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新型含利多卡因预混的粘性透明质酸填充剂与单纯透明质酸填充剂注射舒适度的比较。

Comparison of injection comfort of a new category of cohesive hyaluronic acid filler with preincorporated lidocaine and a hyaluronic acid filler alone.

作者信息

Levy Phillip M, De Boulle Koenraad, Raspaldo Hervé

出版信息

Dermatol Surg. 2009 Feb;35 Suppl 1:332-6; discussion 337. doi: 10.1111/j.1524-4725.2008.01045.x.

DOI:10.1111/j.1524-4725.2008.01045.x
PMID:19207322
Abstract

BACKGROUND

A smooth, cohesive, 24-mg/mL hyaluronic acid (HA) gel with uniform consistency, even flow characteristics, and extended duration was designed for injection into the mid to deep dermis.

OBJECTIVE

To compare injection pain of a HA gel with preincorporated lidocaine with that with a non-lidocaine formulation.

METHODS & MATERIALS: This double-blind study at three centers enrolled 60 subjects, injected with both products, randomly assigned to left or right nasolabial fold. The injecting physician assessed severity of pain and ease of injection. Subjects used a visual analog scale (0-10) for pain assessment. Adverse events were recorded. RESULTS Physician assessment of injection pain was none or mild in 81% of HA gel injections with preincorporated lidocaine and 36% of HA-alone injections (p<.001). Mean pain assessment by subjects was 3.6 for HA+lidocaine and 5.8 for HA alone (p<.001). Ninety-five percent of the injections were considered easy or very easy; a greater percentage of HA+lidocaine injections were rated very easy. Mild to moderate adverse events were reported for both products.

CONCLUSION

The smooth, cohesive HA gel with preincorporated lidocaine increased subject comfort during treatment and improved the injection experience.

摘要

背景

设计了一种质地均匀、具有良好粘性、浓度为24mg/mL的透明质酸(HA)凝胶,其质地均匀、流动特性良好且作用持久,用于真皮中层至深层注射。

目的

比较预先加入利多卡因的HA凝胶与未添加利多卡因制剂的注射疼痛情况。

方法与材料

这项在三个中心开展的双盲研究纳入了60名受试者,两种产品均进行注射,随机分配至左侧或右侧鼻唇沟。注射医生评估疼痛严重程度和注射难易程度。受试者使用视觉模拟量表(0-10)进行疼痛评估。记录不良事件。结果:在预先加入利多卡因的HA凝胶注射中,81%的注射疼痛评估为无或轻度,而单纯HA注射的这一比例为36%(p<0.001)。受试者对HA+利多卡因的平均疼痛评分为3.6,单纯HA为5.8(p<0.001)。95%的注射被认为容易或非常容易;HA+利多卡因注射中评为非常容易的比例更高。两种产品均报告了轻度至中度不良事件。

结论

预先加入利多卡因的质地均匀、具有良好粘性的HA凝胶在治疗期间提高了受试者的舒适度并改善了注射体验。

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