聚左旋乳酸注射与透明质酸注射矫正鼻唇沟的疗效和安全性：一项随机、评估者盲法的对照研究。
Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.
作者信息
Hyun M Y, Lee Y, No Y A, Yoo K H, Kim M N, Hong C K, Chang S E, Won C H, Kim B J
机构信息
Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.
出版信息
Clin Exp Dermatol. 2015 Mar;40(2):129-35. doi: 10.1111/ced.12499. Epub 2014 Oct 15.
BACKGROUND
Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles.
AIM
To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds.
METHODS
In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events.
RESULTS
At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases.
CONCLUSIONS
PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds.
背景
透明质酸（HA）填充剂和聚左旋乳酸（PLA）填充剂常用于矫正面部皱纹。
目的
比较一种新型可注射聚左旋乳酸（PLA）填充剂和一种经过充分研究的双相HA填充剂治疗中重度鼻唇沟的疗效和安全性。
方法
在这项多中心、随机、评估者盲法的对照研究中，受试者被随机分配接受PLA或HA注射到双侧鼻唇沟。通过计算皱纹严重程度评分量表（WSRS）相对于基线的变化来确定疗效。通过报告的不良事件评估局部安全性。
结果
在第24周时，PLA侧WSRS相对于基线的平均改善为2.09±0.68，HA侧为1.54±0.65。两种注射耐受性良好，大多数情况下不良反应轻微且短暂。
结论
在用于治疗中重度鼻唇沟6个月后，PLA与HA相比疗效不劣。
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