基于openFDA对地加瑞克安全信号的挖掘与分析

Data mining and analysis for safety signals of degarelix based on openFDA

目的挖掘和评价前列腺癌治疗药物地加瑞克上市后的安全信号,为临床安全用药提供参考。方法检索美国食品药品管理局公共数据开放项目(openFDA)2004年1月1日—2021年11月4日收录的地加瑞克不良事件(ADE)报告,采用报告比值比法和信息成分法对ADE信号进行检测,利用国际医学用语词典对ADE进行系统归类和安全评估。结果在限定的检索时间段内,共提取到以地加瑞克为怀疑药物的ADE报告4663份,其中严重ADE占51.30%。挖掘出阳性风险信号35个,共涉及9个系统/器官。基于系统/器官分类,全身性及给药部位ADE产生的阳性信号最多,占57.14%。比例失衡测量法显示,全身性及给药部位,各类检查以及各类肌肉骨骼和结缔组织疾病相关ADE产生的信号强度均较高。结论应用地加瑞克时,应警惕严重ADE的发生,重点关注给药部位ADE,同时还应关注前列腺特异性抗原及ALT升高,肌肉骨骼疼痛以及心血管事件的发生。

Objective To provide reference for clinical drug safety,the postmarketing safety signals of degarelix for prostate cancer were explored and evaluated.Methods Adverse drug events(ADE)reports of degarelix from January 1,2004 to November 4,2021 were extracted from the database of the US Food and Drug Administration Public Data Open Project(openFDA).ADE signals were detected and analyzed by using reporting odds ratio(ROR)and information component(IC).The systems involved in ADEs were classified and evaluated through Medical Dictionary for Drug Regulatory Activities(MedDRA).Results During the limited search period,4663 ADE reports with degarelix as the suspected drug were extracted,and serious adverse events accouted for 51.30%.35 ADE risk signals related to degarelix were mined,involving 9 organs or systems.Based on system organ classification(SOC),the number of positive signals exerted by general disorders and administration site ADE was largest and accounted for 57.14%.Disproportionality analyses showed ADEs induced by general disorders and administration site,investigations,and musculoskeletal and connective tissue disorders exhibited high signal strength.Conclusion When took degarelix,more attention should be paid to the serious ADEs,especially the ADEs for the administration site.Meanwhile,the attention should also be paid to the increase of PSA and ALT,musculoskeletal pain and cardiovascular events.