【 文献重点摘要 】
 

Cohesive polydensified matrix (CPM®) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM® fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM® fillers. Performance was assessed using the Merz Aesthetics Scales® (MAS). Pain was rated on an 11-point visual analog scale. Patients’ and physicians’ satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM® fillers with lidocaine are safe and effective for a wide range of esthetic facial indications.

Keywords: cohesive polydensified matrix, dermal fillers, Belotero, Esthélis, Fortélis, Modélis

粘聚型增密基质(CPM®)透明质酸填充物现在可以添加或不添加利多卡因。本研究的目的是研究含利多卡因的CPM®填充物在临床环境中的安全性和性能。在一项开放标签的前瞻性上市后研究中，来自德国和丹麦7个地点的108名患者接受了一种或多种含有利多卡因的CPM®填充剂的治疗。使用Merz Aesthetics Scales®(MAS)对性能进行评估。疼痛评分采用11分视觉模拟评分。记录患者和医生的满意度以及不良事件。与基线相比，约90%的患者在治疗后即刻和17天后MAS≥1点的评分有所改善。所有研究人员评估的射血力、产品位置和性能与相应的非利多卡因产品相似或更好。总体而言，94%的调查人员对美容效果感到满意，并愿意继续使用该产品。除一名患者外，所有患者都对结果感到满意，并且都愿意重复治疗。平均疼痛评分在注射过程中(<3.0)和注射后(<0.6)较低。除1例擦伤外，所有不良反应均为轻至中度。含利多卡因的CPM®填充物适用于各种美容面部适应症，安全有效。

关键词：粘合增密基质，真皮填料，Belotero，Esthélis，Fortélis，Modélis