Department of Pharmacy Faculty of Science National University of Singapore Singapore Singapore.
Vigilance and Compliance Branch Health Sciences Authority Singapore Singapore.
Pharmacol Res Perspect. 2019 Mar 13;7(2):e00469. doi: 10.1002/prp2.469. eCollection 2019 Apr.
We analyzed the spontaneous adverse event database in Singapore to determine the types of cutaneous adverse drug reactions (CADRs) and causative drugs reported. We selected 10 CADRs-of-interest, and identified the suspected drugs and the characteristics of the at-risk population. ADR reports received from 2006 to 2015 of the system organ class "Skin and Appendages Disorders" were analyzed based on patient demographics, the types of CADRs, suspected drugs, outcome, and latency period. Of the 104 372 reports analyzed, 56.2% involved females and 72.5% involved Chinese patients. The mean age was 41.1 years old. The top CADRs reported were rash (including nonspecified rash, follicular rash, maculopapular rash, and vesicular rash) (67.2%) and angioedema (13.9%). The drugs frequently associated with the CADRs-of-interest include nonsteroidal antiinflammatory drugs and antibiotics with angioedema, iohexol with urticaria, and antiepileptics and allopurinol with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). A subgroup analysis based on age, sex, and race on the 10 CADRs-of-interest showed the following trends in reporting: Alopecia (reported more in females), drug hypersensitivity syndrome (more in males), angioedema (more in younger patients), and photosensitivity (more in older patients). In general, the racial distribution across each CADR-of-interest was consistent with that of Singapore's population, with slight deviations observed for SJS/TEN, photosensitivity and skin discoloration. We analyzed CADR reports from Singapore over 10 years, and identified the types of CADRs reported, and their associated drugs, latency periods and patient characteristics. Such information could add value to healthcare professionals as they assess CADR cases and evaluate suspected drugs.
我们分析了新加坡的自发不良事件数据库,以确定报告的皮肤不良反应(CADR)类型和引起这些反应的药物。我们选择了 10 种感兴趣的 CADR,确定了可疑药物和易患人群的特征。根据患者人口统计学、CADR 类型、可疑药物、结果和潜伏期,分析了 2006 年至 2015 年系统器官分类“皮肤和附属器疾病”收到的药物不良反应报告。在分析的 104372 份报告中,56.2%涉及女性,72.5%涉及中国患者。平均年龄为 41.1 岁。报告的主要 CADR 是皮疹(包括未特指皮疹、滤泡疹、斑丘疹和水疱疹)(67.2%)和血管性水肿(13.9%)。与感兴趣的 CADR 相关的常见药物包括具有血管性水肿的非甾体抗炎药和抗生素、与荨麻疹相关的碘海醇、与史蒂文斯-约翰逊综合征(SJS)/中毒性表皮坏死松解症(TEN)相关的抗癫痫药和别嘌醇。对 10 种感兴趣的 CADR 进行基于年龄、性别和种族的亚组分析,报告趋势如下:脱发(女性报告更多)、药物超敏反应综合征(男性更多)、血管性水肿(年轻患者更多)和光敏感性(老年患者更多)。一般来说,每种 CADR 的种族分布与新加坡人口的分布一致,但 SJS/TEN、光敏感性和皮肤变色的分布略有偏差。我们分析了新加坡 10 多年的 CADR 报告,确定了报告的 CADR 类型及其相关药物、潜伏期和患者特征。这些信息可以为医疗保健专业人员评估 CADR 病例和评估可疑药物提供参考。