临床肝胆病杂志2018，Vol.34Issue(1)：68-72,5.DOI:10.3969/j.issn.1001-5256.2018.01.014
抗HCV新药索磷布韦致消化功能障碍不良反应事件的信号挖掘及分析
Signal mining and analysis of the adverse drug reaction of digestive dysfunction caused by the new anti-HCV drug sofosbuvir
寇国先 1王宇 2郭军 3刘茜4
作者信息
- 1. 绵阳市中心医院 感染科, 四川 绵阳 621000
- 2. 绵阳市中心医院 药学部, 四川 绵阳 621000
- 3. 绵阳市中心医院 小儿内科, 四川 绵阳 621000
- 4. 绵阳市中心医院 消化内科, 四川 绵阳 621000
- 折叠
摘要
Abstract
Objective To investigate the safety of a new anti-HCV drug, sofosbuvir, through mining the adverse drug reaction (ADR) signals of digestive dysfunction caused by this drug. Methods The reporting odds ratio (ROR) was used for mining the ADR signals of digestive dysfunction caused by sofosbuvir from 2014 to the first quarter of 2016 in the American Adverse Event Reporting system, and the distribution of signals among patients with different sexes, ages, and doses was analyzed. The chi-square test was used for comparison of categorical data between groups. Results A total of 17 ADR signals were detected, among which 15 were not included in the package insert.Among these signals, gastric variceal bleeding had the highest ROR value of 58. 41, followed by esophageal variceal bleeding (47. 92), gastric varices (20. 02), esophageal varices (17. 60), and ascites (14. 92), and all ADR signals had low intensity. There was a significant difference in the distribution of these signals between patients with different sexes (P ＜ 0. 001), ages (P = 0. 009), or doses (P = 0. 002) .Conclusion Mining and analysis of ADR signals of digestive dysfunction caused by sofosbuvir can provide a reference for a comprehensive and systematic evaluation of the safety of target system.关键词
肝炎病毒属/索磷布韦/消化不良/不良反应/信号挖掘分析Key words
hepacivirus/sofosbuvir/dyspepsia/adverse drug reactions/signals mining and analysis分类
医药卫生引用本文复制引用
寇国先,王宇,郭军,刘茜..抗HCV新药索磷布韦致消化功能障碍不良反应事件的信号挖掘及分析[J].临床肝胆病杂志,2018,34(1):68-72,5.
