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阿伐普替尼引起的光敏反应:药物警戒分析

Photosensitivity From Avapritinib: Pharamacovigilance Analysis.

作者信息

Venkatakrishnan Ajit, Chu Brandon, Aggarwal Pushkar

机构信息

University of Cincinnati, Cincinnati, OH, United States.

University of Maryland, College Park, MD, United States.

出版信息

JMIR Dermatol. 2022 Aug 10;5(3):e39229. doi: 10.2196/39229.

Abstract

Certain protein kinase inhibitors have been reported to cause photosensitivity. Avapritinib is a tyrosine kinase inhibitor that was approved in January 2020. The aim of this analysis was to determine if a statistically significant signal exists between Avapritinib and photosensitivity in the real-world population. A disproportionality analysis was conducted using the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 1, 2020, to December 31, 2021. A literature review was also performed to identify case reports of Avapritinib-induced photosensitivity. A total of 13 adverse event reports with Avapritinib as the drug and photosensitivity as the reaction were identified in FAERS. Avapritinib was the suspect drug in all 13 reports, and in 12 of the 13 reports, Avapritinib was the only drug listed. Disproportionality analysis found a proportional reporting ratio of 11.0, χ=107, reporting odds ratio of 11.0, and a lower limit of the 95% CI of the information component of 2.1. The literature review found 1 case report of Avapritinib-induced photosensitivity in a patient who had been taking Avapritinib 300 mg daily for 5 months. A statistically significant signal was found between Avapritinib use and photosensitivity. Clinicians should continue to balance the benefits and risks when prescribing Avapritinib to patients.

摘要

据报道,某些蛋白激酶抑制剂会引起光敏反应。阿伐替尼是一种酪氨酸激酶抑制剂,于2020年1月获得批准。本分析的目的是确定在真实世界人群中,阿伐替尼与光敏反应之间是否存在具有统计学意义的信号。使用美国食品药品监督管理局不良事件报告系统(FAERS)对2020年1月1日至2021年12月31日的数据进行了不成比例分析。还进行了文献综述,以确定阿伐替尼引起光敏反应的病例报告。在FAERS中,共识别出13份以阿伐替尼为药物、光敏反应为不良反应的报告。在所有13份报告中,阿伐替尼均为可疑药物,且在13份报告中的12份中,阿伐替尼是唯一列出的药物。不成比例分析发现比例报告比值为11.0,χ=107,报告比值比为11.0,信息成分95%CI的下限为2.1。文献综述发现1例阿伐替尼引起光敏反应的病例报告,该患者每天服用300mg阿伐替尼,持续5个月。在使用阿伐替尼与光敏反应之间发现了具有统计学意义的信号。临床医生在给患者开阿伐替尼处方时应继续权衡利弊。

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