Coppini M, Caponio V C A, Mauceri R, Pizzo G, Mauceri N, Lo Muzio L, Campisi G
Department of Precision Medicine in Medical, Surgical and Critical Care, University of Palermo, Palermo, Italy.
Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
Front Oral Health. 2024 Oct 17;5:1495012. doi: 10.3389/froh.2024.1495012. eCollection 2024.
In the last decades, dermal fillers have gained widespread acceptance for cosmetic purposes since their approval for different health conditions, including lip augmentation and aesthetic intervention of the face. Unfortunately, while filler lip procedures are performed using biomaterials with improved physical characteristics, they are not devoid of adverse drug reactions (ADRs), including those with late-onset.
This systematic aims to investigate the ADRs associated with lip augmentation procedures using dermal fillers. A systematic review search was conducted in Medline/PubMed, Scopus, Web of Science to answer the PEO question: What are the ADRs in patients undergoing lip augmentation procedures with dermal fillers, and how frequent are they?
The risk of bias was assessed, and a systematic review was conducted. Nineteen studies were included. In total, 30 patients affected by filler lip ADRs were analyzed, of which 29 were females and only 1 was male with a mean age of 50.9 ± 12.8 years. Hyaluronic acid was the most commonly dermal filler used and granulomatous foreign body reaction was the most common filler lip reaction reported. The mean time between filler lip injection and granulomatous foreign body reaction onset was 57.9 ± 54 months (median 24 months).
No study reported ADRs to regulatory authorities. Our results indicate that adverse reactions can occur even long-term after the aesthetic procedure. Therefore, ongoing short-term and long-term follow-up visits are essential, as biocompatible materials are not free from ADRs. Additionally, a lack of reporting ADRs to regulatory authorities has emerged, which is crucial for patient safety.
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=534656, identifier: CRD42024534656.
在过去几十年中，自真皮填充剂被批准用于不同健康状况（包括丰唇和面部美学干预）以来，其在美容领域已获得广泛认可。不幸的是，尽管填充剂丰唇手术使用了具有改善物理特性的生物材料，但它们并非没有药物不良反应（ADR），包括迟发性不良反应。
本系统综述旨在研究与使用真皮填充剂进行丰唇手术相关的ADR。在Medline/PubMed、Scopus、Web of Science中进行了系统综述检索，以回答PEO问题：接受真皮填充剂丰唇手术的患者中ADR有哪些，其发生频率如何？
评估了偏倚风险，并进行了系统综述。纳入了19项研究。总共分析了30例受填充剂丰唇ADR影响的患者，其中29例为女性，仅1例为男性，平均年龄为50.9±12.8岁。透明质酸是最常用的真皮填充剂，肉芽肿性异物反应是报告的最常见的填充剂丰唇反应。填充剂丰唇注射与肉芽肿性异物反应发作之间的平均时间为57.9±54个月（中位数24个月）。
没有研究向监管机构报告ADR。我们的结果表明，即使在美容手术后很长时间也可能发生不良反应。因此，持续的短期和长期随访至关重要，因为生物相容性材料并非没有ADR。此外，已出现未向监管机构报告ADR的情况，这对患者安全至关重要。
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=534656，标识符：CRD42024534656。
