目的 分析南京地區(qū)嚴(yán)重藥品不良反應(yīng)/事件的發(fā)生規(guī)律和特點(diǎn)，為推進(jìn)藥品不良反應(yīng)監(jiān)測(cè)工作和臨床合理用藥提供參考。方法 從國(guó)家藥品不良反應(yīng)監(jiān)測(cè)系統(tǒng)庫南京市藥品不良反應(yīng)監(jiān)測(cè)中心調(diào)取并篩選2017年接收的嚴(yán)重藥品不良反應(yīng)/事件數(shù)據(jù)，將患者性別、年齡、懷疑藥品名稱、嚴(yán)重不良反應(yīng)/事件名稱、過程描述等信息進(jìn)行統(tǒng)計(jì)分析。結(jié)果 358份嚴(yán)重藥品不良反應(yīng)/事件報(bào)告中，新的嚴(yán)重的不良反應(yīng)占23.18%。60歲以上患者占48.60%?？垢腥舅幬锖涂鼓[瘤藥物發(fā)生率較高，分別為115例（32.12%）和80例（22.35%）。靜脈滴注為主要的給藥方式（294例，82.12%）。在累及器官、系統(tǒng)中，全身性損害發(fā)生頻次最高（195頻次，28.97%），其次為呼吸系統(tǒng)損害。結(jié)論 本次分析中嚴(yán)重藥品不良反應(yīng)/事件與患者年齡、給藥途徑、藥品種類有關(guān)。醫(yī)療機(jī)構(gòu)、經(jīng)營(yíng)企業(yè)和生產(chǎn)企業(yè)應(yīng)加強(qiáng)嚴(yán)重藥品不良反應(yīng)/事件的監(jiān)測(cè)，促進(jìn)合理用藥。

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.

南京藥學(xué)會(huì)——常州四藥醫(yī)院藥學(xué)科研基金資助（2018YX001）