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口服抗凝药物致严重皮肤不良反应的文献分析
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郑 爽 ，姜荣荣 ，朱建国 ，谢 诚 （1.苏州大学附属第一医院药学部，江苏 苏州 215006；2.苏州市中西医
1， 2
结合医院药剂科，江苏 苏州 215101）
中图分类号 R973+.2 文献标志码 A 文章编号 1001-0408（2025）12-1500-05
DOI 10.6039/j.issn.1001-0408.2025.12.14

摘 要 目的 分析口服抗凝药物（OACs）致严重皮肤不良反应（SCARs）的临床特征，为该类药物的临床安全应用提供参考。方法
以“口服抗凝药”“Ⅹa因子抑制剂”“直接凝血酶抑制剂”“oral anticoagulants”“factor Ⅹa inhibitor”“direct thrombin inhibitor”等为中
英文检索词，计算机检索PubMed、Embase、中国知网、万方数据、维普网等数据库，收集OACs（华法林、阿哌沙班、利伐沙班、艾多
沙班、达比加群酯）致SCARs的病例报道并进行描述性分析。结果 共纳入11篇文献，共计11例患者，其中男性5例（45.5%）、女性
6例（54.5%），平均年龄（59.6±21.5）岁；原患疾病主要为心房纤颤、肺栓塞、关节置换和瓣膜置换；涉及药物包括华法林（3例）、利
伐沙班（4例）、阿哌沙班（2例）、达比加群酯（2例）。OACs致SCARs发生在用药后10 h～42 d，其中发生在用药后10～28 d的有7
例（63.6%）。11例患者中，5例为伴嗜酸性粒细胞增多和系统症状的药物反应，4例为史-约综合征或中毒性表皮坏死松解症，2例
为急性泛发性发疹性脓疱病；临床表现包括皮疹、发热、黏膜受损等。除1例患者因败血症和弥散性血管内凝血死亡外，其余患者
经停药、予糖皮质激素等对症治疗后好转或痊愈。结论 SCARs是OACs罕见且严重的不良反应，多发生在用药后的10～28 d；一
旦怀疑为OACs所致SCARs，临床应及时停药并根据SCARs类型制定治疗方案，以保障患者的用药安全。
关键词 口服抗凝药；严重皮肤不良反应；史-约综合征；中毒性表皮坏死松解症；伴嗜酸性粒细胞增多和系统症状的药物反应；急
性泛发性发疹性脓疱病

Literature analysis of severe cutaneous adverse reactions induced by oral anticoagulants
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ZHENG Shuang ，JIANG Rongrong ，ZHU Jianguo ，XIE Cheng（1. Dept. of Pharmacy， the First Affiliated
Hospital of Soochow University， Jiangsu Suzhou 215006， China；2. Dept. of Pharmacy， Suzhou Hospital of
Integrated Traditional Chinese and Western Medicine， Jiangsu Suzhou 215101， China）
ABSTRACT OBJECTIVE To analyze the characteristics of severe cutaneous adverse reactions （SCARs） induced by oral
anticoagulants （OACs）， and provide a reference for clinical safety of drug use. METHODS Case reports of SCARs caused by
OACs （warfarin， apixaban， rivaroxaban， edoxaban， dabigatran etexilate） were retrieved from PubMed， Embase， CNKI， Wanfang
Data， VIP and other databases with search terms as “oral anticoagulants”“factor Ⅹa inhibitor”“direct thrombin inhibitor” and their
Chinese equivalents. A descriptive statistical analysis was performed. RESULTS A total of 11 articles were included， involving 11
patients in total， among whom there were 5 males （45.5%） and 6 females （54.5%）， with an average age of （59.6±21.5） years.
The primary underlying diseases were mainly atrial fibrillation， pulmonary embolism， joint replacement and valve replacement. The
OACs involved included warfarin in 3 cases， rivaroxaban in 4 cases， apixaban in 2 cases， and dabigatran etexilate in 2 cases.
SCARs occurred from 10 hours to 42 days after treatment， and 7 cases （63.6%） within 10 to 28 days. Among 11 patients， 5 cases
were diagnosed as drug reaction with eosinophilia and systemic symptoms， 4 cases were diagnosed as Stevens-Johnson syndrome or
toxic epidermal necrolysis， and 2 cases were diagnosed as acute generalized exanthematous pustulosis. The clinical manifestations
mainly included rash， fever and mucosal damage， etc. Except for 1 patient who died of sepsis and diffuse intravascular
coagulation， the rest of the patients improved or recovered after withdrawal and treatment with glucocorticoids. CONCLUSIONS
SCARs are rare but serious adverse reactions caused by OACs， typically occurring 10 to 28 days after medication. Once SCARs are
suspected to be caused by OACs， the medication should be discontinued immediately， and a treatment plan should be formulated
based on the type of SCARs to ensure the safety of patients’ drug use.
KEYWORDS oral anticoagulants； severe cutaneous adverse reactions； Stevens-Johnson syndrome； toxic epidermal necrolysis；
drug reaction with eosinophilia and systemic symptoms； acute
generalized exanthematous pustulosis
Δ 基金项目“十二五”国家临床重点专科建设项目（No.国卫办医
函〔2018〕292号）
＊ 第一作者 主 管 药 师 。 研 究 方 向 ：医 院 药 学 。 E-mail：
抗凝是治疗血栓栓塞性疾病的基石。对于需要长
1539822374@qq.com
期进行抗凝治疗的患者，应优选口服抗凝药物（oral anti‐
# 通信作者 副主任药师，硕士。研究方向：临床药学。E-mail：
[1]
xiecheng_1999@163.com coagulants，OACs） 。目前，我国上市的OACs主要包括

· 1500 · China Pharmacy 2025 Vol. 36 No. 12 中国药房 2025年第36卷第12期