目的 基于日本藥物不良事件報告（JADER）數(shù)據(jù)庫對莫諾拉韋有關(guān)藥品不良事件（ADE）信號進(jìn)行檢測，為莫諾拉韋的臨床安全使用提供參考。方法 采用報告比值比（ROR）法和綜合標(biāo)準(zhǔn)（MHRA）法對JADER數(shù)據(jù)庫中自2004年4月—2023年3月的莫諾拉韋相關(guān)ADE報告進(jìn)行數(shù)據(jù)挖掘。結(jié)果 共篩選得到莫諾拉韋ADE報告550份。其中，女性占比43.09%，男性占比為48.73%，男女性別比1.13∶1，55歲及以上人群占比為81.82%。共發(fā)現(xiàn)ADE信號32個，涉及12個系統(tǒng)器官分類（SOC）。ADE信號主要集中在感染及侵染類疾病、全身性疾病及給藥部位各種反應(yīng)、胃腸系統(tǒng)疾病、皮膚及皮下組織類疾病和各類檢查等。其中COVID-19肺炎、COVID-19、單側(cè)耳聾和誤吸等ADE信號較強(qiáng)。結(jié)論 本研究新發(fā)現(xiàn)的ADE信號對藥品說明書中現(xiàn)有的安全性信息提供了有益補(bǔ)充，提示醫(yī)務(wù)人員應(yīng)加強(qiáng)對相關(guān)ADE的監(jiān)測、干預(yù)和臨床救治，保障患者用藥安全。

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.

R978.7

許昌市重點研發(fā)與推廣專項（科技攻關(guān)、軟科學(xué)研究）備案項目（20220213033）