目的 基于日本药品不良事件报告（JADER）数据库对美洛加巴林药物不良事件风险信号进行挖掘和分析，为该药临床使用的安全性提供参考。方法 采用报告比值比（ROR）法和综合标准法（MHRA）对日本JADER数据库中2004年4月—2024年12月美洛加巴林上报的不良事件进行挖掘和分析。结果 最终得到39个有关美洛加巴林的信号，涉及12个SOC分类。主要包括各类神经系统疾病（40.85%），全身性疾病及给药部位各种反应（11.59%），肾脏及泌尿系统疾病（11.59%）等。其中，有18个信号未被药品说明书收载，占总数的48.72%，主要包括肾功能损害和急性肾损伤、心力衰竭、横纹肌溶解等。结论 检测出美洛加巴林新的不良事件信号对药品说明书现有的安全性信息提供了补充。治疗期间应密切监测患者神经系统症状、肾功能和心功能等指标，及时做出干预。

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

杭州市医药卫生科技项目（A20230089）