摘要
目的分析西达本胺片的安全性风险,为临床合理用药提供参考。方法采用比例报告比法和贝叶斯判别可信区间递进神经网络模型,对2014年至2018年国家药品不良反应监测数据库中西达本胺片不良反应/不良事件报告进行数据挖掘,同时对我国药品不良反应监测数据库、国内外文献报道情况及国内外风险控制措施等相关资料进行整理与分析。结果经人工判定及筛选,共得到西达本胺片有价值信号2个,分别为心力衰竭和间质性肺炎。结论应加强抗肿瘤创新药西达本胺片的临床应用监测,及时完善产品说明书,促进药品的合理使用。
Objective To analyze the risk signals of chidamide tablets in China in order to provide reference for clinical rational use of this drug. Methods By using two signal detection methods-PRR and BCPNN, data mining of chidamide tablets was carried out in China adverse drug reaction database between 2014 and 2018. In addition, individual cases of adverse drug reactions documented in China adverse drug reaction database, domestic and foreign literature, and risk management measures in China were analyzed. Results After manual determination and screening, two valuable signals related to chidamide were discovered, namely heart failure and interstitial pneumonia. Conclusion Monitoring of clinical application of chidamide tablets should be enhanced, drug labeling updated without delay and rational application of medicine promoted.
作者
王涛
董铎
熊玮仪
田春华
刘红亮
WANG Tao;DONG Duo;XIONG Weiyi;TIAN Chunhua;LIU Hongliang(Center for Drug Reevaluation,NMPA,Beijing 100022,China)
出处
《中国药物警戒》
2019年第10期614-616,631,共4页
Chinese Journal of Pharmacovigilance
基金
国家科技重大专项项目(2017ZX09101001-001-003)：药品再评价政策法规及实施策略研究
关键词
西达本胺
创新药
心衰
间质性肺炎
信号检测
chidamide
innovative drug
heart failure
interstitial pneumonia
signal detection
