维洛沙嗪与右旋苯丙胺不良反应谱的真实世界药物警戒比较。

Real world pharmacovigilance comparison of viloxazine and dextroamphetamine adverse reaction profiles.

作者信息

Wang Lijun, Kong Qingyang, Li Yixuan

机构信息

Department of Pharmacy, Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine (Taicang Hospital of Traditional Chinese Medicine), Taicang, China.

School of Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing, China.

出版信息

Sci Rep. 2025 Aug 7;15(1):28919. doi: 10.1038/s41598-025-14385-2.

Abstract

Viloxazine and dextroamphetamine as newly approved drugs for the medical treatment of Attention Deficit Hyperactivity Disorder (ADHD) in recent years give new options for the treating of related disorders, including anxiety, and depression. In our research, we conducted an assessment of adverse drug reactions (ADRs) associated with the utilization of these two medications, as documented in the database. By analyzing the adverse drug reaction profiles and combining them with relevant reviews, we aim to help select the drug with the least risk to meet the specific needs of different patients. A retrospective descriptive analysis method was used in this study. The study classified two ADHD medications and extracted adverse drug reaction (ADR) reports for these medications from the World Health Organization-VigiAccess database. Data collected included patient demographic characteristics such as gender and age group, as well as geographic distribution based on global ADR reports. We compared the similarities and differences between the ADRs of the two drugs by calculating the proportion of ADRs reported for each drug. Finally, we also compared the most common general disorders and administration site conditions for various adverse effects. VigiAccess reported a total of 5394 adverse events (AEs) related to these two drugs. The most commonly reported age group was between 18 and 44 years and the three most common types of AEs were: general disease and site of administration conditions (2,548 cases, 20.5%), psychiatric disorders (2,012 cases, 16.1%) and neurologic disorders (1,822 cases, 14.6%). Dextroamphetamine had a significantly higher rate of reported adverse reactions in general disorders and administration site conditions compared to viloxazine. Beyond that there are other differences that exist. Using real-world data from WHO-VigiAccess and FAERS, we identified existing potential adverse reactions associated with viloxazine and dextroamphetamine, providing valuable insights for clinical reference. Although the study benefits from database utilization, its limitation lies in the spontaneous reporting system. Accurate drug safety evaluation requires future enhancements.

摘要

维洛沙嗪和右旋苯丙胺作为近年来新批准用于治疗注意力缺陷多动障碍(ADHD)的药物,为治疗包括焦虑和抑郁在内的相关疾病提供了新的选择。在我们的研究中,我们对数据库中记录的与使用这两种药物相关的药物不良反应(ADR)进行了评估。通过分析药物不良反应概况并将其与相关综述相结合,我们旨在帮助选择风险最小的药物,以满足不同患者的特定需求。本研究采用回顾性描述性分析方法。该研究对两种治疗ADHD的药物进行分类,并从世界卫生组织药物警戒数据库中提取这些药物的药物不良反应(ADR)报告。收集的数据包括患者人口统计学特征,如性别和年龄组,以及基于全球ADR报告的地理分布。我们通过计算每种药物报告的ADR比例来比较两种药物ADR之间的异同。最后,我们还比较了各种不良反应最常见的一般疾病和给药部位情况。药物警戒数据库报告了与这两种药物相关的总共5394例不良事件(AE)。报告的最常见年龄组为18至44岁,最常见的三种AE类型为:一般疾病和给药部位情况(2548例,20.5%)、精神障碍(2012例,16.1%)和神经障碍(1822例,14.6%)。与维洛沙嗪相比,右旋苯丙胺在一般疾病和给药部位情况方面报告的不良反应发生率明显更高。除此之外还存在其他差异。利用世界卫生组织药物警戒数据库和美国食品药品监督管理局不良事件报告系统(FAERS)的真实世界数据,我们确定了与维洛沙嗪和右旋苯丙胺相关的现有潜在不良反应,为临床参考提供了有价值的见解。尽管该研究受益于数据库的使用,但其局限性在于自发报告系统。准确的药物安全性评估需要未来进一步改进。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/babb/12332145/b998e5116089/41598_2025_14385_Fig1_HTML.jpg

相似文献

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索