The Spectrum of Adverse Reactions After Treatment with Injectable Fillers in the Glabellar Region: Results from the Injectable Filler Safety Study
The Spectrum of Adverse Reactions After Treatment with Injectable Fillers in the Glabellar Region: Results from the Injectable Filler Safety Study
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DOI：
10.1111/j.1524-4725.2009.01341.x
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发表时间：
2009-10-01
影响因子：
2.4
通讯作者：
Rzany, Berthold
中科院分区：
文献类型：
--
作者：
Bachmann, Frank;Erdmann, Ricardo;Rzany, Berthold
背景：对于眉间区，注射填充剂治疗后严重的部分血管不良事件已被报道。方法和材料：在本研究中，研究人员分析了来自可注射填充物安全性研究的数据，该研究是德国的一个关于这些反应的注册中心，以表征在额骨区看到的不良事件。对患者进行描述性分析。结果139例登记的患者中有40例报告了眉间区不良事件。所有患者均为女性，平均年龄52.3岁。报告甲基丙烯酸羟乙酯（HEMA）、甲基丙烯酸乙酯（EMA）与透明质酸（HA）固定联合用药不良反应19例，不同透明质酸产品不良反应10例；5例患者对聚l -乳酸（PLA）有反应。HA和PLA中HEMA/EMA最常见的不良反应是结节和硬化。在ha治疗的患者中，红斑、炎症、肿胀和疼痛最为常见。50%的HA患者出现严重的HEMA/EMA不良反应。用HA和PLA治疗的患者出现严重不良反应的程度较轻。仅有2例患者出现潜在的血管并发症。结论眉间不良反应绝大多数与产品相关，较小程度上与部位相关。血管并发症合并坏死和溃疡是罕见的。
BACKGROUND For the glabellar region, severe partly vascular adverse events have been reported after treatment with injectable fillers.METHODS AND MATERIALS For this study, data from the Injectable Filler Safety Study, a German-based registry for those reactions, was analyzed to characterize adverse events seen in the glabellar region. Patients were analyzed descriptively.RESULTS Forty of 139 registered patients reported adverse events in the glabellar region. All patients were female, with an average age of 52.3. Nineteen patients with adverse reactions to hydroxyethylmethacrylate (HEMA) and ethylmethacrylate (EMA) in a fixed combination with hyaluronic acid (HA) and 10 patients with adverse reactions to different hyaluronic acid products were reported; five patients reacted to poly-L-lactic acid (PLA). The most common adverse reactions to HEMA/EMA in HA and PLA were nodules and hardening. In HA-treated patients, erythema and inflammation, swelling, and pain were most frequent. The adverse reactions to HEMA/EMA in HA were severe in 50% of the patients. Severe adverse reactions were found to a lesser extent in patients treated with HA and PLA. Potential vascular complications were documented in only two patients.CONCLUSION Adverse reactions seen in the glabella are overwhelmingly product associated and to a lesser extent location associated. Vascular complications with necrosis and ulceration were rare.