Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database
Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database
复制标题
DOI：
10.5582/bst.2020.03082
复制
发表时间：
2020-04-01
影响因子：
5.5
通讯作者：
Toda, Tatsushi
中科院分区：
文献类型：
--
作者：
Sato, Kenichiro;Mano, Tatsuo;Toda, Tatsushi
2020年3月底至4月初，抗疟疾药物氯喹已在美国和欧洲被批准作为2019年冠状病毒病(新冠肺炎)的紧急治疗药物。尽管不常见，但已有报道称，接受氯喹治疗疟疾或自身免疫性疾病的患者出现了神经精神症状。在这项研究中，为了使用一个大型的自我报告数据库来调查这些不良事件(AEs)，我们对2012年第四季度至2019年第四季度向FDA不良事件报告系统(FAERS)数据库报告的与氯喹(或羟基氯喹)使用相关的神经精神病学AE信号的检测进行了不成比例分析。我们纳入了2,389,474例AE病例，其中520例因使用氯喹而发展为神经精神性AE。使用多水平模型计算了使用氯喹后发生的每一种神经精神不良反应的调整报告优势比(ROR)：暴露于氯喹与遗忘症、精神错乱、幻觉、抑郁和意识丧失的报告有统计学意义的高相关(调整后的ROR和GT；1的较低95%可信区间)，尽管他们的ROR增加的程度有限。没有统计上有意义的任何其他神经精神障碍的高报告，包括自杀、精神病、精神错乱和激越。目前的药物警戒性研究结果没有表明氯喹的使用与自杀、精神病、精神错乱和激越的风险增加之间有任何潜在的联系，这将在紧急使用氯喹治疗新冠肺炎期间提供信息。
In late March and early April 2020, the antimalarial drug, chloroquine, has been approved as an emergency treatment for the coronavirus disease 2019 (COVID- 19) in the United States and in Europe. Although infrequent, neuropsychiatric symptoms have been reported in patients who received chloroquine for the treatment of malaria or autoimmune diseases. In this study, aiming to investigate these adverse events (AEs) using a large self-reporting database, we conducted a disproportionality analysis for the detection of neuropsychiatric AE signals associated with the use of chloroquine (or hydroxychloroquine), reported to FDA Adverse Event Reporting System (FAERS) database between the fourth quarter of 2012 and the fourth quarter of 2019. We included 2,389,474 AE cases, among which 520 cases developed neuropsychiatric AE following the use of chloroquine. Adjusted reporting odds ratio (ROR) for the development of each of the neuropsychiatric AEs following the use of chloroquine was calculated using a multilevel model: exposure to chloroquine was associated with a statistically significant high reporting of amnesia, delirium, hallucinations, depression, and loss of consciousness, (lower 95% confidence interval of the adjusted ROR > 1), although the degree of increase in their ROR was limited. There was no statistically significant high reporting of any other neuropsychiatric AE, including suicide, psychosis, confusion, and agitation. Current pharmacovigilance study results did not suggest any potential link between the use of chloroquine and an increased risk of suicide, psychosis, confusion, and agitation, which would be informative during the emergency use of chloroquine for the treatment of COVID-19.