基于美国FAERS数据库的维泊妥珠单抗不良事件信号挖掘

doi:10.19803/j.1672-8629.20240215

摘要/Abstract

摘要： 目的从美国食品药品监督管理局（FDA）不良事件报告系统( adverse event reporting system, FAERS）数据库中挖掘信息,分析维泊妥珠单抗不良反应信号,为临床安全用药提供参考。方法利用SAS 9.4对美国FAERS数据库中2004年1月1日至2023年6月30日的报告进行筛选,并采用报告比值比(ROR)和信息成分法(IC)对筛选出的数据进行信号值的计算,再根据信号检测标准进行判断。结果筛选出首要怀疑药物(PS)为维泊妥珠单抗的报告636份,除去产品问题、各种手术及医疗操作和原发疾病相关药品不良事件（ADE）等信号后,维泊妥珠单抗相关ADE信号阳性的报告例次共233例次。其中,维泊妥珠单抗相关ADE报告例次排名靠前的有超说明书使用、新型冠状病毒肺炎(COVID-19)、发热、血小板计数降低和血细胞减少症等,其中COVID-19、肾功能损害和心力衰竭等首选语未被药品说明书收录;信号强度排名靠前的有锁骨下静脉狭窄、巨细胞病毒胃肠溃疡、嗅觉障碍等,其中,锁骨下静脉狭窄、嗅觉障碍等首选语未被药品说明书收录。结论维泊妥珠单抗可疑信号的挖掘大致与说明书一致。在维泊妥珠单抗的使用过程中,除密切关注中性粒细胞减少、血小板减少、周围神经病变等说明书提及的不良反应外,还需警惕肾功能衰竭、心力衰竭、血栓栓塞症以及COVID-19感染等潜在ADE,可以密切监测血常规、心肾功能,并观察是否有感觉、运动和自主神经功能异常的情况出现,必要时及时采取防治措施,降低临床用药风险。

关键词: 维泊妥珠单抗, 药品不良事件, 安全性, 信号挖掘, 美国食品药品监督管理局不良事件报告系统

Abstract: Objective To mine information from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze adverse reaction signals of polatuzumab vedotin for clinical use. Methods The reports in the FAERS database collected between January 1, 2004 and June 30, 2023 were screened using SAS 9.4, and the signal values of the screened data were calculated by using the reporting odds ratio (ROR) and information component (IC) before being assessed according to the signal detection criteria. Results The number of reports that screened polatuzumab vedotin as the primary suspect drug (PS) was 636. After such signals were excluded as product defects, surgical and medical procedures and primary disease, 233 cases of positive polatuzumab vedotin-related AD signals were recorded. The ADE signals that ranked high in terms of the number of reported cases included off-label use, COVID-19, pyrexia, platelet count decreases and cytopenia. Among them, such signals as COVID-19, renal impairment and cardiac failure were not included in the labels. ADE signals with higher strength included subclavian vein stenosis, cytomegalovirus gastrointestinal ulcer and olfactory dysfunction, but subclavian vein stenosis and olfactory dysfunction were not included in the labels. Conclusion The suspicious signals for polatuzumab vedotin mined so far are generally consistent with those specified in the instructions. The use of polatuzumab vedotin requires not only close attention to such adverse reactions mentioned in the label as neutropenia, thrombocytopenia and peripheral neuropathy, but vigilance to potential ADE, such as renal failure, cardiac failure, thromboembolism, and COVID-19 infection. Blood test, cardiac and renal function should be closely monitored. Abnormalities of sensory nerves, motor nerves and autonomic nerves have to be observed. Immediate preventive and curative measures are needed to reduce the risk of clinical medications when necessary.

Key words: polatuzumab vedotin, adverse drug events, safety, data mining, FAERS

中图分类号:

顾晨晨, 宗留留, 姚亚敏, 沈杰. 基于美国FAERS数据库的维泊妥珠单抗不良事件信号挖掘[J]. 中国药物警戒, 2024, 21(10): 1159-1165.

GU Chenchen, ZONG Liuliu, YAO Yamin, SHEN Jie. Mining of adverse event signals of polatuzumab vedotin based on FAERS[J]. Chinese Journal of Pharmacovigilance, 2024, 21(10): 1159-1165.

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