目的 分析南京地区严重药品不良反应/事件的发生规律和特点，为推进药品不良反应监测工作和临床合理用药提供参考。方法 从国家药品不良反应监测系统库南京市药品不良反应监测中心调取并筛选2017年接收的严重药品不良反应/事件数据，将患者性别、年龄、怀疑药品名称、严重不良反应/事件名称、过程描述等信息进行统计分析。结果 358份严重药品不良反应/事件报告中，新的严重的不良反应占23.18%。60岁以上患者占48.60%。抗感染药物和抗肿瘤药物发生率较高，分别为115例（32.12%）和80例（22.35%）。静脉滴注为主要的给药方式（294例，82.12%）。在累及器官、系统中，全身性损害发生频次最高（195频次，28.97%），其次为呼吸系统损害。结论 本次分析中严重药品不良反应/事件与患者年龄、给药途径、药品种类有关。医疗机构、经营企业和生产企业应加强严重药品不良反应/事件的监测，促进合理用药。

Objective To analyze the occurrence characteristics and regularity of serious adverse drug reactions/events and provide reference for the detection of adverse drug reaction signals and clinical rational drug use. Methods The serious adverse drug reactions/events reports were screened from the National Adverse Drug Reaction Monitoring System Database, which were received by Nanjing adverse drug reaction monitoring center in 2017. The gender, age, suspected drug, serious adverse reactions/event, process description and other information were analyzed statistically.Results New serious adverse reactions accounted for 23.18%. Patients who were over 60 years old accounted for 48.60% in the 358 serious adverse drug reactions/events reports. The incidence of serious adverse drug reactions/events was higher in anti-infectives and oncology drugs, which were 115 (32.12%) and 80 (22.35%) cases, respectively. Intravenous administration was the most important mode of administration, which were 294 cases, accounting for 82.12%. Systemic damage occurred the most frequently, which were 195 cases and accounted for 28.97%, followed by respiratory damage.Conclusion In this study, serious adverse drug reactions/events are related to the patient's age, administration route, and type of drug. Medical institutions, operating and production enterprises should reinforce the monitoring of serious adverse drug reactions/incidents and promote rational drug use.

南京药学会——常州四药医院药学科研基金资助（2018YX001）