【摘要】 目的 利用FAERS数据库检索替加环素不良事件报告情况，并进行数据挖掘和分析，为临床安全用药提供参考。方法 检索FAERS数据库2005年1月1日至2021年9月30日期间替加环素不良事件报告数据并对相关数据进行分析。结果 共检索到替加环素相关不良事件报告2239份。经报告比值比（ROR）法和英国药品和健康产品管理局（MHRA）综合法检测，替加环素不良事件信号涉及血液及淋巴系统、胃肠系统和肝胆系统等，其中信号较强的为胆石性肠梗阻（PRR=2882.77）、低纤维蛋白原血症（PRR=1267.48）及非血小板减少性紫癜（PRR=1067.69）等。其中胆石性肠梗阻（PRR=2882.77）及非血小板减少性紫癜（PRR=1067.69）等在说明书中未出现但报告数较多且信号较强。结论 临床医务人员在使用替加环素时，除关注低纤维蛋白原血症等药品说明书中已有的不良事件外，还应密切关注胆石性肠梗阻等说明书中未收录但信号值较强的不良事件，保证患者用药的安全性和有效性。更多还原

【Abstract】 Objective To retrieve the adverse event reports of tigecycline using the FAERS database, and conduct data mining and analysis to provide reference for safe drug use. Methods The adverse event reports of tigecycline from January 1, 2005 to September 30, 2021 were retrieved and analyzed. Results A total of 2239 adverse event reports related to tigecycline were retrieved. Using the reporting odds ratio(ROR) method and the combined method of the UK Medicines and Health Products Regulatory Agency(MHRA), signals of adverse events involving multiple systems such as blood and lymphatic system, gastrointestinal system, and hepatobiliary system were identified. The events with the higher signals were gallstone intestinal obstruction(PRR=2882. 77), hypofibrinogenemia(PRR=1267. 48), and non-thrombocytopenic purpura(PRR=1067. 69). In addition, there were also some adverse events with strong signals but not listed in label, such as gallstone intestinal obstruction(PRR=2882. 77) and non-thrombocytopenic purpura(PRR=1067. 69). Conclusion When using tigecycline, medical staffs should not only pay colser attention to adverse events already recorded in the drug’s instructions such as hypofibrinogenemia, but also closely monitor adverse events with strong signal not yet listed in the instructions, such as gallstone intestinal obstruction, to ensure the safety and efficacy of the drug use for patients.更多还原