一项关于小颗粒透明质酸加利多卡因套管注射（SPHAL）丰唇的多中心、开放标签、前瞻性研究。

A Multi-Center, Open-Label, Prospective Study of Cannula Injection of Small-Particle Hyaluronic Acid Plus Lidocaine (SPHAL) for Lip Augmentation.

作者信息

Chopra Raj, Graivier Miles, Fabi Sabrina, Nestor Mark, Meuse Patricia, Mashburn Jay

出版信息

J Drugs Dermatol. 2018 Jan 1;17(1):10-16.

PMID:29320583

Abstract

BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler in the lip and perioral area has gained popularity as they provide important safety-related advantages compared to traditional hypodermic needles. This study was conducted to assess the safety and effectiveness associated with the use of a blunt-tipped microcannula for lip augmentation and correction of perioral rhytids using a small-particle, hyaluronic acid gel plus lidocaine (SPHAL).

METHODS: A multi-center, open-label, prospective, study enrolled 60 subjects. Subjects reported injection-related events (IREs) for 2 weeks posttreatment via diary. Adverse events (AEs) were collected throughout the study. Secondary assessments at 4 and 12 weeks posttreatment included treating investigator- and subject-reported improvement in lip fullness using the Global Aesthetic Improvement Scale (GAIS) and investigator-assessed improvement in lip fullness using the Medicis Lip Fullness Scale (MLFS).

RESULTS: Sixty subjects were enrolled and treated with a mean total volume (ie, both lips and optional perioral rhytids) of 2.2 mL. Treatment-emergent adverse events (TEAEs) reported and assessed as related to the product and/or injection procedure included injection site swelling (13.3%), injection site bruising (6.7%), and injection site pain (1.7%). These were typically mild and transient in nature. No serious AEs (SAEs) were reported. Following treatment, clinically significant improvement using the GAIS and MLFS was demonstrated throughout the study (GAIS improvement at week 12 for both lips: investigator-reported, 98.0%; subject-reported, 84.3%; MLFS improvement at week 12: investigator-reported, 96.1%).

CONCLUSION: SPHAL was well tolerated and effective following injection with a blunt-tipped microcannula. No unanticipated safety concerns were identified in the study population.

J Drugs Dermatol. 2018;17(1):10-16.

摘要

背景

钝头微套管用于在唇部和口周区域注射透明质酸（HA）填充剂已越来越受欢迎，因为与传统皮下注射针头相比，它们具有重要的安全相关优势。本研究旨在评估使用钝头微套管联合小颗粒透明质酸凝胶加利多卡因（SPHAL）进行唇部填充和口周皱纹矫正的安全性和有效性。

方法

一项多中心、开放标签、前瞻性研究纳入了60名受试者。受试者通过日记记录治疗后2周内的注射相关事件（IREs）。在整个研究过程中收集不良事件（AE）。治疗后4周和12周的二次评估包括使用全球美学改善量表（GAIS）由治疗医生和受试者报告的唇部丰满度改善情况，以及使用美迪西唇部丰满度量表（MLFS）由医生评估的唇部丰满度改善情况。

结果

60名受试者入组并接受治疗，平均总体积（即双侧唇部和可选的口周皱纹）为2.2 mL。报告并评估为与产品和/或注射程序相关的治疗中出现的不良事件（TEAE）包括注射部位肿胀（13.3%）、注射部位瘀斑（6.7%）和注射部位疼痛（1.7%）。这些通常性质轻微且为短暂性。未报告严重不良事件（SAE）。治疗后，在整个研究过程中使用GAIS和MLFS均显示出临床上显著的改善（12周时双侧唇部GAIS改善：医生报告为98.0%；受试者报告为84.3%；12周时MLFS改善：医生报告为96.1%）。