目的 通過分析2004—2020年河南省藥品不良反應監(jiān)測平臺收到的復方丹參片不良反應/事件報告，探討復方丹參片ADR/ADE發(fā)生的規(guī)律和特點，為其臨床安全用藥提供參考。方法 采用回顧性分析方法，ADR/ADE共納入1 561例病例，對患者的人口學信息、發(fā)生ADR/ADE時間、累及系統(tǒng)、ADR/ADE表現(xiàn)及轉歸進行綜合分析。結果 復方丹參片ADR/ADE多發(fā)于中老年人群，用藥1 d內發(fā)生率較高，轉歸情況良好，常見累及系統(tǒng)損害為胃腸系統(tǒng)、皮膚及其附件系統(tǒng)和中樞及外周神經(jīng)系統(tǒng)，使用中可引起低鉀血癥及出血。結論 醫(yī)療機構在使用該藥過程中，要嚴格遵循說明書規(guī)范用藥，醫(yī)囑患者使用時應注意其不良反應情況，以確保及早發(fā)現(xiàn)，及時處理。

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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