干扰素β-1a治疗新型冠状病毒感染的不良反应事件分析  

Safety of interferon β-1a for treatment of COVID-19:a real-world study based on FAERS database

作　　者：杨蓉青 高永晴 胡方圆 翟映红 王奎玲 陆畅 贺佳 张海英[1] YANG Rongqing;GAO Yongqing;HU Fangyuan;ZHAI Yinghong;WANG Kuiling;LU Chang;HE Jia;ZHANG Haiying(School of Public Health,Guangxi Medical University,Nanning,Guangxi 530021,China;School of Medicine,Tongji University,Shanghai 200092,China;Naval Hospital of Eastern Theater,Zhoushan,Zhejiang 316004,China;Department of Reception and Follow-up,Tianjin Rehabilitation and Recuperation Center,Joint Logistics Support Force of Chinese People's Liberation Army,Tianjin 300110,China;Tianjin Medical University,Tianjin 300070,China;Department of Medical Statistics,Faculty of Medical Services,Naval Medical University,Shanghai 200433,China)

机构地区：[1]广西医科大学公共卫生学院,广西南宁530021 [2]同济大学医学院,上海200092 [3]东部战区海军医院,浙江舟山316004 [4]中国人民解放军联勤保障部队天津康复疗养中心接诊随访科,天津300110 [5]天津医科大学,天津300070 [6]海军军医大学卫生勤务学系卫生统计学教研室,上海200433

出　　处：《上海预防医学》2023年第6期549-554,共6页Shanghai Journal of Preventive Medicine

基　　金：国家重点研究开发资助项目(2017YFC0908000);国家自然科学基金资助项目(82160158,81760145);广西自然科学基金资助项目(2017GXNSFDA198032)。

摘　　要：【目的】系统评价干扰素β-1a治疗新型冠状病毒感染(COVID-19)的安全性,为临床安全用药提供参考借鉴。【方法】应用信息成分法(IC)和报告比值法(ROR)对2015年1月1日—2021年3月31日美国食品药品监督管理局不良事件报告系统(FAERS)数据库中的数据进行信号挖掘。【结果】挑选出463 700条COVID-19相关记录进行分析,共发现45个干扰素β-1a相关不良事件的不相称测定信号。头痛(IC_(025)=1.09,ROR_(025)=2.28)、发热(IC_(025)=0.51,ROR_(025)=1.51)和多发性硬化复发(IC_(025)=3.67,ROR_(025)=14.71)等是不相称测定信号频数较高的不良事件。自身免疫疾病(IC_(025)=4.42,ROR_(025)=24.03)、链球菌感染(IC_(025)=4.12,ROR_(025)=19.82)和多发性硬化复发(IC_(025)=3.67,ROR_(025)=14.71)等是信号强度较高的不良事件。急性肺损伤、心脏呼吸骤停和代谢性酸中毒等不良事件对应的死亡比例和死亡频数较高。【结论】干扰素β-1a治疗COVID-19存在着一定的安全性问题,医务人员须重视部分频数和死亡比例高的不良事件。[Objective]To systematically evaluate the safety of interferonβ-1a for treatment of corona virus disease 2019(COVID-19),and to provide references for interferonβ-1a's clinical application.[Methods]This study was conducted with the database from US Food and Drug Administration adverse event reporting system(FAERS)from January 1,2015 to March 31,2021.Information component(IC)and reporting odds ratio(ROR)methods were applied for signal mining.[Results]A total of 463700 records of COVID-19 were selected for analysis,and 45 positive drug adverse event signals were detected.Headache(IC_(025)=1.09,ROR_(025)=2.28),pyrexia(IC_(025)=0.51,ROR_(025)=1.51)and multiple sclerosis relapse(IC_(025)=3.67,ROR_(025)=14.71)were positive adverse events with higher frequency.Autoimmune disorder(IC_(025)=4.42,ROR_(025)=24.03),streptococcal infection(IC_(025)=4.12,ROR_(025)=19.82),and multiple sclerosis relapse(IC_(025)=3.67,ROR_(025)=14.71)were positive adverse events.Acute lung injury,cardio-respiratory arrest and metabolic acidosis were associated with a higher proportion and frequency of death.[Conclusion]There are certain safety issues with interferonβ-1a in the treatment of COVID-19,and some adverse events with high frequency and high death rate deserve further attention by medical staffs.

关 键 词：干扰素β-1a 新型冠状病毒感染 信息成分法 报告比值法 药品不良事件 

分 类 号：R18[医药卫生—流行病学]