PCSK9抑制剂不良反应信号的挖掘与评价  

Mining and evaluation of the adverse reaction signals of PCSK9 inhibitors

作　　者：汪静 郑淑芬 钟诗龙 WANG Jing;ZHENG Shu-fen;ZHONG Shi-long(School of Biology and Biological Engineering,South China University of Technology,Guangzhou 510006,China;Guangdong Provincial People′s Hospital,Guangdong Academy of Medical Sciences,Guangzhou 510080,China)

机构地区：[1]华南理工大学生物科学与工程学院,广东广州510006 [2]广东省人民医院(广东省医学科学院),广东广州510080

出　　处：《实用药物与临床》2022年第3期199-204,共6页Practical Pharmacy and Clinical Remedies

基　　金：国家自然科学基金(81872934,81673514);广东省重点领域研发计划(2019B020229003)。

摘　　要：目的挖掘和评价PCSK9抑制剂的药物不良反应信号,为临床合理用药提供理论依据。方法采用报告比值比法和比例报告比值比法对美国食品药品监督管理局不良事件报告系统数据库中2015年第1季度至2020年第3季度PCSK9抑制剂的不良反应信号进行检测与分析。结果纳入以PCSK9抑制剂Evolocumab和Alirocumab为首要怀疑药物的报告共83622份,2种药物检出的ADR信号大致相同,但Evolocumab检出的ADR信号多于Alirocumab。这些ADR信号共涉及21个系统器官分类(SOC),主要体现在给药部位的不良反应、各类检查指标异常、各类损伤、呼吸系统疾病和骨骼肌肉损伤等。结论基于真实世界数据的ADR信号检测证实PCSK9抑制剂的不良反应较轻,其相关安全信息与说明书基本一致,临床应用时需加强监测用药部位的病变,注意各项检查指标的异常,并加强患者的用药教育工作,有助于降低临床用药的风险。Objective To excavate and evaluate the adverse drug reaction signals of PCSK9 inhibitors and provide a theoretical basis for clinical rational drug use.Methods Reporting odds ratio(ROR)and proportional reporting ratio(PRR)were used to detect and analyze the adverse drug reaction signals of PCSK9 inhibitors in the Adverse Event Reporting System of the FDA(FAERS)from the first quarter of 2015 to the third quarter of 2020.Results A total of 83662 reports of PCSK9 inhibitors including evolocumab and alirocumab as the primary suspected drugs were included.The ADR signals excavated by the two drugs were roughly the same,but the number of ADR signals excavated by evolocumab was more than that of alirocumab.The ADR signals involved 21 system organ classifications(SOC),which were mainly reflected in adverse reactions at the administration site,abnormal examination indicators,various injuries,respiratory diseases,and skeletal muscle injuries.Conclusion The ADR signal detection based on real-world data confirms that the adverse reactions of PCSK9 inhibitors are relatively mild,and the relevant safety information is basically consistent with the instructions.In clinical application,it is necessary to strengthen the monitoring of the lesions of the administration site,pay attention to the abnormality of various inspection indicators,and strengthen the patient′s medication education,which helps to reduce the risk of clinical medication.

关 键 词：PCSK9抑制剂 药品不良反应 信号 数据挖掘 安全性 

分 类 号：R95[医药卫生—药学]