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与非手术面部美容用透明质酸填充剂注射相关的不良事件:高证据水平研究的系统评价。

Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies.

机构信息

Department of Plastic Surgery, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Papageorgiou General Hospital, 56403, Thessaloniki, Greece.

Zambacos Plastic Surgery Center, Athens, Greece.

出版信息

Aesthetic Plast Surg. 2024 Feb;48(4):719-741. doi: 10.1007/s00266-023-03465-1. Epub 2023 Aug 10.

Abstract

BACKGROUND

Hyaluronic acid (HA) dermal fillers are widely used in aesthetic medicine. While generally safe, potential complications can arise.

OBJECTIVE

This systematic review aims to identify and classify potential complications linked to the use of HA dermal fillers, as informed by high-quality, low-risk-of-bias studies.

METHODS

This review follows the Cochrane review standards for clinical systematic reviews. This systematic review analyzed 48 high level of evidence studies on the use of hyaluronic acid (HA) dermal fillers in non-surgical facial aesthetics and the adverse events that occurred.The inclusion criteria were randomized control studies on HA dermal fillers and their complications. Excluded were case reports, case series, observational studies, and other non-randomized research due to their inability to provide generalized conclusions and their inherent publication bias.

RESULTS

Adverse events were classified into three categories: expected reactions, product or technique-related adverse events, and severe adverse events. Most adverse events were short-lived injection site reactions, which resolved spontaneously. Specific HA fillers and injection techniques influenced the occurrence of adverse events, which generally resolved within weeks without treatment. Severe adverse events were rare, persisting for months and requiring active medical intervention.

DISCUSSION

This classification system can enhance understanding, prevention, and treatment of HA filler complications, and support patient education. The common complications were injection site reactions, with persistent symptoms treated with topical steroids, NSAIDs, or hyaluronidase. Severe complications included severe edema, angioedema and others, often necessitating specific treatments.

CONCLUSION

HA dermal fillers are generally safe and effective, with most adverse events being transient and mild to moderate in severity. Severe adverse events, although rare, do occur and are generally non-treatment related. Informed consent, patient education, and professional training are crucial for safe and successful outcomes. Level of Evidence II This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

摘要

背景

透明质酸(HA)真皮填充剂广泛应用于美容医学。虽然一般来说是安全的,但也可能出现潜在的并发症。

目的

本系统评价旨在通过高质量、低偏倚风险的研究,确定并分类与使用 HA 真皮填充剂相关的潜在并发症。

方法

本综述遵循 Cochrane 临床系统评价标准。本系统评价分析了 48 项关于非手术面部美容中使用透明质酸(HA)真皮填充剂及其不良反应的高水平证据研究。纳入标准为 HA 真皮填充剂及其并发症的随机对照研究。排除了病例报告、病例系列、观察性研究和其他非随机研究,因为它们无法提供普遍结论,并且存在固有发表偏倚。

结果

不良反应分为三类:预期反应、产品或技术相关不良反应和严重不良反应。大多数不良反应是短暂的注射部位反应,可自行消退。特定的 HA 填充物和注射技术影响不良反应的发生,这些不良反应通常在数周内无需治疗即可消退。严重不良反应罕见,持续数月,需要积极的医疗干预。

讨论

该分类系统可增强对 HA 填充剂并发症的理解、预防和治疗,并支持患者教育。常见的并发症是注射部位反应,使用局部类固醇、非甾体抗炎药或透明质酸酶治疗持续症状。严重的并发症包括严重水肿、血管性水肿等,通常需要特定的治疗。

结论

HA 真皮填充剂通常是安全有效的,大多数不良反应是短暂的,且严重程度为轻度至中度。严重不良反应虽然罕见,但确实会发生,且通常与治疗无关。知情同意、患者教育和专业培训对于安全和成功的结果至关重要。证据等级 II 本期刊要求作者为每篇文章指定一个证据等级。如需详细了解这些循证医学评级,请参考目录或在线作者指南 www.springer.com/00266

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