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回顾性分析 4500 例接受 20mg/ml 平滑、高凝聚力透明质酸填充剂治疗后迟发性不良反应的病例。

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients.

机构信息

Department of Dermatology, University of British Columbia, Vancouver, British Columbia, Canada.

Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California.

出版信息

J Am Acad Dermatol. 2020 Jul;83(1):86-95. doi: 10.1016/j.jaad.2020.01.066. Epub 2020 Feb 6.

DOI:10.1016/j.jaad.2020.01.066
PMID:32035107
Abstract

BACKGROUND

Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V).

OBJECTIVE

To examine the occurrence of HA-V DAEs and identify patterns and characteristics.

METHODS

Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed.

RESULTS

In 4500 patients who received 9324 treatments with HA-V, 44 DAEs were identified, for a combined incidence of 0.98% per patient, 0.47% per treatment, and 0.23% per syringe. Patients with DAEs received a slightly larger cumulative amount of HA-V than those who did not. Delayed swelling and nodule formation were the most common reactions and occurred a median of 4 months after treatment, with an increase in frequency between October and January. About a third were preceded by an identifiable immunologic stimulus. DAEs were transient and resolved without incident.

LIMITATIONS

The retrospective nature made it difficult to capture time to resolution or remember potential triggers.

CONCLUSION

In this large, long-term, retrospective review, HA-V DAEs occurred at a rate of 0.98% per patient. Although the exact cause has yet to be elucidated, we hypothesize that an increase in fragmentation during the HA-V degradation process may trigger an inflammatory response after an immunologic trigger.

摘要

背景

最近的研究表明,使用平滑、均匀的 20mg/ml 透明质酸填充剂 Juvederm Voluma(HA-V)可能会增加迟发性不良反应(DAE)的风险。

目的

研究 HA-V 的 DAE 发生情况,并确定其发生模式和特征。

方法

对 2009 年 2 月 1 日至 2018 年 2 月 28 日期间在 2 家诊所接受 HA-V 治疗的患者的图表进行了分析。

结果

在 4500 名接受了 9324 次 HA-V 治疗的患者中,发现了 44 例 DAE,患者的合并发生率为 0.98%,治疗的发生率为 0.47%,注射器的发生率为 0.23%。发生 DAE 的患者接受的 HA-V 累积量略多于未发生 DAE 的患者。迟发性肿胀和结节形成是最常见的反应,中位发生时间为治疗后 4 个月,10 月至 1 月之间的发生率增加。约三分之一的患者之前存在可识别的免疫刺激。DAE 是短暂的,没有发生不良事件。

局限性

回顾性研究难以捕捉到解决时间或记忆潜在的触发因素。

结论

在这项大规模、长期、回顾性研究中,HA-V 的 DAE 发生率为 0.98%。虽然确切原因尚未阐明,但我们假设 HA-V 降解过程中碎片增加可能在免疫刺激后引发炎症反应。

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