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去氧胆酸注射用于颏下和面颊部脂肪减少后的严重不良事件管理:一项系统评价与管理建议

Management of Serious Adverse Events Following Deoxycholic Acid Injection for Submental and Jowl Fat Reduction: A Systematic Review and Management Recommendations.

作者信息

Shridharani Sachin M, Kennedy MacKenzie L

出版信息

Aesthet Surg J Open Forum. 2024 Aug 13;6:ojae061. doi: 10.1093/asjof/ojae061. eCollection 2024.

Abstract

Pivotal Phase 3 randomized control trials have demonstrated a favorable safety profile for ATX-101 in submental fat (SMF) reduction; however, in real-world settings, several serious adverse events (SAEs) have been reported, most of which are procedure related and avoidable. Current understanding of the management of uncommon AEs and SAEs is based on the aesthetic surgeon's discretion, and overzealous protocols for sclerosis agents are being applied for ATX-101-induced arterial injury. This review focuses on showcasing the management of SAEs reported previously and updating it with personal clinical experiences with ATX-101 for SMF and jowl fat reduction. Along with adherence to the standard procedures for ATX-101 administration, the authors recommend investigating other potential causes of SMF accumulation and jowling mechanism, appropriate demarcation of the surface area to determine the number of vials, and assessment of the fat pad thickness to determine the number of required treatment cycles for optimal therapeutic outcomes. Surgery is preferable for jowling caused by compartment displacement (ptosis), whereas fat-reducing treatments such as ATX-101 are contraindicated for jowling caused by subcutaneous tissue atrophy. Some proactive measures that can be employed to prevent AEs include avoiding intradermal injections to prevent skin ulceration/necrosis, injecting lidocaine to check for smile asymmetry as an indication of marginal mandibular nerve proximity, administering 1 to 2 mm deeper injections in males to prevent alopecia, employing good aseptic techniques to prevent abscess formation, injecting 1 product at a time using correctly labeled syringes, and confirming the diagnosis of pyoderma gangrenosum before treating it as an infection.

摘要

关键的3期随机对照试验已证明ATX - 101在减少颏下脂肪(SMF)方面具有良好的安全性;然而,在实际应用中,已报告了几起严重不良事件(SAE),其中大多数与操作相关且是可避免的。目前对于罕见不良事件和严重不良事件管理的认识基于美容外科医生的判断,并且针对ATX - 101引起的动脉损伤,正在应用过于严格的硬化剂方案。本综述重点展示先前报告的严重不良事件的管理,并结合作者使用ATX - 101减少SMF和颊脂垫的个人临床经验进行更新。除了遵守ATX - 101给药的标准程序外,作者建议研究SMF积累和颊部下垂机制的其他潜在原因,适当划分表面积以确定药瓶数量,以及评估脂肪垫厚度以确定获得最佳治疗效果所需的治疗周期数。对于由隔室移位(下垂)引起的颊部下垂,手术是更可取的,而对于由皮下组织萎缩引起的颊部下垂,诸如ATX - 101之类的减脂治疗是禁忌的。一些可用于预防不良事件的积极措施包括避免皮内注射以防止皮肤溃疡/坏死,注射利多卡因以检查微笑不对称作为下颌缘神经接近的指标,男性注射时深度增加1至2毫米以防止脱发,采用良好的无菌技术以防止脓肿形成,每次使用正确标记的注射器注射一种产品,以及在将坏疽性脓皮病当作感染治疗之前确认诊断。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4570/11381091/4d5b54d6eaa3/ojae061f1.jpg

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