Stockholm and Solna, Sweden From Akademikliniken; Department of Radiology, Sophiahemmet Hospital Stockholm; and Karolinska University Hospital.
Plast Reconstr Surg. 2013 Oct;132(4):522e-529e. doi: 10.1097/PRS.0b013e31829fe47e.
Macrolane is a biocompatible, biodegradable, injectable stabilized hyaluronic acid-based gel of nonanimal origin manufactured using the nonanimal stabilized hyaluronic acid technology. This was a substudy to evaluate localization, displacement, and degradation of the gel when used for volume restoration and shaping of the buttocks.
Subjects aged 20 years or older seeking buttock augmentation received a maximum volume of 400 ml per subject. Gel localization and degradation up to 24 months after treatment was assessed using magnetic resonance imaging. Subjects carried out a self-assessment of aesthetic improvement using the Global Esthetic Improvement Scale. Safety assessments included adverse event reporting, blood sampling for analysis of systemic inflammatory responses, and body temperature.
Eight subjects received a mean of 163 ml of nonanimal stabilized hyaluronic acid gel per buttock. After 6, 12, and 24 months, respectively, 56, 36, and 24 percent of gel remained in the buttocks, located primarily in the subcutaneous fat. Sixty percent of subjects rated their buttocks as improved up to 24 months after treatment. Over the 24 months, there was no gel displacement outside of the buttocks area, and the aesthetic result was not affected by minor gel displacement within the buttocks. There were no major inflammatory reactions or significant adverse events.
These data demonstrate that nonanimal stabilized hyaluronic acid gel degraded as expected in the buttocks, with minimal displacement. The treatment was well tolerated, and subjects' and investigators' perceptions of aesthetic augmentation of the buttocks remained high, even if only small volumes of the gel remained.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
Macrolane 是一种生物相容性、可生物降解、可注射的、稳定的非动物源透明质酸凝胶，采用非动物稳定透明质酸技术制造。这是一项评估该凝胶用于臀部体积恢复和塑形时的定位、移位和降解的亚研究。
年龄在 20 岁及以上、寻求臀部丰满的受试者，每个臀部接受的最大容量为 400ml。使用磁共振成像评估治疗后 24 个月内凝胶的定位和降解情况。受试者使用全球美学改善量表（Global Esthetic Improvement Scale）对美学改善进行自我评估。安全性评估包括不良事件报告、用于分析全身炎症反应的血液采样和体温。
8 名受试者每侧臀部接受平均 163ml 的非动物稳定透明质酸凝胶。分别在 6、12 和 24 个月后，56%、36%和 24%的凝胶仍留在臀部，主要位于皮下脂肪中。60%的受试者在治疗后 24 个月内认为自己的臀部得到了改善。在 24 个月内，没有凝胶移位到臀部区域之外，并且轻微的凝胶移位不会影响美学效果。没有出现重大炎症反应或严重不良事件。
这些数据表明，非动物稳定透明质酸凝胶在臀部内按预期降解，移位最小。该治疗方法耐受性良好，即使只有少量凝胶残留，受试者和研究者对臀部的美学增强的感知仍然很高。
临床问题/证据水平：治疗，IV 级。
