Emerging Causes of Drug-Induced Anaphylaxis: A Review of Anaphylaxis-Associated Reports in the FDA Adverse Event Reporting System (FAERS).
Emerging Causes of Drug-Induced Anaphylaxis: A Review of Anaphylaxis-Associated Reports in the FDA Adverse Event Reporting System (FAERS).
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药物性过敏反应的新原因：FDA不良事件报告系统（FAERS）中过敏反应相关报告的综述。
DOI：
10.1016/j.jaip.2020.09.021
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Stone CA Jr
中科院分区：
文献类型：
--
作者：
Yu RJ;Krantz MS;Phillips EJ;Stone CA Jr
药物引起的过敏反应是某些药物类药物的一种众所周知的不良反应，但新出现的药物过敏反应的原因和新的机制可能以未知的方式起作用。我们试图确定FDA不良事件报告系统(FAERS)中报告的与过敏反应和紧随其后的死亡相关的顶级药物。我们审查了1999-2019年可公开获得的FAERS数据库。使用“过敏性休克”或“过敏性反应”并按通用药物名称分类病例，我们统计并趋势分析FAERS的报告，其中一种药物与过敏反应或过敏反应相关，然后死亡。从1999-2019年，FAERS共报告了17,506,002起药物不良事件，其中47,496起(0.27%)报告为过敏反应。剔除没有年龄、性别或国家数据的患者，过敏反应报告中患者的中位年龄为52岁[IQR：28]，62.71%是女性，13899/34381(40.43%)来自美国。共有2,984/47,496例(6.28%)发生过敏反应并死亡。FAERS中与过敏反应相关的药物类别最多的是抗生素、单抗、非甾体抗炎药和对乙酰氨基酚。与过敏性死亡相关的主要药物类别是抗生素、放射造影剂和术中药物。线性回归分析显示，mAbs过敏反应报告平均每年占总过敏反应报告的0.77%(95%CI：0.65，0.88)，从1999年的2.00%上升到2019年的17.37%，比任何其他药物类别都快。抗生素总体上过敏反应的报道很多，过敏反应紧随其后的是死亡。越来越多的报告指出，对单抗治疗的过敏反应。
Drug induced anaphylaxis is a well-known adverse drug reaction for some drug classes, but emerging drug causes of anaphylaxis and novel mechanisms may contribute in unrecognized ways. We sought to determine the top drugs reported in association with anaphylaxis and anaphylaxis followed by death in the FDA Adverse Event Reporting System (FAERS). We reviewed the publicly available FAERS database from 1999-2019. Using search terms “anaphylactic shock” or “anaphylactic reaction” and sorting cases by generic drug names, we counted and trended reports to FAERS in which a drug was associated with anaphylaxis or anaphylaxis followed by death. From 1999-2019, there were 17,506,002 adverse drug events reported in FAERS, of which 47,496 (0.27%) were reported as anaphylaxis. Excluding patients without age, sex, or country data, respectively, the median age of patients in reports of anaphylaxis was 52 [IQR: 28], 62.71% were female, and 13,899/34,381 (40.43%) reports were from the US. There were 2,984/47,496 (6.28%) reports of anaphylaxis followed by death. Top drug classes associated with anaphylaxis in FAERS were antibiotics, monoclonal antibodies (mAbs), NSAIDs and acetaminophen. Top drug classes associated with anaphylaxis deaths were antibiotics, radiocontrast agents and intraoperative agents. Linear regression demonstrated reports of anaphylaxis to mAbs increasing at an average rate of 0.77 percent of total anaphylaxis reports per year (95% CI: 0.65, 0.88)from 2.00% in 1999 to 17.37% in 2019, faster than any other drug class. Antibiotics were highly reported for anaphylaxis overall and anaphylaxis followed by death. Increasing reports were noted for anaphylaxis to monoclonal antibody therapies.
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DOI：
10.1186/1756-9966-30-93
发表时间：
2011-10-05
期刊：
Journal of experimental & clinical cancer research : CR
影响因子：
--
作者：
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DOI：
10.1016/j.jaci.2016.04.051
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