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面部真皮填充剂注射与接种疫苗:不良事件报告和文献回顾的 12 年回顾。

Facial Dermal Filler Injection and Vaccination: A 12-Year Review of Adverse Event Reporting and Literature Review.

出版信息

Aesthet Surg J. 2023 Jun 14;43(7):NP544-NP557. doi: 10.1093/asj/sjad031.

Abstract

BACKGROUND

Following authorization of 2 COVID-19 vaccines in December 2020, media attention increased towards postvaccine adverse events (AEs) in patients with facial dermal filler injections.

OBJECTIVES

The purpose of this study was to characterize vaccine-related facial dermal filler AEs by scrutinizing the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

METHODS

The MAUDE database was queried from January 1, 2011 to January 28, 2023 for facial dermal filler medical device reports (MDRs) discussing vaccination-related AEs. A PubMed (National Institutes of Health, Bethesda, MD) literature review on dermal filler AEs was then conducted. Data were analyzed with descriptive statistics.

RESULTS

Of 10,637 MDRs identified, 33 were included. There were 25 MDRs (75.8%) related to COVID-19 vaccination. Hyaluronic acid-based fillers were described in 31 MDRs (93.9%). AEs were mostly reported within days postinjection (n = 7, 21.2%), but ranged from immediately (n = 2, 6.1%) to months (n = 6, 18.2%) postinjection. Most AEs were reported postvaccine (n = 17, 51.5%) vs postfiller (n = 14, 42.4%). In 26 reports (78.8%), AEs occurred at the site of filler injection. Most MDRs described inflammation/swelling (n = 21, 28.0%). The literature review returned 302 articles, of which 14 were included. Only 1 article (7.1%) was published in a plastic surgery journal.

CONCLUSIONS

Although the pandemic brought attention to COVID-19 vaccine-related facial dermal filler AEs, this study shows a low incidence compared with the millions of vaccine and filler injections administered. Reactions with non-COVID-19 vaccines were also documented. Increased awareness may help providers counsel patients undergoing vaccination and dermal filler implantation.

摘要

背景

2020 年 12 月,两款 COVID-19 疫苗获得批准后,媒体对接受过面部真皮填充注射的患者的疫苗后不良反应(AE)的关注度增加。

目的

本研究的目的是通过仔细研究 FDA 的制造商和用户设施设备体验(MAUDE)数据库,描述与疫苗相关的面部真皮填充剂 AE。

方法

从 2011 年 1 月 1 日至 2023 年 1 月 28 日,在 MAUDE 数据库中查询了与疫苗相关 AE 的面部真皮填充医疗器械报告(MDR)。然后对真皮填充剂 AE 的 PubMed(美国国立卫生研究院,贝塞斯达,MD)文献进行了综述。使用描述性统计对数据进行了分析。

结果

在确定的 10637 份 MDR 中,有 33 份被纳入。其中 25 份(75.8%)与 COVID-19 疫苗接种相关。31 份 MDR 报告(93.9%)与透明质酸基填充物有关。AE 主要在注射后数天内报告(n=7,21.2%),但范围从即刻(n=2,6.1%)到数月(n=6,18.2%)。大多数 AE 在疫苗接种后报告(n=17,51.5%),而非填充剂(n=14,42.4%)。在 26 份报告(78.8%)中,AE 发生在填充剂注射部位。大多数 MDR 描述了炎症/肿胀(n=21,28.0%)。文献综述返回了 302 篇文章,其中 14 篇被纳入。在发表的文章中,只有 1 篇(7.1%)发表在整形外科学杂志上。

结论

尽管大流行引起了对 COVID-19 疫苗相关面部真皮填充剂 AE 的关注,但与接种的数百万支疫苗和填充剂相比,本研究显示发病率较低。还记录了与非 COVID-19 疫苗相关的反应。提高认识可能有助于提供者为接受疫苗接种和真皮填充植入的患者提供咨询。

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