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.
Abstract
OBJECTIVE By mining and evaluating the safety signals of Molnupiravir after its marketing,an an-ti-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 health-care 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 phase Ⅲclinical 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,ap-propriate prevention and intervention measures should be taken in time to reduce the occurrence of drug injury events.
维普
万方数据