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静脉密封剂(VenaSeal)氰基丙烯酸酯治疗浅静脉功能不全后患者发生超敏反应的频率和严重程度。

Frequency and severity of hypersensitivity reactions in patients after VenaSeal™ cyanoacrylate treatment of superficial venous insufficiency.

机构信息

Lake Washington Vascular Surgeons, Bellevue, USA.

出版信息

Phlebology. 2020 Jun;35(5):337-344. doi: 10.1177/0268355519878618. Epub 2019 Sep 25.

DOI:10.1177/0268355519878618
PMID:31554473
Abstract

OBJECTIVE

Hypersensitivity reaction presenting as a distinctive erythematous rash has been reported following VenaSeal™ cyanoacrylate adhesive closure. We report the frequency of hypersensitivity reactions, time to onset, duration, and severity of symptoms in patients treated with cyanoacrylate adhesive closure at a single institution. Patient and procedural factors associated with hypersensitivity reactions were evaluated.

METHODS

A combined retrospective/prospective review of cyanoacrylate adhesive closure-treated patients was conducted over five years. Data collected from electronic medical records were reviewed for the presence of hypersensitivity reactions along with the time of onset, duration of symptoms, and severity of reaction. Severity was classified as mild if no treatment or over the counter medication was provided, moderate if steroids were required, and severe if the reaction lasted >30 days or required vein excision.

RESULTS

Three hundred and seventy-nine limbs were treated in 286 patients (313 treatment days). Hypersensitivity reactions occurred in 18 patients (5.8% treatments, 6.3% patients). Thirteen were mild (4.2%), four were moderate (1.3%), and one was severe (0.3%). No patient or procedural predictive factors for hypersensitivity reaction were identified other than a trend towards decreased hypersensitivity reactions in patients with Clinical, Etiologic, Anatomic, Pathophysiologic (CEAP) clinical class C4-C6 (p = .06). Second limb treatment on a subsequent day was performed in 27 patients, and no hypersensitivity reactions occurred. Symptom onset time ranged from 1 to 23 days, with a mean of 13 days (confidence interval (CI) ±3.5 days). Duration of symptoms ranged from 3 to 28 days (mean 10.8 CI ±4.9 days).

CONCLUSIONS

Hypersensitivity reactions occurred in 6.0% of patients treated with cyanoacrylate adhesive closure, but most were mild and self-limited. Severe reactions were uncommon. No predictive patient or procedural factors were found to be associated with hypersensitivity reactions other than a trend towards decreased risk in patients with advanced CEAP clinical class. Previous cyanoacrylate adhesive closure treatment was not a predictive factor for hypersensitivity reaction in patients undergoing treatment at a later date.

摘要

目的

已有报道称,使用 VenaSeal™氰基丙烯酸酯胶粘剂封闭后会出现表现为独特红斑疹的过敏反应。我们报告在单一机构接受氰基丙烯酸酯胶粘剂封闭治疗的患者中过敏反应的频率、发病时间、持续时间和症状严重程度。评估了与过敏反应相关的患者和程序因素。

方法

对 5 年内接受氰基丙烯酸酯胶粘剂封闭治疗的患者进行了回顾性/前瞻性联合研究。从电子病历中收集数据,以评估过敏反应的存在以及发病时间、症状持续时间和反应严重程度。如果不需要治疗或使用非处方药物,则将严重程度分类为轻度;如果需要使用类固醇,则为中度;如果反应持续时间>30 天或需要切除静脉,则为重度。

结果

379 条肢体在 286 名患者(313 个治疗日)中接受了治疗。18 名患者(5.8%的治疗,6.3%的患者)出现过敏反应。其中 13 例为轻度(4.2%),4 例为中度(1.3%),1 例为重度(0.3%)。除了临床、病因、解剖、病理生理(CEAP)临床 C4-C6 级患者过敏反应趋势减少(p=0.06)外,未发现其他患者或程序预测过敏反应的因素。在 27 名随后一天接受第二肢体治疗的患者中,未发生过敏反应。症状发作时间为 1 至 23 天,平均为 13 天(置信区间(CI)±3.5 天)。症状持续时间为 3 至 28 天(平均 10.8 CI±4.9 天)。

结论

在接受氰基丙烯酸酯胶粘剂封闭治疗的患者中,过敏反应发生率为 6.0%,但大多数为轻度且自限性。严重反应并不常见。除了 CEAP 临床 C 级晚期患者风险降低的趋势外,未发现与过敏反应相关的预测性患者或程序因素。在随后的日期接受治疗的患者中,先前接受氰基丙烯酸酯胶粘剂封闭治疗不是过敏反应的预测因素。

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