Li Kunyu Undergraduate, Shi Shuping Undergraduate, Su Chang Undergraduate, Cao Yiyue Undergraduate, Xiong Qinyu Undergraduate, Zhang Ting PhD, Wu Bin MD
{"title":"基于FDA不良事件报告系统数据的药物性血小板减少症的最新综合药物警戒研究。","authors":"Li Kunyu Undergraduate, Shi Shuping Undergraduate, Su Chang Undergraduate, Cao Yiyue Undergraduate, Xiong Qinyu Undergraduate, Zhang Ting PhD, Wu Bin MD","doi":"10.1002/jcph.2389","DOIUrl":null,"url":null,"abstract":"<p>Drug-induced thrombocytopenia (DIT) deserves both clinical and research attention for the serious clinical consequences and high prevalence of the condition. The current study aimed to perform a comprehensive pharmacovigilance analysis of DIT reported in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, with a particular focus on drugs associated with thrombocytopenia events. A disproportionality analysis of DIT was conducted using reports submitted to FARES from January 2004 to December 2022. Both the information component (IC) and reporting odds ratio (ROR) algorithms were applied to identify an association between target drugs and DIT events. A total of 15,940,383 cases were gathered in FAERS, 168,657 of which were related to DIT events. The top 50 drugs ranked by number of cases and ranked by signal strength were documented. The top 5 drugs ranked by number of cases were lenalidomide (10,601 cases), niraparib (3726 cases), ruxolitinib (3624 cases), eltrombopag (3483 cases), and heparin (3478 cases). The top 5 drugs ranked by signal strength were danaparoid (ROR 37.61, 95%CI 30.46-46.45), eptifibatide (ROR 34.75, 95%CI 30.65-39.4), inotersen (ROR 34.00, 95%CI 29.47-39.23), niraparib (ROR 30.53, 95%CI 29.42-31.69), and heparin (ROR 28.84, 95%CI 27.76-29.97). The top 3 involved drug groups were protein kinase inhibitors, antimetabolites, and monoclonal antibodies and antibody-drug conjugates. The current comprehensive pharmacovigilance study identified more drugs associated with thrombocytopenia. 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引用次数: 0
摘要
药物性血小板减少症(Drug-induced Thrombocytopenia, DIT)因其临床后果严重、发病率高而受到临床和研究的重视。目前的研究旨在对FDA不良事件报告系统(FAERS)数据库中报告的DIT进行全面的药物警戒分析,特别关注与血小板减少事件相关的药物。利用2004年1月至2022年12月提交给FARES的报告,对DIT进行了歧化分析。应用信息成分(IC)和报告优势比(ROR)算法来确定目标药物与DIT事件之间的关联。FAERS共收集病例15940383例,其中168657例与DIT事件相关。记录了按病例数和信号强度排名前50位的药物。病例数前5位依次为来那度胺(10601例)、尼拉帕尼(3726例)、鲁索利替尼(3624例)、依曲波巴(3483例)、肝素(3478例)。按信号强度排序前5位的药物分别是达纳帕肽(ROR = 37.61, 95% CI 30.46 ~ 46.45)、依替巴肽(ROR = 34.75, 95% CI 30.65 ~ 39.4)、intertersen (ROR = 34.00, 95% CI 29.47 ~ 39.23)、尼拉帕尼(ROR = 30.53, 95% CI 29.42 ~ 31.69)和肝素(ROR = 28.84, 95% CI 27.76 ~ 29.97)。前3位涉及的药物组为蛋白激酶抑制剂、抗代谢物、单克隆抗体和抗体-药物偶联物。目前的综合药物警戒研究发现了更多与血小板减少症相关的药物。虽然一些药物已经阐明了DIT的机制,但其他药物仍需要进一步研究。这篇文章受版权保护。版权所有。
An Updated Comprehensive Pharmacovigilance Study of Drug-Induced Thrombocytopenia Based on FDA Adverse Event Reporting System Data
Drug-induced thrombocytopenia (DIT) deserves both clinical and research attention for the serious clinical consequences and high prevalence of the condition. The current study aimed to perform a comprehensive pharmacovigilance analysis of DIT reported in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, with a particular focus on drugs associated with thrombocytopenia events. A disproportionality analysis of DIT was conducted using reports submitted to FARES from January 2004 to December 2022. Both the information component (IC) and reporting odds ratio (ROR) algorithms were applied to identify an association between target drugs and DIT events. A total of 15,940,383 cases were gathered in FAERS, 168,657 of which were related to DIT events. The top 50 drugs ranked by number of cases and ranked by signal strength were documented. The top 5 drugs ranked by number of cases were lenalidomide (10,601 cases), niraparib (3726 cases), ruxolitinib (3624 cases), eltrombopag (3483 cases), and heparin (3478 cases). The top 5 drugs ranked by signal strength were danaparoid (ROR 37.61, 95%CI 30.46-46.45), eptifibatide (ROR 34.75, 95%CI 30.65-39.4), inotersen (ROR 34.00, 95%CI 29.47-39.23), niraparib (ROR 30.53, 95%CI 29.42-31.69), and heparin (ROR 28.84, 95%CI 27.76-29.97). The top 3 involved drug groups were protein kinase inhibitors, antimetabolites, and monoclonal antibodies and antibody-drug conjugates. The current comprehensive pharmacovigilance study identified more drugs associated with thrombocytopenia. Although the mechanisms of DIT have been elucidated for some drugs, others still require further investigation.