目的 基于日本藥品不良事件報(bào)告（JADER）數(shù)據(jù)庫對(duì)美洛加巴林藥物不良事件風(fēng)險(xiǎn)信號(hào)進(jìn)行挖掘和分析，為該藥臨床使用的安全性提供參考。方法 采用報(bào)告比值比（ROR）法和綜合標(biāo)準(zhǔn)法（MHRA）對(duì)日本JADER數(shù)據(jù)庫中2004年4月—2024年12月美洛加巴林上報(bào)的不良事件進(jìn)行挖掘和分析。結(jié)果 最終得到39個(gè)有關(guān)美洛加巴林的信號(hào)，涉及12個(gè)SOC分類。主要包括各類神經(jīng)系統(tǒng)疾?。?0.85%），全身性疾病及給藥部位各種反應(yīng)（11.59%），腎臟及泌尿系統(tǒng)疾?。?1.59%）等。其中，有18個(gè)信號(hào)未被藥品說明書收載，占總數(shù)的48.72%，主要包括腎功能損害和急性腎損傷、心力衰竭、橫紋肌溶解等。結(jié)論 檢測(cè)出美洛加巴林新的不良事件信號(hào)對(duì)藥品說明書現(xiàn)有的安全性信息提供了補(bǔ)充。治療期間應(yīng)密切監(jiān)測(cè)患者神經(jīng)系統(tǒng)癥狀、腎功能和心功能等指標(biāo)，及時(shí)做出干預(yù)。

Objective To identify and analyze risk signals of adverse drug events associated with mirogabalin using the JADER database, assessing its safety and tolerability. Methods Adverse drug events reports for mirogabalin in JADER from April 2004 to December 2024 were analyzed using the ROR and MHRA. Results A total of 39 signals involving 12 SOC classifications were ultimately obtained for mirogabalin. These mainly included nervous system disorders (40.85%), general disorders and administration site conditions (11.59%), renal and urinary disorders (11.59%), etc. Among them, 18 signals were not included in the drug instructions, accounting for 48.72%% of the total, mainly including renal impairment and acute kidney injury, heart failure, and rhabdomyolysis. Conclusion This study identified novel adverse drug events signals associated with mirogabalin, complementing existing safety information. Close monitoring of patients during treatment is recommended to promptly detect and manage neurological symptoms, renal and cardiac function, and other relevant indicators.

R971

杭州市醫(yī)藥衛(wèi)生科技項(xiàng)目（A20230089）