摘要
目的分析全国2013年~2017年双环醇片治疗肝损伤的不良反应报告。方法对2013年~2017年国家药品不良反应监测系统数据库中全国使用双环醇片出现的不良反应发生率及类别进行统计分析。结果双环醇不良反应发生率稳定在万分之一左右,严重不良反应发生率为百万分之三点五,无死亡病例。对照国际医学科学组织委员会推荐的不良反应标准,属于罕见或十分罕见。结论双环醇不良反应发生率低,且均为轻度或中度反应。在临床实际应用中安全性好。
Objective To analysis the adverse effect of bicyclol tablets in the treatment of liver injury in China from 2013 to 2017. Methods To make statistically analyses of Bicyclol＇ s adverse effect incidence rate and classifications from the database of the National Drug Adverse Drug Reaction Monitoring System during the period from 2013 to 2017. Results The adverse effect incidence rate of Bicyelol tablets is about 0.01%, and the serious adverse effect incidence rate is 0.00035%. There is no death case. Compared to the standard incidence rate of adverse effect proposed by CIOMS, this belongs to rare or extremely rare circumstance. Conclusion The adverse effect incidence rate of Bicyclol tablets is low, and the degree are mild or moderate. So Bicyclol tablets is safe in clinical application.
作者
陈赛男
王晨
黄霁秋
罗金
王星
CHEN Sainan;WANG Chen;HUANG Jiqiu;LUO Jin;WANG Xing(Beijing Union Pharmaceutical Factory,Department of Medicine,Beijing,102629)
出处
《首都食品与医药》
2018年第22期60-61,共2页
Capital Food Medicine
关键词
双环醇片
肝损伤
不良反应
Bicyclol tablets
liver injury
adverse effect
