摘要
目的挖掘并评价氟维司群的药品不良反应(ADR)信号,为临床安全用药提供参考。方法收集美国食品和药物管理局不良事件报告系统(FAERS)中2013年第一季度至2021年第二季度的数据,采用报告比值比(ROR)法、比例报告比值(PRR)法挖掘氟维司群ADR信号。结果ROR法和PRR法分别检出362个和338个有效的ADR信号,所得信号强度(即ROR值和PRR值)基本重合。经二次筛选后得到信号204个,其中新ADR信号191个,主要集中在良性、恶性及性质不明的肿瘤(包括囊状和息肉状,32个),各类检查(27个),全身性疾病及给药部位各种反应(24个),各类神经系统疾病(12个),血管与淋巴管类疾病(11个)。信号强度(由高到低排列)排名前5的首选术语分别为PIK3CA活化性突变、CA15-3升高、雌二醇升高、胸壁转移、胸腔转移。结论临床应重视该研究中通过ROR法、PRR法检测的氟维司群药品说明书中未提及的新的ADR信号,促进氟维司群安全使用。
Objective To mine and evaluate the signals of adverse drug reaction(ADR)induced by fulvestrant,and to provide a reference for clinical safe medication.Methods The data from the first quarter of 2013 to the second quarter of 2021 in the Food and Drug Administration's(FDA's)Adverse Event Reporting System(FAERS)were collected,and the reported odds ratio(ROR)method and proportional reporting ratio(PRR)method were adopted to mine the ADR signal of fulvestrant.Results A total of 362 effective ADR signals were detected by the ROR method and 338 effective ADR signals were detected by the PRR,and the signal intensity(ROR value and PRR value)was basically the same.After the second screening,204 signals were obtained,including 191 new ADR signals,which were mainly concentrated in benign,malignant and unknown tumors(including cystic and polypoid tumors,n=32),various examinations(n=27),systemic diseases and various reactions at the site of administration(n=24),various neurological diseases(n=12),and vascular and lymphatic diseases(n=11).The top five preferred terms of signal intensity(from high to low)were PIK3CA activating mutation,CA15-3 elevation,estradiol elevation,chest wall metastasis,and thoracic metastasis.Conclusion Clinical attention should be paid to the new ADR signals detected by ROR and PRR methods in this study,which are not mentioned in the package insert of fulvestrant,so as to promote the safe use of fulvestrant.
作者
刘泽玉
陈润
王洪贵
郑咏池
陈凤玲
LIU Zeyu;CHEN Run;WANG Honggui;ZHENG Yongchi;CHEN Fengling(Dujiangyan People's Hospital,Chengdu,Sichuan,China 611830;Dujiangyan Hospital of Traditional Chinese Medicine,Chengdu,Sichuan,China 611830)
出处
《中国药业》
CAS
2022年第18期107-111,共5页
China Pharmaceuticals
基金
广东省药理学会药物警戒联盟研究课题[GDPSPA-XY20190007]。
