Objective: Severe cutaneous adverse reactions (SCARs) cause clinical and healthcare burdens all over the world. The purpose of this study is to analyze clinical manifestations of drug-related SCARs in order to reduce the risk and improve patient safety.

Methods: We retrospectively analyzed the records of adult patients (age ≥ 20 years old) who were admitted due to cutaneous adverse reactions from electronic medical record data and the Adverse Drug Reactions Reporting System database between July 2011 and January 2022 from a single medical center in Taiwan. The aforementioned cases are the SCARs cases defined in our study.

Results: The mean age of the 97 cases satisfying the inclusion criteria was 63.68 (SD = 18.62) years [range 20–96], 56 were female patients (57.7%). The SCARs cases that meet the definition of our study include 63 cases of maculopapular exanthema (MPE), but there were further analyses of the other 18 cases of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), 7 cases of drug reactions with eosinophilia and systemic symptoms (DRESS), 2 cases of acute generalized exanthematous pustulosis (AGEP), 5 cases of erythema multiforme (EM), major, and 2 cases of fixed drug eruption (FDE). According to Anatomical Therapeutic Chemical classification, antibacterials for systemic use was the most commonly implicated drug class (54.2%) and flomoxef was the most frequently reported as a causative drug. Compared to MPE and FDE, patients admitted with the diagnosis of SJS, TEN, DRESS, AGEP, or EM were more likely longer

in the length of hospital stays.

Conclusions: Compared with mild MPE or more localized FDE, SCARs cases of systemic or more severe form of cutaneous adverse reactions manifested with a higher frequency of fever, leukocytosis, blister, and mucositis. Our study highlighted the importance of awareness of some drugs at high risk of SCARs, particularly antibiotics for systemic use, such as flomoxef should be used more cautiously. In clinical practice, if the diagnosis and the causative drug could prompt identification, immediate withdrawal of all suspected ones and treatment appropriately, which may mitigate the negative impacts and improve clinical outcomes.

 

目的：嚴重皮膚不良反應 (severe cutaneous adverse reactions, SCARs) 在全球造成臨床醫療和健康照護的沈重負擔，本研究目的藉由分析藥品相關的嚴重皮膚不良反應案例型態，以期減低不良反應發生風險並提升病人用藥安全。

方法：本研究定義的SCARs 案例為經電子病歷資料和藥品不良反應通報系統資料庫，回顧性分析台灣某醫學中心2011 年7 月至2022 年1 月期間因皮膚不良反應住院的成年病人（年齡 ≥ 20 歲）的醫療資訊。

結果：符合研究納入條件的97 位案例，平均年齡為63.68 歲（標準差18.62）[ 範圍20–96]，女性有56 例（占57.7%）；符合我們研究定義的SCARs 住院案例包括63 例紅斑丘疹輕症 (MPE)，其他18 例史蒂文生氏強生症候群或毒性表皮壞死溶解症 (Stevens-Johnson syndrome /toxic epidermal necrolysis, SJS/TEN)，7 例藥物疹合併嗜伊紅性白血球症與全身症狀 (drug reactions with eosinophilia and systemic symptoms, DRESS)，2 例急性廣泛性發疹性膿皰症 (acute generalized exanthematous pustulosis, AGEP)，5 例多形性紅斑 (erythema multiforme, EM) 重型，以及2 例固定型藥疹 (fixed drug eruption, FDE) 有進一步分析臨床特徵；肇因藥品類別依據解剖學治療學及化學分類系統分類，以全身性使用之抗生素占最多數 (54.2%)，而flomoxef為最常見的可疑藥品成分；另分析個案住院時間， 診斷為SJS、TEN、DRESS、AGEP 或EM 的患者相較於MPE 和FDE 的患者，有較長的住院時間。

結論：相較於紅斑丘疹輕症或固定型藥疹，全身症狀表現的SCARs 案例，有較高的頻率出現發燒、白血球增多、皮膚水疱和黏膜損傷。我們的研究發現對有高風險可能引起嚴重皮膚不良反應的藥品要有警覺的重要性，特別是全身性使用之抗生素，如：flomoxef 用藥時應更加注意。臨床上若能即時確立診斷，並辨識肇因藥品儘早停用所有相關的可疑藥品及適當地治療，或可降低不良反應造成的負面影響改善預後。

 

 

Submitted for publication: 2023.9.28; Accepted for publication: 2024.3.14