Effective monitoring and analysis of adverse drug reactions by drug regulatory authorities
药品监管部门对药品不良反应的有效监测分析

摘要

目的 探讨药品监管部门对药品不良反应的有效监测方法及效果。方法 本次研究对象是91例上报的药品不良反应事件，上报时间为2024年10月-2025年10月，分析不良反应涉及的器官、系统以及药品种类。结果 药品不良反应损害部位方面，38.46%为皮肤、31.87%为心血管系统、9.89%为免疫系统、8.79%为神经系统。引起不良反应的药品种类方面，46.15%为抗生素、16.48%为中成药、9.89%微量元素/离子、8.79%为祛痰药。结论 药品监管部门需要根据药品不良反应监测中的缺陷制定针对性管理措施，提高监测的有效性，以减少药品不良反应，提高公众用药安全性。

Abstract

Objective To explore the effective monitoring methods and effects of adverse drug reactions by drug regulatory authorities.
Methods The research subjects of this study were 91 reported adverse drug reaction events, which were reported from October 2024 to October 2025. The organs, systems and types of drugs involved in the adverse reactions were analyzed.
Results Regarding the sites of damage caused by adverse drug reactions, 38.46% were in the skin, 31.87% in the cardiovascular system, 9.89% in the immune system, and 8.79% in the nervous system. In terms of the types of drugs causing adverse reactions, 46.15% were antibiotics, 16.48% were traditional Chinese patent medicines, 9.89% were trace elements/ions, and 8.79% were expectorants.
Conclusion   Drug regulatory authorities need to formulate targeted management measures based on the deficiencies in adverse drug reaction monitoring to enhance the effectiveness of monitoring, thereby reducing adverse drug reactions and improving the safety of public medication.