基于FAERS数据库分析PCSK9抑制剂的骨不良反应

Bone adverse reactions of PCSK 9 inhibitors were analyzed based on FAERS database

目的基于FAERS数据库,分析PCSK9抑制剂(依洛尤单抗和阿利西尤单抗)与骨不良反应之间的关联性。方法提取2015—2023年FAERS数据库数据,限定药物角色为首要怀疑,分析PCSK9抑制剂相关的不良反应报告数量及趋势,描述骨不良反应报告的基本特征,采用ROR、PRR和IC等方法进行风险评估。结果依洛尤单抗和阿利西尤单抗不良反应报告中骨不良反应报告分别为64例和13例。依洛尤单抗的女性患者比例显著高于阿利西尤单抗(P<0.05),且消费者报告比例较大。ROR、PRR和IC分析均显示PCSK9抑制剂与骨不良反应无明显关联。结论PCSK9抑制剂与骨不良反应无明显关联,但依洛尤单抗在女性患者中的不良反应报告比例较高,需特别关注其安全性问题。

Objective The association between PCSK9 inhibitors(evolocumab and alirocumab)and bone adverse reactions was analyzed based on the FAERS database.Methods Data from FAERS database from 2015 to 2023 were extracted,and the role of drugs was defined as the primary suspect.The number and trend of adverse reaction reports related to PCSK9 inhibitors were analyzed,and the basic characteristics of bone adverse reaction reports were described.Methods such as ROR,PRR and IC were used for risk assessment.Results Among the adverse reactions reported by evolocumab and alirocumab,64 and 13 cases of bone adverse reactions were reported,respectively.The proportion of female patients with evolocumab was significantly higher than that of aliciumab(P<0.05),and the proportion of consumer reports was larger.ROR,PRR and IC analyses showed no significant association between PCSK9 inhibitors and bone adverse reactions.Conclusion There was no significant association between PCSK9 inhibitors and bone adverse reactions,but a higher proportion of adverse reactions were reported in female patients with evolocumab,and special attention should be paid to its safety.