目的 分析福州市長樂區(qū)醫(yī)院抗凝藥物致嚴(yán)重藥品不良反應(yīng)的發(fā)生特點(diǎn)與規(guī)律，為臨床藥物警戒及促進(jìn)合理用藥提供參考。方法 采用回顧性分析的方法，收集福州市長樂區(qū)醫(yī)院2010-2019年上報的135例抗凝藥物引發(fā)的嚴(yán)重藥品不良反應(yīng)，分別從性別、年齡、用藥情況、給藥途徑和不良反應(yīng)發(fā)生時間分布、累及系統(tǒng)-器官損害及轉(zhuǎn)歸等方面進(jìn)行統(tǒng)計(jì)分析。結(jié)果 135例患者中男性83例（61.48%）、女性52例（38.52%），男女比例為1.60：1；60~89歲年齡段嚴(yán)重藥品不良反應(yīng)發(fā)生率最高；嚴(yán)重藥品不良反應(yīng)主要發(fā)生在用藥后5 d~6 m；主要累及系統(tǒng)-器官損害為血小板，出血和凝血障礙和肝損傷；經(jīng)暫停給藥、劑量下調(diào)和對癥處理，治愈24例（17.78%），好轉(zhuǎn)91例（67.41%），不詳17例（12.59%），未好轉(zhuǎn)3例（2.22%）。結(jié)論 臨床醫(yī)生應(yīng)重視抗凝藥物嚴(yán)重藥品不良反應(yīng)的發(fā)生特點(diǎn)，在應(yīng)用抗凝藥物時，嚴(yán)密監(jiān)測患者的臨床癥狀及凝血功能、肝功能等相關(guān)指標(biāo)，以盡量降低嚴(yán)重藥品不良反應(yīng)對患者造成的損害。

Objective To analyze the occurrence characteristics and rules of serious adverse drug reactions caused by anticoagulants in Fuzhou Changle District Hospital, so as to provide reference for clinical pharmacovigilance and promoting rational use of drugs. Methods 135 cases of serious adverse drug reactions caused by anticoagulants reported in Fuzhou Changle District Hospital from 2010 to 2019 were analyzed in terms of gender, age, medication situation, administration route, time distribution of adverse drug reactions, system organ damage and outcome. Results Of the 135 patients, 83 were male (61.48%), 52 were female (38.52%), the ratio of male to female is 1.60:1, the incidence of severe adverse drug reactions was highest in the age group from 60 to 89. Severe adverse drug reactions mainly occurred from 5 days to 6 months after treatment. The main system-organ damage was platelet, bleeding and coagulation disorders, and liver injury. After suspension of administration, dose reduction and symptomatic treatment, 24 cases (17.78%) were cured, 91 cases (67.41%) were improved, 17 cases (12.59%) were unknown, and 3 cases (2.22%) were not improved. Conclusion Clinicians should pay attention to the occurrence characteristics of severe adverse drug reactions caused by anticoagulants. During the application of anticoagulants, patients' clinical symptoms, coagulation function, liver function and other related indicators should be closely monitored to minimize the damage caused by serious adverse drug reactions to patients.

R926