School of Medicine, 3989Baylor College of Medicine, Houston, TX, USA.
Department of Dermatology, 4002The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Phlebology. 2022 Jul;37(6):452-459. doi: 10.1177/02683555221088373. Epub 2022 Apr 20.
To analyze adverse events (AEs) related to sclerosants reported through the Federal Adverse Event Reporting System (FAERS).
We queried the FAERS database for all cases associated with sclerosants. Reports were analyzed and stratified based on severity of cases and patient death.
A total of 1215 cases with 3124 reactions were identified among 4 sclerosants. "General disorder and administration site conditions" reaction group was prevalent in all sclerosants. For polidocanol, deep vein thrombosis and pulmonary embolism were the most common severe reactions while cardiac arrest was frequent in death cases. Anaphylaxis was common in fatalities of sodium tetradecyl sulfate. Ethanolamine oleate was associated with procedural errors, while morrhuate sodium resulted in few cases.
Our analysis supports previous studies concerning common local symptoms, but also reveals serious and death associated reaction profiles specific to individual sclerosants. Practitioners should be knowledgeable on both non-lethal and fatal AEs for each sclerosant. The multitude of reports concerning serious reactions and deaths we report herein provide a cautionary reminder to venous practitioners and patients that sclerotherapy is not a trivial procedure.
通过联邦不良事件报告系统（FAERS）分析与硬化剂相关的不良事件（AE）。
我们在 FAERS 数据库中查询了所有与硬化剂相关的病例。根据病例的严重程度和患者死亡情况对报告进行了分析和分层。
在 4 种硬化剂中，共发现 1215 例 3124 种反应。“一般紊乱和给药部位情况”反应组在所有硬化剂中均较为常见。对于聚多卡醇，深静脉血栓形成和肺栓塞是最常见的严重反应，而心脏骤停在死亡病例中较为常见。在硫酸十四烷基钠的死亡病例中，过敏反应较为常见。乙醇酸油酸与操作失误有关，而马尿酸钠则导致较少的病例。
我们的分析支持先前关于常见局部症状的研究，但也揭示了特定于个别硬化剂的严重和致死相关反应特征。从业者应该了解每种硬化剂的非致死性和致死性 AE。我们在此报告的大量关于严重反应和死亡的报告，提醒静脉治疗师和患者，硬化疗法并非微不足道的程序。
