| 摘要: |
| 国内外大量惨痛的药源性事件提醒人们需关注药品的安全性。药品监管部门和上市许可持有人要尽可能早地开始收集药品不良反应信息，针对不同的药品制订不同的风险管理计划，以最大程度地保障患者的用药安全。在药品全生命周期管理上，药品不良反应信号检测是上市后安全性监测的重要环节。本文介绍了上市后药品不良反应信号检测常用的不相称测定分析技术的基本原理和数据分析中可能存在的各种偏倚及控制方法，并讨论了用于信号检测的机器学习方法、信号检测报告的规范性等，为提高信号检测的准确性与及时性提供参考。 |
| 关键词: 药品不良反应 药物警戒 信号检测 不相称测定分析 |
| DOI：10.16781/j.CN31-2187/R.20211309 |
| 投稿时间：2021-12-27修订日期：2022-01-17 |
| 基金项目:国家自然科学基金（82073671），上海市公共卫生体系建设三年行动计划学科带头人计划（GWV-10.2-XD22），上海市公共卫生体系建设三年行动计划学科建设项目（GWV-10.1-XK05），军队双重建设项目-03. |
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| Progress and thinking of signal detection methodology on post-marketing adverse drug reaction surveillance |
| YE Xiao-fei* |
(Department of Military Health Statistics, Faculty of Health Services, Naval Medical University(Second Military Medical University), Shanghai 200433, China
*Corresponding author) |
| Abstract: |
| A large number of tragic drug-induced events worldwide have warned the necessity to pay attention to the safety of drugs. Drug regulatory authorities and marketing license holders are obliged to collect information on adverse drug reactions as early as possible and develop different risk management plans for different drugs to maximize the safety of drug users. In the whole life cycle management of drugs, signal detection is an important part of post-marketing safety monitoring. This paper introduces the basic principle of disproportionality analysis used in post-marketing adverse drug reaction surveillance and potential biases and bias control methods in data analysis, and discusses machine learning method for signal detection and the standardization of signal detection report, so as to improve the accuracy and timeliness of signal detection. |
| Key words: adverse drug reaction pharmacovigilance signal detection disproportionality analysis |
