奈玛特韦片/利托那韦片不良事件信号挖掘

Data mining for adverse events signals of nirmatrelvir/ritonavir

目的利用COVID-19紧急使用授权FDA不良事件报告系统(FAERS)数据库挖掘奈玛特韦片/利托那韦片的安全警戒信号,检测和识别潜在的药物不良反应信号,以期为奈玛特韦片/利托那韦片的临床应用提供参考。方法采用比例失衡分析法中的报告比值比法(ROR),检索FAERS数据库建库至2022年12月31日所有关于奈玛特韦片/利托那韦片的不良事件报告,挖掘不良事件信号。利用国际医学用语词典术语集进行汉化及分析查询。结果共收到奈玛特韦片/利托那韦片为首要可疑药物的ADE报告24000份,占数据库报告总数的43.25%(24000/55488),累及13个系统器官,其中占比居前3位的系统器官依次为全身性疾病及给药部位各种反应(26.16%)、感染及侵染类疾病(18.31%)和各类神经系统疾病(13.83%)。以ROR值排序,相关性前3位的风险信号为疾病复发(ROR=122.20,95%CI:116.29~128.42);味觉倒错(ROR:45.14,95%CI:42.79~47.62)和症状重复出现(ROR=18.74,95%CI:16.50~21.28),其比例明显高于其他COVID-19治疗药物。结论奈玛特韦片/利托那韦片的严重不良事件风险较低,但应注意其与疾病复发的关联。在临床应用时,需要关注血管与淋巴管疾病等未提及的不良事件信号,并评估潜在的相互作用。

Objective To detect and identify the safety warning signals of nematovir/litonavir tablets by mining the data in the COVID-19 Emergency Use Authorization(EUA)FDA Adverse Event Reporting System(FAERS)Public Dashboard data⁃base,so as to provide references for the clinical application of nematovir/litonavir tablets.Methods The reporting odds ratio(ROR)method in the proportion imbalance analysis method was used to search all the adverse event reports of nematovir/litonavir tablets were retrievend from the FAERS database until December 23,2022,and the adverse event were mined.The glossary of the International Dictionary of Medical Terms was used for Chinesization and analysis.Results FAERS database had received 24000 ADE reports of nematovir/litonavir tablets as the primary suspect drug,accounting for 43.25%(24000/55488)of the total number of database reports,involving 13 system organs.The top two system organs were systemic dis⁃eases and various reactions at the drug administration site(26.16%),infection and infectious diseases(18.31%)and vari⁃ous nervous system diseases(13.83%).Ranked by ROR value,the first three risk signals of correlation were disease recur⁃rence(ROR:122.20,95%CI:116.29-128.42),taste inversion(ROR:45.14,95%CI:42.79-47.62)and repeated oc⁃currence of symptoms(ROR:18.74,95%CI:16.50-21.28),the proportions of which were significantly higher than those of other COVID-19 therapeutic drugs.Conclusion The risk of severe adverse events associated with the use of nematovir/litonavir tablets is low,but its association with disease relapse should not be ignored.During clinical application,it is neces⁃sary to pay attention to adverse event signals such as vascular and lymphatic disorders that are not mentioned in the instruc⁃tions,and evaluate potential interactions.