摘要
目的:挖掘托法替布相关不良事件的风险信号,为临床安全使用提供参考。方法:采用报告比值法和比例报告比值法2种方法挖掘美国FDA不良事件数据库中托法替布相关风险信号(2012年11月8日—2020年12月31日)。对报告数排名前50位、阳性信号强度排名前50位以及致死报告数前10位的不良事件进行统计分析。结果:共收集托法替布相关不良事件报告数83184例,女性患者报告数约为男性患者4.23倍(77.53%vs 18.31%),老年患者(≥60岁)比成年患者(18~59岁)多(43.84%vs 32.86%)。报告数排名前50位的不良事件主要累及:感染及侵染类疾病(9个)、胃肠道系统疾病(8个)、全身性疾病及给药部位的反应(7个)等。阳性信号强度排名前50位的不良事件主要累及:感染及侵染类疾病(13个),良性、恶性及性质不明的肿瘤(9个),各类检查(6个)等。致死报告数排名前3位的不良事件分别是:感染性肺炎87例(5.02%)、间质性肺疾病45例(2.60%)、脓毒症45例(2.60%)。结论:本研究收集了托法替布真实世界不良事件数据,共发现39个说明书未详细记载的不良事件,对该药在临床安全合理使用具有重要提示作用,也为将来说明书补充修改提供参考。
Objective:To provide reference for clinical safety by mining the risk signals of tofacitinib-associated adverse events.Methods:The reporting odds ratio(ROR)and proportional reporting ratio(PRR)were used to detect the risk signals related to tofacitinib in the US FDA Adverse Event Reporting System(2012.11.08 to 2020.12.31).The adverse event of top 50 reports,top 50 signal strength and top 10 fetal reports were analyzed.Results:A total of 83184 reports of tofacitinib-associated adverse events were collected.The number of female patients was 4.23 times of the number of male patients(77.53%vs 18.31%),and elderly patients(≥60 years old)were more than adult patients(18~59 years old)(43.84%vs 32.86%).The top 50 reported adverse events mainly involved infections and infestations(9),gastrointestinal disorders(8),general disorders and administration site conditions(7),etc.The top 50 signal strength adverse events mainly involved infections and infestations(13),neoplasms benign,malignant and unspecified(9),investigations(6),etc.The top 3 fatal adverse events were pneumonia(87,5.02%),interstitial lung disease(45,2.60%),sepsis(45,2.60%).Conclusion:This study collected real-world adverse event data of tofacitinib and found 39 adverse events uncovered by the label,which can provide reference for the safe application and benefit the supplement of the label in the future.
作者
韩强
潘晨
郑明伟
孙一琦
尹航
董瑞华
沈素
HAN Qiang;PAN Chen;ZHENG Ming-wei;SUN Yi-qi;YIN Hang;DONG Rui-hua;SHEN Su(Department of Clinical Laboratory,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Department of Pharmacy,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Inpatient Internal Medicine II Ward,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Research Ward,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第11期1125-1131,共7页
Chinese Journal of New Drugs
基金
中国毒理学会临床毒理专项:严重药源性疾病流行情况研究(CST2020CT301)。
