目的 对国际上大数据技术在药物警戒中的应用和发展情况进行回顾总结，为完善我国药物警 戒系统提供参考。方法 对官方文件以及近几年来国内外相关文献中报道的大数据在药物警戒中的 应用进行整理、分析与归纳，并以药物性肝损伤为案例进行分析。结果 越来越多的国家逐步开始建 立药物警戒的数据库、协作网络及联盟，其中大数据技术发挥了很大的作用，不仅用于药品不良事件 的监测和分析，还可以形成辅助药物警戒的预测模型，对不良反应进行预警和防范。结论 药物警戒 的发展模式已经发生改变，未来大数据技术在药物警戒中的作用会更加显著，我国可以借鉴国际发 展经验，积极探索适合我国的药物警戒发展道路。 Objective To review and summarize the recent developments and applications of big data technology in pharmacovigilance in order to shed light on possible measures for improving the identification of adverse drug events in China. Methods Official documents from developed countries and recent literature were searched to identify, analyze and summarize the status quo and future developments of big data applications in pharmacovigilance. To elucidate the findings, drug-induced liver injury was used as a case study. Results An increasing number of countries are establishing registries and databases, collaboration networks and alliances to support the big data approach to pharmacovigilance. Big data has played a big role not only in the monitoring and analysis of adverse drug events, but also in the establishment of predictive models of adjuvant pharmacovigilance to predict and prevent potential adverse reactions. Conclusion The development paradigm of pharmacovigilance has changed, and the role of big data in pharmacovigilance will become more prominent in the future. For China, we can learn from other countries to make more informed decisions on the strategies for advancing the pharmacovigilance system. Keywords: pharmacovigilance; big data; real world data; drug-induced liver injury.