备性能评价与质控关键技术研究”(2023YFC2414300)

作者信息

^1.上海微创医疗器械（集团）有限公司，上海　201203

^2.上海微创介入与植入器械工程技术研究中心，上海　201203

^3.上海微创惟美医疗科技（集团）有限公司，上海　201203

通讯作者:

卢莎，女，博士研究生，高级工程师，研究方向：医疗器械

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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