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使用套管注射弹性透明质酸填充剂的疗效和安全性:一项随机、评估者盲法、半脸对照研究。

Efficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study.

作者信息

Beer Kenneth, Biesman Brian, Cox Sue Ellen, Smith Stacy, Picault Laura, Trevidic Patrick

机构信息

Beer Dermatology, West Palm Beach, FL, USA.

Private Practice, Nashville, TN, USA.

出版信息

Clin Cosmet Investig Dermatol. 2023 Apr 6;16:959-972. doi: 10.2147/CCID.S402315. eCollection 2023.

Abstract

PURPOSE

Cannulas are increasingly used for injecting hyaluronic acid fillers, as they are thought to improve patient comfort safety and treatment tolerability. This study aimed to demonstrate the non-inferiority of a Resilient Hyaluronic Acid 4 (RHA 4) filler injected with a cannula versus a needle for the treatment of moderate to severe nasolabial folds (NLF).

PATIENTS AND METHODS

A total of 50 subjects were included in a randomized, evaluator-blinded, split-face trial. The NLF were injected with RHA 4 using a cannula on one side of the face and using a needle on the other side on Day 0. A touch-up could be performed 4 weeks later. The subjects were followed up for 12 weeks after the last injection, ie, injection on Day 0 or touch-up. Efficacy was evaluated using a Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and patient-reported outcomes. Safety assessments included the injection-site pain, common treatment reactions (CTRs), and adverse events (AEs).

RESULTS

Twelve weeks after the last injection, the efficacy of the cannula treatment was found to be non-inferior to that of the needle treatment, based on the WSRS score improvements. The other study endpoints showed the equivalent efficacy and safety of the two methods. No serious or unexpected AEs were reported.

CONCLUSION

RHA 4 may be effectively and safely injected into the NLF using a cannula or a needle, provided it is administrated by a trained practitioner.

摘要

目的

套管越来越多地用于注射透明质酸填充剂,因为人们认为它能提高患者的舒适度、安全性和治疗耐受性。本研究旨在证明用套管注射弹性透明质酸4(RHA 4)填充剂与用针头注射相比,在治疗中重度鼻唇沟(NLF)方面的非劣效性。

患者和方法

共有50名受试者纳入一项随机、评估者盲法、半脸试验。在第0天,一侧面部使用套管,另一侧面部使用针头,将RHA 4注射到鼻唇沟中。4周后可进行补打。在最后一次注射(即第0天的注射或补打)后对受试者进行12周的随访。使用皱纹严重程度评定量表(WSRS)、整体美学改善量表(GAIS)和患者报告的结果评估疗效。安全性评估包括注射部位疼痛、常见治疗反应(CTR)和不良事件(AE)。

结果

最后一次注射12周后,根据WSRS评分改善情况,发现套管治疗的疗效不劣于针头治疗。其他研究终点显示两种方法的疗效和安全性相当。未报告严重或意外的不良事件。

结论

只要由训练有素的从业者进行注射,RHA 4可以使用套管或针头有效且安全地注射到鼻唇沟中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4658/10082220/dd42258383be/CCID-16-959-g0001.jpg

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