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注射用聚左旋乳酸改善皮肤质量的随机对照多中心双盲研究
Investigation of Injectable Poly-L-Lactic Acid for
简介
【 文献重点摘要 】
Background: Poly-L-lactic acid (PLLA) is an injectable filler used for restoring facial fat volume loss.
Objective: To evaluate the effect of repeated PLLA injections on skin quality.
Methods: Forty healthy women were enrolled in this randomized, controlled, double-blind, multicenter study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections, into both sides of the face. Follow-up visits were at 6, 9, and 12 after the last treatment. Assessments included biophysical measuring instruments, live ratings, patient questionnaires, and rating of standardized pictures by a blinded evaluator.
Results: At the 12-month follow-up, there was a statistically significant increase of skin elasticity and hydration in PLLA-treated subjects and a decrease in transepidermal water loss in both groups. Pigmentation, erythema, and pore size were significantly decreased, whereas radiance and smoothness were significantly increased at 12 months per blinded investigator rating in this group. No treatment-related adverse events occurred.
Conclusion: Repeated PLLA treatments may improve skin quality in a time-dependent manner.
背景：聚左旋乳酸(PLLA)是一种用于修复面部脂肪体积减少的注射性填充物。
目的：评价多次注射聚左旋乳酸对皮肤质量的影响。
方法：40名健康女性参加这项随机、对照、双盲、多中心研究。符合条件的受试者每4周接受3次治疗，分别在面部两侧注射PLLA(治疗组)或生理盐水(对照组)。最后一次治疗后随访时间分别为6、9和12次。评估包括生物物理测量仪器，现场评分，患者问卷，以及盲评者对标准化图片的评分。
结果：在12个月的随访中，PLLA治疗的受试者的皮肤弹性和水合能力有统计学意义的增加，两组的经表皮失水都减少了。在这组中，色素沉着、红斑和毛孔大小显著减少，而光泽度和平滑度在每名盲目调查者评分12个月时显著增加。未发生与治疗相关的不良事件。
结论：反复PLLA治疗可时间依赖性地改善皮肤质量。
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