一项前瞻性临床试验评估非动物稳定透明质酸注射液用于非手术鼻成形术的疗效和安全性

IF 0.7 4区 医学 Q4 SURGERY
Plastic surgery Pub Date : 2025-02-01 Epub Date: 2023-07-12 DOI:10.1177/22925503231184263
Andreas Nikolis, Kaitlyn M Enright, Quynh Nguyen, Hani H Sinno, Sebastian Cotofana
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引用次数: 0

摘要

背景:使用透明质酸(HA)填充物的非手术鼻整形术是一种三维整形技术,通过将透明质酸深入鼻腔皮肤来实现组织增强。由于其独特的流变性,Restylane®Lyft(HA-L,Galderma,Uppsala,Sweden)可能特别适合注射鼻整形术,因为它具有高凝胶硬度(G'),可提供强大的结构支撑,且整合倾向最小。方法:进行前瞻性临床试验,评价HA-L在非手术鼻整形术中的应用。在八个月内观察了33名女性,使用以下时间表:访视1 = 基线/治疗1;访视2 = 可选补漆(第2周);访问3-6 = 随访(第1、3、6、8个月)。主要终点是受试者在第1个月时的改善,由盲法评估者使用全球美学改善量表(GAIS)进行评估。还评估了受试者满意度和不良事件(AE)。结果:最常用的是使用团注技术和0.34cc的HA-L进行深层骨膜注射。在6/33(18.18%)受试者中,167个注射点出现7例阳性抽吸(4.19%)。根据GAIS,100%的受试者达到了主要终点。受试者满意度在第1个月达到最高(100%),在第8个月基本保持(78.57%)。除了预期的注射相关AE(如瘀斑、红斑)外,治疗期间/治疗后的即时AE仅限于发作前症状[5/33名受试者(15.15%)]。重要的是,未观察到缺血病例。受试者报告的AE(如肿胀、红斑、疼痛)在2至7天内消失。结论:鉴于该技术的技术性质,HA-L可能非常适合用于注射鼻成形术,因为它具有很强的安全性和有效性。证据水平:第三级:从精心设计的队列研究中获得的证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Prospective Clinical Trial Evaluating the Efficacy and Safety of Non-Animal Stabilized Hyaluronic Acid Injections for Non-Surgical Rhinoplasty.

Background: Non-surgical rhinoplasty with hyaluronic acid (HA) filler is a three-dimensional reshaping technique that achieves tissue enhancement by placing HA deep to nasal skin. Due to its unique rheology, Restylane® Lyft (HA-L, Galderma, Uppsala, Sweden) may be particularly well-suited for injection rhinoplasty, as it has high gel firmness (G') for strong structural support with minimal integration propensity. Methods: A prospective clinical trial was conducted to evaluate HA-L use for non-surgical rhinoplasty. Thirty-three females were observed over eight months, using the following schedule: Visit 1 = Baseline/Treatment 1; Visit 2 = Optional touch up (Week 2); Visits 3-6 = Follow-ups (Months 1,3,6,8). The primary endpoint was subject improvement at Month 1 assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). Subject satisfaction and adverse events (AEs) were also evaluated. Results: A deep, periosteal injection using a bolus technique and 0.34 cc of HA-L was most often used. Seven cases of positive aspiration occurred in 167 injection points (4.19%), among 6/33 (18.18%) subjects. Based on the GAIS, 100% of subjects met the primary endpoint. Subject satisfaction was maximal at Month 1 (100%) and largely maintained at Month 8 (78.57%). Besides expected injection-related AEs (eg, ecchymosis, erythema), immediate AEs during/following treatment were limited to presyncopal symptoms [5/33 subjects (15.15%)]. Importantly, no cases of ischemia were observed. Subject-reported AEs (eg, swelling, erythema, pain) dissipated within 2 to 7 days. Conclusion: Given the technical nature of this technique, HA-L may be well-suited for injection rhinoplasty, due to its strong safety and efficacy profile. Level of Evidence: Level III: Evidence obtained from well-designed cohort study.

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来源期刊
Plastic surgery
Plastic surgery Medicine-Surgery
CiteScore
1.70
自引率
0.00%
发文量
73
期刊介绍: Plastic Surgery (Chirurgie Plastique) is the official journal of the Canadian Society of Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery, Group for the Advancement of Microsurgery, and the Canadian Society for Surgery of the Hand. It serves as a major venue for Canadian research, society guidelines, and continuing medical education.
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