Liu Tantan, Qiang Shuai, Wang Na, Wei Siming, Qiu Lihong, Xiong Shaoheng, Ma Xianjie, Zhang Zhaoxiang, Yi Chenggang
Department of Pathology, Xijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, Shaanxi, China.
Department of Plastic and Reconstructive Surgery, Xijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, 710032, Shaanxi, China.
Aesthetic Plast Surg. 2024 Dec;48(24):5342-5349. doi: 10.1007/s00266-024-04342-1. Epub 2024 Sep 16.
Botulinum toxin A (BTX-A) can enhance the efficacy of fat grafting. However, most studies conducted animal experiments, lacked objective clinical data, or were non-randomized controlled trials. Thus, objective evaluation of the clinical effectiveness of BTX-A is still elusive.
A randomized, self-controlled trial (2020-2022) on 16 patients who underwent bilateral autogenous fat breast augmentation was performed with each patient receiving autologous fat graft and BTX-A on one side and fat graft and equal volume of saline on the other side. All patients were followed. The effects of BTX-A were evaluated objectively by comparing the remaining bilateral fat graft volumes obtained through digital three-dimensional reconstruction. The improvement of each breast appearance and complication were assessed by the physician and patients who were blinded to the treatment.
The outcome of fat breast augmentation was evident for both sides at follow-up with no evidence of fat embolism, vascular/nervous injury, infection, and prolonged bruising. The analysis of the three-dimensional reconstruction data and assessments from both physicians and patients showed significant differences in the fat graft retention volume between the BTX-A side and the control side. No significant difference was found in the incidence of complications between the two sides.
Autogenous fat breast augmentation is safe and effective. This study shows that BTX-A can significantly improve the retention rate of fat transplantation, but cannot reduce complications. Trial registration This study was registered prior to patient enrollment (ClinicalTrials.gov identifier:ChiCTR2100054878).
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A型肉毒杆菌毒素（BTX-A）可提高脂肪移植的效果。然而，大多数研究进行的是动物实验，缺乏客观的临床数据，或为非随机对照试验。因此，对BTX-A临床疗效的客观评估仍然难以实现。
对16例行双侧自体脂肪隆胸的患者进行了一项随机、自身对照试验（2020 - 2022年），每位患者一侧接受自体脂肪移植和BTX-A，另一侧接受脂肪移植和等量生理盐水。对所有患者进行随访。通过数字三维重建比较双侧剩余脂肪移植体积，客观评估BTX-A的效果。由对治疗不知情的医生和患者评估每侧乳房外观的改善情况及并发症。
随访时双侧脂肪隆胸效果均明显，无脂肪栓塞、血管/神经损伤、感染及长期瘀斑的证据。三维重建数据分析以及医生和患者的评估均显示，BTX-A侧与对照侧的脂肪移植保留体积存在显著差异。两侧并发症发生率无显著差异。
自体脂肪隆胸安全有效。本研究表明，BTX-A可显著提高脂肪移植的保留率，但不能降低并发症发生率。试验注册本研究在患者入组前进行了注册（ClinicalTrials.gov标识符：ChiCTR2100054878）。
证据水平IV：本刊要求作者为每篇文章指定证据水平。有关这些循证医学评级的完整描述，请参阅目录或作者在线指南www.springer.com/00266 。
