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Pharmacy Information 2024
基于FAERS对瑞卢戈利安全信号的挖掘与分析
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Abstract:
目的：挖掘瑞卢戈利的安全警戒信号，研究瑞卢戈利上市后真实世界的安全性。方法：基于FAERS对瑞卢戈利2019年1月至2023年8月期间的不良事件(ADE)数据，通过比例失衡法中的报告比值比(ROR)法与比例报告比值比(PRR)法对数据进行挖掘分析。结果：检索到相关瑞卢戈利ADE报告2308例，具有临床参考意义的不良反应风险信号28个，累及11个系统器官，其中19个新信号瑞卢戈利说明书中未提及。结论：在瑞卢戈利临床使用中，应加强对肌肉–骨骼肌系统疾病、全身性疾病及给药部位各种反应、血管及淋巴管类疾病以及心血管系统疾病下属ADE的关注度，重视说明书中未提及的血睾酮升高、间质出血等较强的ADE。
Objective: To mine the safety warning signals of relugolix based on the FAERS, and to study the real-world safety of relugolix after its launch. Methods: The adverse event data of relugolix from January 2019 to August 2023 in FAERS database were collected. The reported odds ratio (ROR) method and proportional reporting odds ratio (PRR) method in the proportional imbalance method were used to mine and analyze the data. Results: A total of 2308 ADR reports of relugolix were retrieved, and 28 risk signals of adverse reactions with clinical reference significance were identified, involving 11 systems and organs. Compared with relugolix’s instructions, 19 were not mentioned. Conclusion: In the clinical use of relugolix, attention should be paid to ADRs associated with musculoskeletal system disorders, general disorders and administration site conditions, vascular disorders and cardiovascular system disorders. More attention should be paid to ADR with strong signals such as blood testosterone increased and intermenstrual bleeding, which are not mentioned in the instructions.
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