利伐沙班致皮疹文献病例分析

Literature Analysis of Rash Caused by Rivaroxaban

目的:探究利伐沙班导致皮疹的特点,为患者安全用药提供参考。方法:检索国内外数据库,获得利伐沙班致皮疹的病例报道文献,对病例的患者年龄、性别、既往病史,利伐沙班使用目的、使用剂量、联合用药,药品不良反应(ADR)出现时间、临床表现、处理、预后等信息,以及ADR关联性评价结果进行统计分析。结果:共检索获得16篇文献(16例患者)。ADR患者男女比例为1∶1,>60岁老年患者11例(68. 7%)。16例患者中14例的利伐沙班给药剂量符合药品说明书规定,12例患者联用了其他药物;5例(31. 3%)患者用药后第3天出现皮疹,3例(18. 8%)在用药10 d时出现。16例均出现全身多处散在红斑,其中8例明确诊断为伴嗜酸粒细胞增多及系统症状的药疹综合征、特发性血小板减少性紫癜、白细胞破碎性血管炎、血清病和神经性水肿;患者经治疗后症状改善。5例患者关联性评价为"很可能有关",11例为"可能有关"。结论:临床工作中要关注利伐沙班导致的皮疹,长期服药患者仍应引起重视。

Objective:To investigate the characteristics of rash induced by rivaroxaban and provide a reference for safe drug use. Methods:Domestic and foreign literature databases were searched and case reports of rash caused by rivaroxaban were screened. Information such as age, gender, primary disease, the purpose of using rivaroxaban, dosage, combined medication, time of ADR, clinical feature, treatment, outcome, and the results of ADR correlation evaluation were statistically analyzed. Results:16 case reports were selected(16 patients). The ratio of male to female was 1∶1, and there were 11 elderly patients(68.7%) older than 60 years. The dose of rivaroxaban in 14 of the 16 patients complied with the drug instructions, 12 patients had concomitant medication, 5 patients(31.3%) developed a rash after d3, followed by d10(3 cases, accounting for 18.8%). All 16 patients showed multiple erythema scattered throughout the body, 8 of them were diagnosed with drug reaction with eosinophilia and systemic symptoms, idiopathic thrombocytopenic purpura, leukocytoclastic vasculitis, serum disease and angioedema, and symptoms improved after treatment. Relevance was evaluated as "probable" in 5 patients and "possible" in 11 patients. Conclusion:Rash caused by rivaroxaban should be noticed during clinical working, patients who took long-term medication should still pay attention.