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目的:挖掘低氧诱导因子脯氨酰羟化酶抑制剂（HIF-PHI）类药物不良事件（AE）风险信号，为临床安全使用该类药物提供参考。方法:检索美国FDA不良事件报告系统数据库2004年1月1日至2023年9月30日收到的HIF-PHI类药物的AE报告，采用《国际医学用语词典》25.0版系统器官分类（SOC）和首选术语（PT）对AE进行分类和标准化。采用报告比值比（ROR）法挖掘上述药物的风险信号。将AE报告数≥3、 ROR值95%置信区间下限>1的PT定义为风险信号，并进行描述性分析。 结果:仅收集到罗沙司他、达普司他和伐达度司他的AE报告数据。收集到罗沙司他AE报告78例，涉及12个PT和8个SOC。信号强度居前5位的PT依次为分流管阻塞、中枢性甲状腺功能减退、胃肠穿孔、结肠癌和肝功能异常；除中枢性甲状腺功能减退外，其他4个均为说明书未记载的不良事件。收集到达普司他AE报告459例，涉及29个PT和13个SOC。信号强度居前5位的PT依次为胃肠道溃疡、视网膜出血、直肠出血、粪便异常和结肠癌，其中视网膜出血、粪便异常和结肠癌为说明书中未记载的不良事件。收集到伐达度司他AE报告26例，涉及6个PT和4个SOC。信号强度居前5位的PT依次为药疹、脸部水肿、结肠癌、胃肠出血、脱水，5个PT均为说明书未记载的不良事件。结论:罗沙司他、达普司他和伐达度司他的风险信号说明书多未记载，如分流管阻塞、胃肠穿孔、视网膜出血等。临床医师使用上述3种药物时，除应关注药品说明书中记载的不良反应外，还应警惕药品说明书未记载的不良事件。

Objective:To mine the risk signals of hypoxia-inducible factor prolyl hydrocylase inhibitor (HIF-PHI)-related adverse events (AEs) and provide reference for the safe use of the drugs in clinic practice.Methods:AE reports of HIF-PHI drugs were collected from the US FDA Adverse Event Reporting System (FAERS) database during January 1, 2004 to September 30, 2023. AEs were classified and standardized according to the system organ class (SOC) and the preferred term (PT) in Medical Dictionary for Regulatory Activities 25.0. The AE risk signals of above mentioned 3 drugs were mined using reporting odds ratio (ROR) method. An AE with reports ≥3 and the lower limit of the 95% confidence interval ( CI) of ROR >1 was defined as a risk signal. Descriptive analysis on the signals was performed. Results:Only AE report data for roxadustat, daprodustat, and vacladustat were collected. A total of 78 AE reports related to roxadustat were collected, involving 12 PTs and 8 SOCs. The top 5 PTs in signal intensity were shunt occlusion, central hypothyroidism, gastrointestinal perforation, colon cancer, and hepatic function abnormal. Except for central hypothyroidism, the other 4 were not recorded in the labels. A total of 459 AE reports related to daprodustat were collected, involving 29 PTs and 13 SOCs. The top 5 PTs in signal intensity were gastrointestinal erosion, retinal haemorrhage, haemorrhoidal haemorrhage, abnormal feces and colon cancer. Retinal haemorrhage, abnormal feces and colon cancer were new adverse events not recorded in the labels. A total of 26 AE reports related to vadadustat were collected, involving 6 PTs and 4 SOCs. The top 5 PTs in signal intensity were drug eruption, face oedema, colon cancer, gastrointestinal haemorrhage, and dehydration, all of which were new adverse event not recorded in the labels.Conclusions:The risk signals of roxadustat, daprodustat and vadadustat are mostly adverse events not recorded in the labels, such as shunt obstruction, gastrointestinal perforation, colon cancer, etc. When using the 3 drugs, clinicians should not only pay attention to the adverse reactions recorded in the labels, but also be alert to the adverse events not recorded in the labels.