目的 分析福州市长乐区医院抗凝药物致严重药品不良反应的发生特点与规律，为临床药物警戒及促进合理用药提供参考。方法 采用回顾性分析的方法，收集福州市长乐区医院2010-2019年上报的135例抗凝药物引发的严重药品不良反应，分别从性别、年龄、用药情况、给药途径和不良反应发生时间分布、累及系统-器官损害及转归等方面进行统计分析。结果 135例患者中男性83例（61.48%）、女性52例（38.52%），男女比例为1.60：1；60~89岁年龄段严重药品不良反应发生率最高；严重药品不良反应主要发生在用药后5 d~6 m；主要累及系统-器官损害为血小板，出血和凝血障碍和肝损伤；经暂停给药、剂量下调和对症处理，治愈24例（17.78%），好转91例（67.41%），不详17例（12.59%），未好转3例（2.22%）。结论 临床医生应重视抗凝药物严重药品不良反应的发生特点，在应用抗凝药物时，严密监测患者的临床症状及凝血功能、肝功能等相关指标，以尽量降低严重药品不良反应对患者造成的损害。

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