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基于甲基丙烯酸羟乙酯和甲基丙烯酸乙酯与透明质酸的固定组合的注射用填充剂发生严重不良反应的风险。

Risk of severe adverse reactions to an injectable filler based on a fixed combination of hydroxyethylmethacrylate and ethylmethacrylate with hyaluronic acid.

作者信息

Rossner Mathias, Rossner Florian, Bachmann Frank, Wiest Luitgard, Rzany Berthold

机构信息

Division of Evidence Based Medicine, Department of Dermatology, Charité Universitätsmedizin Berlin, Berlin, Germany.

出版信息

Dermatol Surg. 2009 Feb;35 Suppl 1:367-74. doi: 10.1111/j.1524-4725.2008.01062.x.

DOI:10.1111/j.1524-4725.2008.01062.x
PMID:19207327
Abstract

BACKGROUND

Hydroxyethylmethacrylate and ethylmethacrylate in a fixed combination with hyaluronic acid has been used as an injectable filler for nearly a decade. Severe adverse reactions have been associated with this filler.

OBJECTIVE

To characterize the adverse reactions to this filler.

METHODS

Data from the Berlin registry for adverse reactions to injectable fillers were analyzed. The registry is a partially population-based registry with the aim of collecting adverse reactions to injectable fillers. Patients were interviewed based on a standardized questionnaire.

RESULTS

Thirty-four of 118 (28.8%) registered patients were treated with this filler. Of 95 treated areas, 87 responded with a reaction (91.6%). The most frequently observed adverse events were the development of nodules (n=85) in 87 affected areas, discoloration (n=39), erythema or inflammation (n=32), and swelling (n=24). Most nodular reactions were rated as severe. The mean time after the last treatment until appearance of an adverse reaction was 23.1+/-22.8 months.

CONCLUSION

Adverse reactions to this methacrylate filler are common. The mean latency period for these mostly severe rated reactions was nearly 2 years. Based on the frequency and severity of these reactions, the use of this filler does not seem to be advisable.

摘要

背景

甲基丙烯酸羟乙酯和甲基丙烯酸乙酯与透明质酸的固定组合已作为可注射填充剂使用了近十年。这种填充剂与严重的不良反应有关。

目的

描述对这种填充剂的不良反应。

方法

分析了柏林可注射填充剂不良反应登记处的数据。该登记处是一个部分基于人群的登记处,旨在收集可注射填充剂的不良反应。根据标准化问卷对患者进行访谈。

结果

118名登记患者中有34名(28.8%)接受了这种填充剂治疗。在95个治疗区域中,87个出现了反应(91.6%)。最常观察到的不良事件是87个受影响区域出现结节(n = 85)、变色(n = 39)、红斑或炎症(n = 32)以及肿胀(n = 24)。大多数结节反应被评为严重。最后一次治疗至出现不良反应的平均时间为23.1±22.8个月。

结论

这种甲基丙烯酸酯填充剂的不良反应很常见。这些大多为严重程度的反应的平均潜伏期接近2年。基于这些反应的频率和严重程度,使用这种填充剂似乎不可取。

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