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不同注射填充剂的风险概况:注射填充剂安全性研究(IFS研究)结果

Risk profiles of different injectable fillers: results from the Injectable Filler Safety Study (IFS Study).

作者信息

Zielke Hendrik, Wölber Linn, Wiest Luitgard, Rzany Berthold

机构信息

Division of Evidence-Based Medicine (dEBM), Department of Dermatology, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.

出版信息

Dermatol Surg. 2008 Mar;34(3):326-35; discussion 335. doi: 10.1111/j.1524-4725.2007.34066.x. Epub 2007 Dec 20.

DOI:10.1111/j.1524-4725.2007.34066.x
PMID:18177399
Abstract

BACKGROUND

Injectable fillers are widely used in aesthetic medicine. Although most materials are considered to be safe, adverse events occur. Our knowledge on frequency and potential risk factors is limited.

OBJECTIVE

The aim of this study was to describe adverse reactions to injectable fillers based on a partly population-based case series.

METHODS

Dermatologists, plastic surgeons, and maxillofacial surgeons in Berlin were asked to report patients with adverse reactions. Additional patients were obtained from a private practice. A standardized questionnaire was used to assess all data. All data were analyzed by descriptive measures.

RESULTS

Fifty-six patients (age, 48+/-11.2 (SD) years) who had been treated with nine different fillers were assessed. In 48 patients treated with only one filler, 167 areas had been treated. In 129 (77.3%) areas adverse reactions occurred 12.2+/-15.6 (SD) months after injection. Adverse reactions to biodegradable fillers occurred after 4.9+/-5.8 (SD) months, and reactions to nonbiodegradable fillers after 18.3+/-19.0 (SD) months (p=.005). As adverse events, continuing pain, swelling, nodules, pigmentation, abscess formation, and erythema were found.

CONCLUSION

Adverse reactions can be documented for all injectable fillers. Time until reaction as well as type of reaction, however, vary between different fillers. Further research is necessary to evaluate potential risk factors.

摘要

背景

可注射填充剂在美容医学中广泛应用。尽管大多数材料被认为是安全的,但仍会发生不良事件。我们对其发生频率和潜在风险因素的了解有限。

目的

本研究旨在基于部分基于人群的病例系列描述可注射填充剂的不良反应。

方法

要求柏林的皮肤科医生、整形外科医生和颌面外科医生报告有不良反应的患者。另外的患者来自一家私人诊所。使用标准化问卷评估所有数据。所有数据通过描述性方法进行分析。

结果

评估了56例接受9种不同填充剂治疗的患者(年龄48±11.2(标准差)岁)。在仅接受一种填充剂治疗的48例患者中,共治疗了167个部位。其中129个(77.3%)部位在注射后12.2±15.6(标准差)个月出现不良反应。可生物降解填充剂的不良反应在4.9±5.8(标准差)个月后出现,不可生物降解填充剂的不良反应在18.3±19.0(标准差)个月后出现(p = 0.005)。发现的不良事件包括持续疼痛、肿胀、结节、色素沉着、脓肿形成和红斑。

结论

所有可注射填充剂均可记录到不良反应。然而,不同填充剂出现反应的时间以及反应类型各不相同。有必要进一步研究以评估潜在风险因素。

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