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首页> 外文期刊>Journal of cosmetic dermatology >A randomized, split-face, double-blind, comparative study of the safety and efficacy of small- and large-particle hyaluronic acid fillers for the treatment of nasolabial folds
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A randomized, split-face, double-blind, comparative study of the safety and efficacy of small- and large-particle hyaluronic acid fillers for the treatment of nasolabial folds

机译：用于治疗鼻根褶皱的小型和大颗粒透明质酸填料的随机，分裂面，双盲，对比较研究

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Background Injections of hyaluronic acid (HA) for tissue augmentation are one of the most common aesthetic treatments performed worldwide. However, few studies have compared the safety and efficacy of small- and large-particle HA (SP-HA; LP-HA). Aim To assess and compare the safety and efficacy of SP-HA and LP-HA for the correction of nasolabial folds (NLFs). Methods A prospective, split-face, triple-blind study design was used. Ten female subjects were recruited. Patients underwent treatment at baseline, an optional touch up at Week 2, and a follow-up visit at Week 4. At weeks 2 and 4, a blinded reviewer assessed the patients using the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ). At all visits, 3-dimensional imagery and ultrasonography of patients' NLFs were captured. Adverse events (AEs) were evaluated by the Investigator and recorded by subjects in diaries. Results The GAIS response rate, defined as >= "improved" from baseline, was between 90 (2 weeks) and 100% (1 month) for SP-HA and was 100% for LP-HA, at both visits. Paired-samples t tests revealed significant differences in the change in WSRS scores between groups, at both visits (P = one-grade WSRS improvement. There were no severe AEs throughout the trial, nor AEs related to the investigational device. Conclusions LP-HA demonstrates better efficacy for correcting bony resorption in the nasal pyriform region.
机译：背景：注射透明质酸（HA）进行组织增强是世界范围内最常见的美容治疗方法之一。然而，很少有研究比较小颗粒和大颗粒HA（SP-HA；LP-HA）的安全性和有效性。目的评价和比较SP-HA和LP-HA矫正鼻唇沟的安全性和有效性。方法采用前瞻性、裂面、三盲研究设计。招募了10名女性受试者。患者在基线检查时接受了治疗，在第2周进行了可选的修补，并在第4周进行了随访。在第2周和第4周，一位盲法评估者使用全球美感改善量表（GAIS）和皱纹严重程度评定量表（WSRS）对患者进行评估；受试者完成患者满意度问卷（PSQ）。在所有就诊中，患者NLF的三维图像和超声图像均被捕获。不良事件（AE）由研究者评估，并由受试者记录在日记中。结果两次就诊时，SP-HA的GAIS应答率（定义为从基线检查时起>=“改善”）在90（2周）到100%（1个月）之间，LP-HA的GAIS应答率为100%。配对样本t检验显示，两组患者在两次就诊时的WSRS评分变化存在显著差异（P=1级WSRS改善）。整个试验过程中没有出现严重不良事件，也没有与试验装置相关的不良事件。结论LP-HA在矫正鼻梨状区骨吸收方面具有更好的疗效。

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