Servicio de Dermatología, Hospital Universitario Ramon y Cajal, Madrid, Spain.
Clínica Dra Paloma Cornejo, Madrid, Spain.
J Cosmet Dermatol. 2022 Jul;21(7):2939-2944. doi: 10.1111/jocd.14583. Epub 2021 Nov 12.
Pliaglis is a self-occluding topical anesthetic containing a eutectic mixture of 7% lidocaine and 7% tetracaine, with proven efficacy and safety in several trials.
To evaluate the effectiveness and safety of Pliaglis for different dermatological procedures in real-life clinical practice.
This retrospective, multicenter study included 35 patients treated with Pliaglis prior to five dermatological procedures (pulsed dyed laser, picosecond laser, non-ablative fractional laser, radiofrequency microneedling, and photodynamic therapy). The primary endpoint was to assess the pain during the procedure with a visual analogue score (VAS) from 0 (no pain) to 10 (most severe pain). Secondary endpoints were the global effectiveness and tolerability (from 0 = very low to 10 = excellent), and the adverse events (AEs) after Pliaglis removal, classified according to intensity (1-3).
The median and mean pain VAS reported by patients was 2 (range 0-9) and 2.9 (±2.3), respectively. More than 65% of the patients had a VAS score ≤3. The effectiveness reported by investigators was "very good" (median 8 [range 2-10], mean 7.5 [±1.9]), which was strongly correlated with the pain VAS reported by patients (Spearman coefficient = - 0.9; p < 0.001). Forty-five percent of patients reported AEs and they were transient and mostly mild, with a mean intensity score of 1.5 (range 1-3). Tolerability of Pliaglis was reported by investigators as "excellent" (median 10 [range 1-10], mean 9 [±1.8]).
Pliaglis is an effective topical anesthetic for several dermatological procedures, with an excellent safety and tolerability profile.
Pliaglis 是一种自闭塞的局部麻醉剂，含有 7%利多卡因和 7%丁卡因的共晶混合物，在几项试验中已被证实具有疗效和安全性。
评估 Pliaglis 在真实临床实践中用于不同皮肤科手术的有效性和安全性。
这是一项回顾性、多中心研究，纳入了 35 例在接受五种皮肤科手术（脉冲染料激光、皮秒激光、非剥脱性点阵激光、射频微针和光动力疗法）前使用 Pliaglis 的患者。主要终点是使用视觉模拟评分（VAS）从 0（无痛）到 10（最剧烈疼痛）评估手术过程中的疼痛程度。次要终点是总体有效性和耐受性（从 0=非常低到 10=极好），以及 Pliaglis 去除后的不良事件（AE），根据强度（1-3 级）进行分类。
患者报告的 VAS 中位数和平均值疼痛分别为 2（范围 0-9）和 2.9（±2.3）。超过 65%的患者 VAS 评分≤3。研究者报告的有效性为“非常好”（中位数 8 [范围 2-10]，平均值 7.5 [±1.9]），与患者报告的 VAS 疼痛评分呈强相关（Spearman 系数为-0.9；p<0.001）。45%的患者报告了 AE，这些 AE 是短暂的，且大多为轻度，平均强度评分为 1.5（范围 1-3）。研究者报告 Pliaglis 的耐受性为“极好”（中位数 10 [范围 1-10]，平均值 9 [±1.8]）。
Pliaglis 是一种用于多种皮肤科手术的有效局部麻醉剂，具有极好的安全性和耐受性。
