基于FAERS的巴瑞替尼药品不良反应信号挖掘

目的 促进巴瑞替尼的临床合理、安全用药.方法 采用报告比值比(ROR)法和比例报告比值(PRR)法对美国食品药物管理局不良事件报告系统中2018年第2季度至2020年第4季度巴瑞替尼药品不良反应(ADR)报告进行数据挖掘.结果 得到ADR报告总数15480927份,其中首要怀疑药物为巴瑞替尼的报告数4173份.共挖掘A...

Data Mining for Adverse Drug Reaction Signals Induced by Baricitinib Based on FAERS

Objective To promote the clinical rational and safe use of baricitinib.Methods The report odds ratio(ROR)method and proportional reporting ratio(PRR)were used to conduct data mining for the adverse drug reaction(ADR)reports of baricitinib in the FDA adverse events reporting system(FAERS)from the second quarter of 2018 to the fourth quarter of 2020.Results A total of 15480927 ADR reports were obtained,including 4173 reports that the primary suspected drug was baricitinib.A total of 1162 ADR signals were mined,and 146 ADR signals of baricitinib were finally obtained by the secondary screening.A total of 16 organ/system classifications were involved with 75 new ADR signals.The top three organ/system classifications of baricitinib in the number of ADR signals were infectious diseases,respiratory system,chest and mediastinal diseases,benign,malignant and unknown diseases.The top three preferred terms in the number of ADR reports were pulmonary embolism,herpes zoster and deep venous thrombosis,and the top three ADR signals in the terms of signal intensity were diffuse large B-cell lymphoma stageⅣ,herpes zoster meningitis and tuberculous pleurisy.The largest number of reported ADR cases occurred in Europe,followed by Asia and North America.The incidence of ADR in women was higher than that in men,and that in the age≥45 years old was the most(76.40%).ADR was mainly induced by the dosage of 2 mg/d and 4 mg/d,and the duration of 31-180 d(24.03%).The main clinical outcome of ADR was prolonged hospitalization.Conclusion During the use of baricitinib,we should not only pay attention to the common ADR,but also pay attention to the new ADR signals not involved in the drug instructions.During medication,we should pay close attention to the serious respiratory tract,skin infection and embolism,and take corresponding preventive measures in time to avoid the occurrence of serious ADR.