Braz André, Colucci Ligia, Macedo de Oliveira Luciana, Monteiro Grasiela, Ormiga Patricia, Wanick Fabiana, Cazerta Camila, Kerson Graeme, Musumeci Maria, Silberberg Michael
From the Clínica André Braz, Rio de Janeiro, Brazil.
Clínica Colucci, Belo Horizonte, Brazil.
Plast Reconstr Surg Glob Open. 2024 Feb 12;12(2):e5622. doi: 10.1097/GOX.0000000000005622. eCollection 2024 Feb.
Limited long-term safety data are published on HA/CaHA/L, a hybrid dermal filler combining hyaluronic acid (HA), calcium hydroxyapatite (CaHA), and lidocaine (L).
This retrospective multicenter study assessed treatment-emergent adverse events (TEAEs) in adults treated with HA/CaHA/L. The full analysis set (FAS) included eligible consented adults ( = 403); the long-term safety analysis (LTSA) set included FAS participants with greater than or equal to 12-months HA/CaHA/L exposure ( = 243).
Participants were majority female (94.0%), with Fitzpatrick skin phototypes II/III (80.1%) and a mean age of 50.1 years. Most participants (86.4%) received one HA/CaHA/L treatment. The median time between participants' first HA/CaHA/L treatment and chart review was 15.4 months. Participants received a mean of 2.2 mL (0.5-8.9 mL) filler per treatment. Treated areas were predominantly malar (71.2%) and mandible (69.7%) regions. Most participants (95.0%) had one or more aesthetic treatments other than HA/CaHA/L [eg, other dermal fillers (84.1%), botulinum toxin (63.3%)]. Nineteen (4.7%) FAS participants had 20 documented TEAEs; most (3.5%, = 14 participants) were mild in severity. Twelve TEAEs in 11 participants (2.7%) were related to HA/CaHA/L: induration (three, 0.7%), edema (3, 0.7%), and implant site nodules (five, 1.2%), which were noninflammatory and likely related to product placement. Among the LTSA, 15 (6.2%) participants had 16 documented TEAEs (six edema, five implant site nodules, one inflammation, three skin induration, one hypersensitivity); most were mild in severity. Nine TEAEs in eight participants (3.3%) were HA/CaHA/L-related. No treatment-emergent serious AEs were reported.
The data from this noninterventional retrospective study support the favorable longer term (>12 month) safety profile of HA/CaHA/L.
关于透明质酸（HA）、羟基磷灰石钙（CaHA）和利多卡因（L）混合而成的真皮填充剂HA/CaHA/L，已发表的长期安全性数据有限。
这项回顾性多中心研究评估了接受HA/CaHA/L治疗的成人中出现的治疗突发不良事件（TEAE）。完整分析集（FAS）包括符合条件并签署知情同意书的成人（n = 403）；长期安全性分析（LTSA）集包括HA/CaHA/L暴露时间大于或等于12个月的FAS参与者（n = 243）。
参与者大多数为女性（94.0%），Fitzpatrick皮肤光型为II/III型（80.1%），平均年龄为50.1岁。大多数参与者（86.4%）接受了一次HA/CaHA/L治疗。参与者首次接受HA/CaHA/L治疗与病历审查之间的中位时间为15.4个月。参与者每次治疗平均接受2.2 mL（0.5 - 8.9 mL）填充剂。治疗部位主要是颧骨（71.2%）和下颌骨（69.7%）区域。大多数参与者（95.0%）接受过HA/CaHA/L以外的一种或多种美容治疗[例如，其他真皮填充剂（84.1%）、肉毒杆菌毒素（63.3%）]。19名（4.7%）FAS参与者有20次记录在案的TEAE；大多数（3.5%，n = 14名参与者）为轻度。11名参与者（2.7%）出现的12次TEAE与HA/CaHA/L有关：硬结（3次，0.7%）、水肿（3次，0.7%）和植入部位结节（5次，1.2%），这些均为非炎症性，可能与产品植入有关。在LTSA中，15名（6.2%）参与者有16次记录在案的TEAE（6次水肿、5次植入部位结节、1次炎症、3次皮肤硬结、1次超敏反应）；大多数为轻度。8名参与者（3.3%）出现的9次TEAE与HA/CaHA/L有关。未报告治疗突发严重不良事件。
这项非干预性回顾性研究的数据支持HA/CaHA/L具有良好的长期（>12个月）安全性。
