抗新冠病毒药物莫诺拉韦真实世界安全信号的挖掘与评价  

Mining and Evaluation of Real World Safety Signals of the Novel Anti-coronavirus Drug Molnupiravir

作　　者：李飞 赵娇娇 LI Fei;ZHAO Jiao-jiao(Department of Pharmacy,Fujian provincial hospital,Fuzhou 350001,China;School of Pharmacy,Guizhou University,Guizhou 550025,China)

机构地区：[1]福建省立医院药学部,福建福州350001 [2]贵州大学药学院,贵州贵阳550025

出　　处：《海峡药学》2024年第5期98-103,共6页Strait Pharmaceutical Journal

摘　　要：目的挖掘与评价抗新冠病毒药莫诺拉韦上市后的安全信号,获取真实世界ADE发生情况,对其安全性进行再评价,以期为临床合理用药提供参考。方法借助美国食品药品监督管理局药品不良事件报告系统(FAERS数据库),采用报告比值比法(ROR)挖掘莫诺拉韦安全信号,并对数据进行计算与筛选,对有效风险信号进行再评价。结果收集到截至2022年度莫诺拉韦ADE报告共2118例,男女比例为0.83∶1;年龄大于65岁者占比最高(56.47%);大多疑似ADE报告由医疗保健专业人员提交;报告最多的ADE信号为COVID-19、腹泻、恶心、皮疹、呕吐以及头晕。结论研究发现莫诺拉韦Ⅲ期临床试验外少数潜在和新的不良反应信号,如吞咽困难、黑便、心力衰竭、意识丧失、晕厥等,临床应个体化给药并加强监测,及时采取相应预防和干预措施,降低药害事件的发生。OBJECTIVE By mining and evaluating the safety signals of Molnupiravir after its marketing,an anti-Covid-19 drug,to obtain the ADE occurrence of Molnupiravir in the real world,and to reevaluate its safety,so as to provide reference for clinical rational drug use.METHODS By means of FDA Adverse Event Reporting System(FAERS database),using the reporting odd ratio method(ROR)mine the drug safety signals of Molnupiravir in FAERS database,calculate and screen the data,and re-evaluate the meaningful risk signals.RESULTS A total of 2118 ADEs reports of Molnupiravir up to 2022 were collected,the ratio of male to female was 0.83∶1,the proportion of patients older than 65 years was the highest(56.47%),most suspected ADEs reports were submitted by healthcare professionals;The most commonly reported ADEs signals were COVID-19,diarrhea,nausea,rash,vomiting,and dizziness.CONCLUSION The study based on the FAERS database,showed some new adverse reactions outside the phaseⅢclinical trial of Molnupiravir,such as dysphagia,black stool,heart failure,loss of consciousness,syncope and other signals.The doctors should be based on individual characteristics of patients and strengthen monitoring,appropriate prevention and intervention measures should be taken in time to reduce the occurrence of drug injury events.

关 键 词：莫诺拉韦 COVID-19 不良反应 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]