基于FAERS数据库的PCSK9抑制剂不良事件性别差异信号挖掘与分析

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【中图分类号】R95 【文献标识码】A

【Abstract】 Objective To explore the gender distribution of adverse drug event （ADE） signals of proprotein convertase subtilisin/kexin type 9 （PCSK9） inhibitors （alirocumab， evolocumab and inclisiran）， and to provide reference for individualized safe medication in different genders.Methods The reports of the drugs mentioned above from the first quarter of2022 to the first quarter of 2024 were extracted from the U.S.Food and Drug Administration Adverse Events Reporting System （FAERS） database.The reporting odds ratio （ROR） method and composite criteria method from Medicines and Healthcare Products Regulatory Agency were used to mine and analyse the signals. Results All3 PCSK9 inhibitors had more reported cases of ADE in women than in men，and a greater proportion of elderly patients in women relative to men.Signal testing revealed that men were more likelyto have injection sites-related ADEs with alirocumab，and muscle-related ADEs and elevated lipoprotein a with inclisiran. While for women， using alirocumab or evolocumab was more likely to cause cardiovascular adverse events，and using inclisiran was more likely to cause a decrease in low-density lipoprotein or in triglycerides. Conclusion There are gender-specific diferences in the ADE signals of PCSK9 inhibitors. Clinical usecan refer to the signals of high-risk ADEs that may occur after drug use by diffrent genders，targeting the identification of adverse drug events and exploring the possibility of gender-individualized treatment.

【Keywords】PCSK9 inhibitor; Signal mining; Gender distribution; Adverse drug events

低密度脂蛋白胆固醇（lowdensity lipoproteincholesterol，LDL-C）水平是动脉粥样硬化性心血管疾 病（atherosclerotic cardiovascular disease，ASCVD）的致病性危险因素。（剩余13000字）