基于JADER的莫诺拉韦不良事件信号检测与分析

Signal detection and analysis of adverse events related to molnupiravir based on Japanese Adverse Drug Event Report database

目的 基于日本药物不良事件报告(JADER)数据库对莫诺拉韦有关药品不良事件(ADE)信号进行检测,为莫诺拉韦的临床安全使用提供参考。方法 采用报告比值比(ROR)法和综合标准(MHRA)法对JADER数据库中自2004年4月—2023年3月的莫诺拉韦相关ADE报告进行数据挖掘。结果 共筛选得到莫诺拉韦ADE报告550份。其中,女性占比43.09%,男性占比为48.73%,男女性别比1.13∶1,55岁及以上人群占比为81.82%。共发现ADE信号32个,涉及12个系统器官分类(SOC)。ADE信号主要集中在感染及侵染类疾病、全身性疾病及给药部位各种反应、胃肠系统疾病、皮肤及皮下组织类疾病和各类检查等。其中COVID-19肺炎、COVID-19、单侧耳聋和误吸等ADE信号较强。结论 本研究新发现的ADE信号对药品说明书中现有的安全性信息提供了有益补充,提示医务人员应加强对相关ADE的监测、干预和临床救治,保障患者用药安全。

Objective To detect and analyze the adverse events signal related to molnupiravir based on Japanese Adverse Drug Event Report database in order to provide references for the safely clinical use of molnupiravir. Methods The signal value of adverse drug events (ADE) related to molnupiravir in Japanese Adverse Drug Event Report database from April 2004 to March 2023 until now was calculated by using reporting odds ratio (ROR) method and Medicines and Healthcare Products Regulatory Agency (MHRA) method. Results A total of 550 ADE reports related to molnupiravir were searched out, in which the proportion of female was 43.09%, the proportion of male was 48.73%, the male to female ratio was 1.13:1, the proportion of people aged 55 and above was 81.82%. 32 ADE signals related 12 system organs class (SOC) were founded, which were mainly distributed in infections and infestations, general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders and investigations. ADEs such as COVID-19 pneumonia, COVID-19, deafness unilateral and aspiration showed strong signals. Conclusion The newly founded ADE signals in this study provided a useful supplement to the safety information recorded in the instruction which enlightened the medical stuff that proper monitoring, intervention and clinical treatment to relevant ADEs should be strengthened to ensure the safety of patients.