基于OpenFDA数据库挖掘与评价巴瑞替尼上市后的不良反应  

Analysis of post-marketing adverse drug reactions of baricitinib based on OpenFDA database

作　　者：孙璇 张科[1] 袁恒杰[1] 李正翔[1] SUN Xuan;ZHANG Ke;YUAN Hengjie;LI Zhengxiang(Department of Pharmacy,Tianjin Medical University General Hospital,Tianjin 300052,China)

机构地区：[1]天津医科大学总医院药剂科,天津市300052

出　　处：《临床合理用药杂志》2023年第26期36-40,共5页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的基于美国食品药品监督管理局公共数据公开项目(OpenFDA)数据库,挖掘与评价巴瑞替尼上市后的药品不良反应(ADR)风险信号,为临床安全用药提供依据。方法采用报告比值比(ROR)法对2017年2月13日—2021年12月31日OpenFDA数据库中巴瑞替尼ADR报告数据进行风险信号挖掘,挖掘得到的信号采用《国际医学用语词典》中首选系统器官分类(SOC)和首选术语(PT)进行统计分类和分析。结果检索到巴瑞替尼ADR报告3265例,挖掘到40个具有临床参考价值的ADR风险信号,主要涉及感染及侵染类疾病、血液和淋巴系统疾病、全身性疾病及给药部位的各种反应、肝胆系统疾病、呼吸系统疾病、心脏疾病、代谢和营养类疾病7个系统器官。巴瑞替尼除说明书载入的不良反应外,还存在C反应蛋白升高、血氧饱和度下降、败血症及呼吸衰竭4个说明书未提及的阳性风险信号。结论临床应用巴瑞替尼时,除药品说明书中已提到的不良反应外,还需密切关注其C反应蛋白升高、血氧饱和度下降、败血症及呼吸衰竭等风险,避免因此类不良反应带来的损害。Objective Based on the OpenFDA database of the U.S.Food and Drug Administration,to explore and evaluate the risk signals of adverse drug reactions(ADR)after the introduction of baritinib to the market,and to provide basis for clinical safe drug use.Methods The report odds ratio(ROR)method was used to mine the risk signal of adverse reaction report data of baretinib in the public OpenFDA database from February 13,2017 to December 31,2021,the mined signals were statistically classified and analyzed by using the preferred system organ classification(SOC)and preferred term(PT)of the International Dictionary of medical terms.Results 3265 adverse reaction reports related to baretinib were retrieved,and 40 adverse reaction risk signals with clinical reference value were excavated,mainly involving 7 system organs,including metabolic and nutritional diseases,hepatobiliary diseases,infectious and infectious diseases,respiratory diseases,systemic diseases and various reactions at the administration site,heart diseases,blood and lymphatic diseases.It was found that in addition to the adverse reactions contained in the instructions,there were four positive risk signals not mentioned in the instructions,such as increased C reactive protein,decreased blood oxygen saturation,sepsis and respiratory failure.Conclusion In addition to the adverse reactions mentioned in the drug instructions,it is also necessary to pay close attention to the risks of increased C reactive protein,decreased blood oxygen saturation,sepsis and respiratory failure,so as to avoid the damage caused by these adverse reactions.

关 键 词：巴瑞替尼 美国食品药品监督管理局公共数据公开项目 药品不良反应 报告比值比 

分 类 号：R969[医药卫生—药理学]