目的 通过分析2004—2020年河南省药品不良反应监测平台收到的复方丹参片不良反应/事件报告，探讨复方丹参片ADR/ADE发生的规律和特点，为其临床安全用药提供参考。方法 采用回顾性分析方法，ADR/ADE共纳入1 561例病例，对患者的人口学信息、发生ADR/ADE时间、累及系统、ADR/ADE表现及转归进行综合分析。结果 复方丹参片ADR/ADE多发于中老年人群，用药1 d内发生率较高，转归情况良好，常见累及系统损害为胃肠系统、皮肤及其附件系统和中枢及外周神经系统，使用中可引起低钾血症及出血。结论 医疗机构在使用该药过程中，要严格遵循说明书规范用药，医嘱患者使用时应注意其不良反应情况，以确保及早发现，及时处理。

Objective To analyze the ADR/ADE reports of Compound Danshen Tablets collected by Henan ADR monitoring platform from 2004 to 2020, and to explore the regularity and characteristics of the ADR/ADE of Compound Danshen Tablets. Methods 1 561 Cases were analyzed retrospectively, including the demographic information, the time of occurrence of ADR/ADE, the involved system, the performance and outcome of ADR/ADE.Results ADR/ADE of Compound Danshen Tablets is more common in middle-aged and elderly people, with a high incidence within 1 day of administration and good outcome. The commonly involved systemic damage is damage to gastrointestinal system, skin and its accessory system, central and peripheral nervous system, and can cause hypokalemia and bleeding during use. Conclusion In the process of using this drug, medical institutions should strictly follow the specification of drug use, and patients should pay attention to the adverse reactions when using it, so as to ensure early detection and timely treatment.

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