Abstract：
UNASSIGNED: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) are potentially life-threatening severe cutaneous adverse reactions (SCARs). Although the classical causal agents of SCARs (antibiotics, anticonvulsants, nonsteroidal anti-inflammatory drugs, and allopurinol) are well characterized, there has been little update to this list to account for newly marketed medications.
UNASSIGNED: To provide an updated and stratified list of medications with significant reporting odds ratios (RORs) of SCARs.
UNASSIGNED: A case/non-case analysis using the United States FDA Adverse Event Reporting System was performed.
UNASSIGNED: As expected, the prototypical medication classes made up the majority of reported cases of SJS, TEN, AGEP, and DRESS (77%, 64%, 75%, and 72%, respectively). In addition, several infrequently or previously undescribed classes/medications implicated in SCARs were identified to have significant ROR signals, including acetylcysteine, anticoagulants, diuretics, immunotherapies, proton pump inhibitors, antivirals, and antifungals. Among these reported for SJS were acetylcysteine (ROR: 64.38) and fluconazole (ROR: 17.13). For TEN, we identified furosemide (ROR: 26.32), spironolactone (ROR: 14.45), fluconazole (ROR: 30.21), amphotericin B (39.06), and acetylcysteine (ROR: 93.12). For AGEP, we identified acyclovir (ROR: 61.72), valacyclovir (ROR: 30.76), and enoxaparin (ROR: 27.37). For DRESS, we identified vemurafenib (ROR: 17.35), acyclovir (ROR: 30.63), abacavir (ROR: 26.62), raltegravir (ROR: 23.27), and valacyclovir (ROR: 21.77) to have strong reporting odds.
UNASSIGNED: Our analysis provides an updated tool for physicians to reference when identifying suspected SCARs and a basis for future studies to investigate atypical medication causality.
UNASSIGNED: To provide an updated and stratified list of medications with significant reporting odds ratios (RORs) of SCARs.
UNASSIGNED: A case/non-case analysis using the United States FDA Adverse Event Reporting System was performed.
UNASSIGNED: As expected, the prototypical medication classes made up the majority of reported cases of SJS, TEN, AGEP, and DRESS (77%, 64%, 75%, and 72%, respectively). In addition, several infrequently or previously undescribed classes/medications implicated in SCARs were identified to have significant ROR signals, including acetylcysteine, anticoagulants, diuretics, immunotherapies, proton pump inhibitors, antivirals, and antifungals. Among these reported for SJS were acetylcysteine (ROR: 64.38) and fluconazole (ROR: 17.13). For TEN, we identified furosemide (ROR: 26.32), spironolactone (ROR: 14.45), fluconazole (ROR: 30.21), amphotericin B (39.06), and acetylcysteine (ROR: 93.12). For AGEP, we identified acyclovir (ROR: 61.72), valacyclovir (ROR: 30.76), and enoxaparin (ROR: 27.37). For DRESS, we identified vemurafenib (ROR: 17.35), acyclovir (ROR: 30.63), abacavir (ROR: 26.62), raltegravir (ROR: 23.27), and valacyclovir (ROR: 21.77) to have strong reporting odds.
UNASSIGNED: Our analysis provides an updated tool for physicians to reference when identifying suspected SCARs and a basis for future studies to investigate atypical medication causality.
摘要：
■史蒂文斯-约翰逊综合征（SJS），中毒性表皮坏死松解症（TEN），嗜酸粒细胞增多和全身症状的药物反应（DRESS），急性泛发性发疹性脓疱病(AGEP)是潜在危及生命的严重皮肤不良反应(SCAR).虽然SCAR的经典病原体(抗生素，抗惊厥药,非甾体抗炎药，和别嘌呤醇)的特征很好，对于新上市的药物，这份清单几乎没有更新。
■提供具有显著SCAR报告优势比（ROR）的药物的更新和分层列表。
■使用美国FDA不良事件报告系统进行病例/非病例分析。
■如预期的那样，典型的药物治疗类别占SJS报告病例的大多数，十,AGEP,和连衣裙(77%，64%,75%,72%,分别)。此外,与SCAR有关的几种罕见或以前未描述的类别/药物被鉴定为具有显着的ROR信号，包括乙酰半胱氨酸,抗凝剂,利尿剂,免疫疗法，质子泵抑制剂,抗病毒药物,和抗真菌药。SJS报道的这些是乙酰半胱氨酸(ROR:64.38)和氟康唑(ROR:17.13)。对于十个，我们确定了呋塞米（ROR：26.32），螺内酯（ROR：14.45），氟康唑（ROR：30.21），两性霉素B(39.06),和乙酰半胱氨酸(ROR:93.12)。对于AGEP，我们确定了阿昔洛韦（ROR：61.72），伐昔洛韦（ROR：30.76），和依诺肝素（ROR：27.37）。对于连衣裙，我们确定了vemurafenib（ROR：17.35），阿昔洛韦（ROR：30.63），阿巴卡韦（ROR：26.62），拉特格韦（ROR：23.27），和伐昔洛韦（ROR：21.77）具有很强的报告几率。
■我们的分析提供了一个更新的工具，供医生在识别可疑SCAR时参考，并为将来研究非典型药物因果关系提供了基础。
■提供具有显著SCAR报告优势比（ROR）的药物的更新和分层列表。
■使用美国FDA不良事件报告系统进行病例/非病例分析。
■如预期的那样，典型的药物治疗类别占SJS报告病例的大多数，十,AGEP,和连衣裙(77%，64%,75%,72%,分别)。此外,与SCAR有关的几种罕见或以前未描述的类别/药物被鉴定为具有显着的ROR信号，包括乙酰半胱氨酸,抗凝剂,利尿剂,免疫疗法，质子泵抑制剂,抗病毒药物,和抗真菌药。SJS报道的这些是乙酰半胱氨酸(ROR:64.38)和氟康唑(ROR:17.13)。对于十个，我们确定了呋塞米（ROR：26.32），螺内酯（ROR：14.45），氟康唑（ROR：30.21），两性霉素B(39.06),和乙酰半胱氨酸(ROR:93.12)。对于AGEP，我们确定了阿昔洛韦（ROR：61.72），伐昔洛韦（ROR：30.76），和依诺肝素（ROR：27.37）。对于连衣裙，我们确定了vemurafenib（ROR：17.35），阿昔洛韦（ROR：30.63），阿巴卡韦（ROR：26.62），拉特格韦（ROR：23.27），和伐昔洛韦（ROR：21.77）具有很强的报告几率。
■我们的分析提供了一个更新的工具，供医生在识别可疑SCAR时参考，并为将来研究非典型药物因果关系提供了基础。
