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

目的通过对抗HCV新药索磷布韦致消化功能障碍不良反应进行信号挖掘,为评估其用药安全性提供参考。方法采用报告比值比法(ROR法)对美国不良事件报告系统(AERS)2014年-2016年第1季度索磷布韦引起的消化功能障碍不良反应报告进行信号挖掘,并对信号在性别、年龄和剂量中的分布进行分析。计数资料组间比较采用χ~2检验。结果共检测到17个不良反应信号,其中15个尚未被说明书收录。ROR值相对较大的不良反应信号为胃静脉曲张出血(58.41)、食管静脉曲张出血(47.92)、胃静脉曲张(20.02)、食管静脉曲张(17.60)、腹水(14.92)等,所有不良反应信号强度均较弱。上述信号在性别(P<0.001)、年龄(P=0.009)及用药剂量(P=0.002)分布中差异均存在统计学意义。结论对索磷布韦致消化功能障碍不良反应信号的挖掘及分析,可为全面系统地评价其目标系统安全性提供参考。

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.