Lishui Second People's Hospital, Lishui, China.
Department of Neurology, The Affiliated Lihuili Hospital of Ningbo University, Ningbo University, Ningbo, China.
BMC Pharmacol Toxicol. 2024 Aug 12;25(1):49. doi: 10.1186/s40360-024-00772-4.
This study aims to comprehensively assess the safety of Asenapine by conducting an comprehensive statistical analysis of adverse event reports in the FAERS database, with a particular focus on potential adverse reactions related to its use in the treatment of psychiatric disorders.
Event reports from the first quarter of 2009 to the third quarter of 2023 were collected and analyzed. Detailed examinations of gender, age, reporter identity, and other aspects were conducted to reveal the fundamental characteristics of Asenapine-related adverse events. Signal mining techniques were employed to systematically evaluate various adverse reactions associated with Asenapine.
The study found that adverse event reports involving Asenapine were more common among female patients, with the age group mainly distributed between 18 and 45 years. Physicians were the primary reporters of adverse events, and psychiatric disorders, neurological disorders, and gastrointestinal disorders were the most common areas affected by adverse reactions. In addition to known adverse reactions, potential risks not mentioned in the drug label were identified, such as anosognosia, attentional drift, and psychogenic compensation disorder.
Asenapine carries the risk of various adverse reactions alongside its therapeutic effects. In clinical practice, physicians should closely monitor the occurrence of neurological disorders, psychiatric disorders, and gastrointestinal system disorders.
本研究旨在通过对 FAERS 数据库中不良事件报告进行全面的统计分析，综合评估阿塞那平的安全性，特别关注其在治疗精神障碍方面使用时可能出现的不良反应。
收集并分析了 2009 年第一季度至 2023 年第三季度的事件报告。通过详细检查性别、年龄、报告人身份等方面，揭示阿塞那平相关不良事件的基本特征。采用信号挖掘技术系统评估与阿塞那平相关的各种不良反应。
研究发现，涉及阿塞那平的不良事件报告在女性患者中更为常见，年龄组主要分布在 18 至 45 岁之间。医生是不良事件的主要报告人，不良事件主要影响的领域是精神障碍、神经障碍和胃肠道障碍。除了已知的不良反应外，还发现了药物标签中未提及的潜在风险，如认知障碍、注意力漂移和心因性补偿障碍。
阿塞那平在具有治疗效果的同时也存在各种不良反应的风险。在临床实践中，医生应密切监测神经障碍、精神障碍和胃肠道系统障碍的发生情况。
