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目的:挖掘洛匹那韦/利托那韦（LPV/r）不良事件（AE）的风险信号，探讨LPV/r的临床安全性，为该药在新型冠状病毒肺炎（COVID-19）治疗中的安全应用提供参考。方法:采用报告比值比法（n ROR）对美国食品药品管理局不良事件报告系统（FAERS）2010年第1季度至2019年第3季度AE报告数据中LPV/r相关的风险信号进行挖掘，检测阈值为报告数大于3且n ROR的95%置信区间（n CI）下限大于1的AE，并对AE采用国际医学用语词典（MedDRA）的首选系统器官分类（SOC）和首选术语（PT）进行统计和分类，选取AE报告数和信号强度排名前50位的PT进行分析。n 结果:2010年第1季度至2019年第3季度FAERS数据库共收到LPV/r为首要可疑药物的AE报告13 335例，检测出报告数>3且n ROR的95n %CI下限>1的AE风险信号455个，涉及AE报告7 718例。涉及AE报告数占比居前2位的系统器官依次为“各类损伤、中毒及手术并发症”[13.6%（1 051/7 718）]和“妊娠期、产褥期及围产期状况”[11.7%（899/7 718）]，但在“各类损伤、中毒及手术并发症”所涉及的1 051例AE报告中与妊娠期药物暴露有关者为998例，占95.0%；信号数占比居首位的系统器官为“各种先天性家族遗传性疾病”[16.3%（74/455）]。另外，药物相互作用所致AE共144例，在AE报告数中排第7位。n 结论:检测出LPV/r妊娠期用药相关胎儿、新生儿和婴儿异常等风险信号，提示应关注孕妇和婴幼儿使用LPV/r的风险。LPV/r与其他药物联用时的相互作用也值得关注。“,”Objective:To explore the clinical safety of lopinavir/ritonavir (LPV/r) by mining the risk signals of adverse events (AEs) related to LPV/r for the safe application of the drug in the treatment of novel coronavirus pneumonia (COVID-19).Methods:The risk signals related to LPV/r in AE reports of US FDA Adverse Event Reporting System (FAERS) from the first quarter of 2010 to the third quarter of 2019 were mined by reporting odds ratio (n ROR). An AE with reports more than 3 and 95% confidence interval (n CI) lower limit of n ROR greater than 1 was defined as a positive signal. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA). The PTs of top 50 adverse event reports and signal strength were selected and analyzed.n Results:From the first quarter of 2010 to the third quarter of 2019, a total of 13 335 AE reports with LPV/r as the primary suspicious drug were reported in the FAERS database. Four hundred and fifty-five AE risk signals with reports more than 3 and the 95n %CI lower limit of n ROR greater than 1 were detected, involving 7 718 AE reports. The top 2 system organs involved in AE reports were “injury, poisoning and procedural complications” [13.6% (1 051/7 718)] and “pregnancy, puerperium and perinatal conditions” [11.7% (899/7 718)]. However, 998 (95.0%) of 1051 AE reports involved in “injury, poisoning and procedural complications” were related to drug exposure during pregnancy. The system organ with the highest signals was “congenital, familial and genetic disorders” [16.3% (74/455)]. In addition, 144 AEs caused by drug interactions were detected, which ranked the 7th in the AE reports.n Conclusions:The risk signals of fetal, neonatal and infant abnormalities related to LPV/r during pregnancy were detected, suggesting that attention should be paid to the risk of using LPV/r in pregnant women and infants. The interaction between LPV/r and other drugs was also worthy of attention.