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Spontaneous cutaneous adverse drug reaction reports—An analysis of a 10‐year dataset in Singapore

机译:自发性皮肤不良药物反应报告-对新加坡10年数据集的分析

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摘要

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.
机译:我们分析了新加坡的自发不良事件数据库,以确定所报告的皮肤不良药物反应(CADR)和致病药物的类型。我们选择了10个相关的CADR,确定了可疑药物和高危人群的特征。根据患者的人口统计资料,CADR的类型,可疑药物,结局和潜伏期,对2006年至2015年收到的系统器官类别“皮肤和附属疾病”的ADR报告进行了分析。在分析的104,372份报告中,女性占56.2%,中国患者占72.5%。平均年龄为41.1岁。报告的最高CADR为皮疹(包括非特异性皮疹,滤泡性皮疹,斑丘疹和水疱疹)(67.2%)和血管性水肿(13.9%)。经常与关注的CADR相关的药物包括非甾体类抗炎药和带血管性水肿的抗生素,碘海醇和荨麻疹,抗癫痫药和别嘌呤醇和史蒂文斯-约翰逊综合征(SJS)/中毒性表皮坏死(TEN)。基于年龄,性别和种族的10个感兴趣的CADR进行的亚组分析显示了以下报告趋势:脱发(女性报告更多),药物过敏综合征(男性更多),血管性水肿(年轻患者更多)和光敏性(老年患者更多)。总体而言,每个感兴趣的CADR的种族分布与新加坡人口的种族分布一致,在SJS / TEN,光敏性和皮肤变色方面观察到轻微的偏差。我们分析了新加坡十年来的CADR报告,并确定了报告的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带来更多价值。

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