Skin Research Institute, LLC, Coral Gables, Florida.
Clinical Testing of Beverly Hills, Beverly Hills, California.
Dermatol Surg. 2022 Oct 1;48(10):1065-1070. doi: 10.1097/DSS.0000000000003541. Epub 2022 Jul 13.
Maximizing patient comfort during hyaluronic acid gel injection is a common concern that is usually addressed by selecting fillers with lidocaine.
Two randomized, double-blinded, split-face trials aimed to demonstrate noninferiority of specific hyaluronic acid fillers incorporating mepivacaine (RHA-M) versus their lidocaine controls, at providing pain relief.
Thirty subjects per trial received injections of RHA R -M versus RHA R , and RHA4-M versus RHA4, respectively, in the perioral rhytids (PR) and nasolabial folds (NLF). Pain was assessed on a visual analog scale; aesthetic effectiveness was evaluated with validated scales, and safety was monitored based on common treatment responses (CTRs) and adverse events (AEs).
RHA-M fillers proved as effective as their lidocaine counterparts at reducing pain (noninferior, p < .0002 and p < .0001). Bilateral wrinkle improvement was measured both in the PR (-1.5 ± 0.6 points on each side) and in the NLF (-1.8 ± 0.6 and -1.9 ± 0.5 points) trials at one month, with virtually identical responder rates (≥96.7%). Common treatment responses and AEs were similar between treated sides, and none was clinically significant.
Resilient hyaluronic acid fillers with either mepivacaine or lidocaine are equally effective at reducing pain during treatment and equally performant and safe for correction of dynamic facial wrinkles and folds.
在透明质酸凝胶注射过程中最大限度地提高患者舒适度是一个常见的关注点，通常通过选择含有利多卡因的填充物来解决。
两项随机、双盲、对照的分割面试验旨在证明含有甲哌卡因的特定透明质酸填充物（RHA-M）与含有利多卡因的对照填充物（RHA-R 和 RHA4-M 与 RHA4）在提供疼痛缓解方面具有非劣效性。
每个试验中，30 名受试者分别接受 RHA-R-M 与 RHA-R 以及 RHA4-M 与 RHA4 在口周皱纹（PR）和鼻唇沟（NLF）中的注射。使用视觉模拟量表评估疼痛；使用经过验证的量表评估美学效果，并根据常见治疗反应（CTR）和不良反应（AE）监测安全性。
RHA-M 填充物在减轻疼痛方面与含有利多卡因的对照填充物一样有效（非劣效，p <.0002 和 p <.0001）。在一个月时，在 PR（每侧 -1.5 ± 0.6 分）和 NLF（-1.8 ± 0.6 和 -1.9 ± 0.5 分）试验中均测量到双侧皱纹改善，应答率几乎相同（≥96.7%）。治疗侧之间的常见治疗反应和不良反应相似，且均无临床意义。
含有甲哌卡因或利多卡因的弹性透明质酸填充物在治疗过程中减轻疼痛方面同样有效，并且对于纠正动态面部皱纹和褶皱同样有效且安全。
