Dermatology Department, Habib Thameur Hospital, 1089 Tunis, Tunisia.
National Center of Pharmacovigilance, 1002 Tunis, Tunisia.
Therapie. 2019 Oct;74(5):527-530. doi: 10.1016/j.therap.2019.01.009. Epub 2019 Mar 31.
Bullous fixed drug eruption (BFDE) is a rare and particular adverse drug reaction characterized by localized or generalized blisters and erosions, which can be confused with Stevens-Johnson syndrome, toxic epidermal necrolysis, major erythema multiforme and autoimmune bullous dermatosis.
The aim of our study was to assess the epidemiological, clinical and therapeutic features and outcome of BFDE.
A retrospective and descriptive study collecting all observations of BFDE was conducted in the dermatology department of Habib Thameur Hospital in Tunisia, over an 18-year period (2000-2017). The diagnosis of BFDE was confirmed by histopathological examination and all the patients underwent pharmacovigilance investigation.
Totally, 18 cases were enrolled in our study with BFDE. The mean age was 57.9 years with a sex ratio M/F of 1. BFDE was localized in 8 cases and generalized in 10 cases. It was the first episode of BFDE in 11 patients and a recurrence in 7 patients. Drugs involved in the genesis of BFDE in our study were mainly non-steroidal anti-inflammatory drugs in 10 patients and antibiotics in 5 cases. Drug patch tests were performed in four patients on the residual plaques of FDE (fixed drug eruption) and were positive to the suspected drug. A favorable outcome was observed in all our patients under treatment and after suspected drug withdrawal.
BFDE is a rare adverse drug reaction and could be severe especially when it presents as a generalized eruption. Drugs involved are mainly non-steroidal anti-inflammatory drugs followed by antibiotics.
大疱性固定性药物疹（BFDE）是一种罕见且特殊的药物不良反应，其特征为局部或全身性水疱和糜烂，易与史蒂文斯-约翰逊综合征、中毒性表皮坏死松解症、大疱性多形红斑和自身免疫性大疱性皮肤病相混淆。
本研究旨在评估 BFDE 的流行病学、临床和治疗特征及结局。
在突尼斯哈比卜·图迈尔医院皮肤科进行了一项回顾性描述性研究，收集了 18 年来（2000-2017 年）所有 BFDE 观察病例。通过组织病理学检查确诊 BFDE，所有患者均进行了药物警戒调查。
本研究共纳入 18 例 BFDE 患者。平均年龄为 57.9 岁，男女比例为 1:1。BFDE 局部性 8 例，全身性 10 例。11 例为首次发病，7 例为复发。本研究中导致 BFDE 的药物主要为非甾体类抗炎药 10 例，抗生素 5 例。对 FDE（固定性药物疹）残留斑块进行 4 例药物斑贴试验，均对可疑药物呈阳性。所有患者经治疗和可疑药物停用后均获得良好结局。
BFDE 是一种罕见的药物不良反应，尤其是全身性发作时可能较为严重。涉及的药物主要是非甾体类抗炎药，其次是抗生素。
